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Vanderbilt Evidence-based Practice Center

AARC Review: Effectiveness of Pharmacologic Agents to Promote Airway Clearance in Hospitalized Patients

Nila A. Sathe, MA, MLIS Jeff Andrews, MD Shanthi Krishnaswami, MBBS, MPH Cathy Ficzere, PharmD Melissa L. McPheeters, PhD, MPH

Acknowledgements

We the appreciate contributions of Ms. Rachel Walden, who conducted the searches for this review and assisted with screening studies. We also gratefully acknowledge the American Association for Respiratory Care (AARC) Pharmacologic Airway Clearance Clinical Practice Guidelines Committee. Their insight into scoping the literature and reviewing studies was invaluable. The committee includes:

Chairperson: Shawna Strickland, PhD, RRT-NPS, RRT-ACCS, AE-C, FAARC AARC Irving, TX

Members: Richard Branson, MS, RRT, FAARC University of Cincinnati College of Medicine Cincinnati, OH

Gail Drescher, MA, RRT Washington Hospital Center Washington DC

Carl Haas, MLS, RRT-ACCS, FAARC University Hospitals and Health Centers Ann Arbor, MI

Catherine O’Malley, RRT-NPS Ann & Robert H. Lurie Children’s Hospital of Chicago Chicago, IL

Bruce Rubin, MD, MEngr, MBA, FAARC Virginia Commonwealth University Richmond, VA

Teresa Volsko, MHHS, RRT, FAARC Akron Children’s Hospital

Dean Hess, PhD, RRT, FAARC Ex-officio Boston, MA

Ray Masferrer, RRT, FAARC Ex-officio Dallas, TX

Table of Contents Introduction ...... 1 Methods ...... 1 Topic refinement and key questions ...... 1 Literature search strategy ...... 2 Inclusion and exclusion criteria ...... 2 Study selection ...... 4 Data extraction and synthesis ...... 4 Quality (Risk of Bias) assessment of individual studies ...... 5 Strength of the body of evidence for each key question ...... 5

Results ...... 6 Article selection ...... 6 Sumary of results by agent ...... 8 Summary of results by outcome ...... 13 Stength of the evidence ...... 15

Discussion ...... 16 Overview ...... 16 Methodologic considerations and limitations ...... 16 Future research ...... 16 Conclusions ...... 16

References ...... 18

List of Tables and Figures Table 1. Inclusion and exclusion criteria ...... 3 Table 2. Quality rating algorithm ...... 5 Table 3. Overview of included studies ...... 7 Table 4. Summary of key findings of studies of acetylcysteine ...... 10 Table 5. Summary of key findings of studies of albuterol ...... 12 Table 6. Summary of key findings of studies of ipratropium bromide ...... 12 Table 7. Summary of key findings of studies of heparin and acetylcysteine ...... 13 Table 8. Summary of between group differences in final outcomes ...... 15 Table 9. Number of randomized trials reporting key outcomes by quality rating ...... 15 Figure 1. Disposition of studies indentified for this review ...... 6

Appendices A. Search strategy B. Review forms C. Evidence tables D. Excluded studies E. Quality of the literature F. Harms Data Reported in Product Labeling G. Abbreviations and acronyms

Introduction Mucus hypersecretion can be pathologic in individuals with severe respiratory disease or impaired cough. While airway cilia clear mucus continually in healthy individuals, in the presence of inflammation or infection mucus production increases, ciliary function may become impaired, and the biophysical properties of sputum may change.1, 2 Mucus hypersecretion is associated with declines in pulmonary function and quality of life, excess cough, discomfort, and exacerbation of conditions like chronic obstructive pulmonary disease (COPD).3, 4 Mucoactive agents may increase sputum expectoration or decrease hypersecretion of mucus.1, 5, 6 Mucolytic agents such as acetylcysteine alter disulphide bonds that comprise mucus proteins and may decrease mucus viscosity.1, 5, 6 Other mucolytics such as dornase alpha break down DNA polymers or networks of actin filaments that develop in purulent secretions. Expectorants may promote loosening of airway secretions. Agents such as saline may rehydrate mucus and promote cough.7 Mucoregulatory agents target chronic hypersecretion by goblet cells and submucosal glands.1, 5, 6 Agents include corticosteroids, macrolide antibiotics, and anticholinergics such as ipratropium bromide. Mucokinetic agents such as bronchodilators promote clearance by increasing action of the ciliary and may facilitate mucus transportability.1, 2, 7 Surfactants may also reduce mucus adhesiveness and increase transportability.6 The goal of the current project was to systematically review comparative studies of pharmacologic agents that respiratory therapists and other health professionals can employ to achieve mucus clearance in hospitalized or postoperative patients over the age of 12 months. The American Association for Respiratory Care (AARC) commissioned the review, and AARC committee members participated in the review process. As a collaborative effort, the AARC team and the Vanderbilt Evidence-based Practice Center (EPC) developed the key questions, inclusion and exclusion criteria and engaged in identification and review of abstracts. This team has previously reviewed the benefits and harms of nonpharmacologic airway clearance techniques in hospitalized patients.8

Methods Topic Refinement and Key Questions We drafted key questions and determined outcomes and interventions of interest via an iterative process involving team members with clinical and/or with methodologic expertise. Through conference call and email discussions, we decided to focus this review on pharmacologic airway techniques in individuals over one year of age. We addressed the following key questions:

• In hospitalized, adult and pediatric patients without cystic fibrosis, does the use of pharmacologic therapies used in airway clearance improve oxygenation, reduce length of time on the ventilator, reduce readmission to hospital or ED admission, reduce length of stay in the intensive care unit (ICU), change sputum properties, reduce incidence of infection, affect quality of life, and/or improve respiratory mechanics vs. usual care? • In hospitalized adult and pediatric patients with neuromuscular disease, respiratory muscle weakness, or impaired cough, does the use of pharmacologic therapies used in airway clearance improve oxygenation, reduce length of stay in the hospital, reduce length of time on the ventilator, reduce readmission/emergency department (ED) visits, improve perceived quality of life, reduce incidence of infection, and/or change sputum properties vs. usual care?

• In postoperative adult and pediatric patients, does the use of pharmacologic therapies used in airway clearance improve oxygenation, reduce length of time on the ventilator, reduce length of stay in the hospital and/or ICU, reduce readmission, reduce incidence of infection, and/or change sputum properties vs. usual care? Literature Search Strategy

Databases and Search Strategies A librarian employed search strategies provided in the appendix to retrieve relevant research on pharmacologic airway clearance therapies. All strategies were peer reviewed by a second librarian. Our primary literature search employed the MEDLINE® (via the PubMed interface) EMBASE databases. Our search strategies used a combination of subject heading terms appropriate for each database and key words relevant to airway clearance (e.g., sputum clearance, chest physical therapy). We limited searches to literature published in English since 1970 to ensure that early literature on the introduction of mucoactive agents would be represented. Our searches were conducted in July 2014. We imported all citations into an electronic database and into the DistillerSR program for screening. We also manually searched the reference lists of included studies and of recent narrative and systematic reviews and meta-analyses addressing pharmacologic airway clearance in adults to locate citations of potential relevance. Inclusion and Exclusion Criteria Studies had to include individuals over one year of age without cystic fibrosis who were receiving pharmacologic airway clearance agents and who were hospitalized; had neuromuscular disease or respiratory muscle weakness; or who had impaired cough. We excluded studies of patients with cystic fibrosis as the Cystic Fibrosis Foundation recently published guidelines specifically related to airway clearance.9 Studies had to report on one of the following agents explicitly used to promote airway clearance and include a treatment group and an appropriate comparison group:

• Beta-agonists: albuterol sulfate, salmeterol, xopenex, formoterol, salbutamol, pirbuterol • Anti-cholinergics: ipratropium bromide, oxitropium bromide, glycopyrrolate, tiotropium bromide • Mucoactive drugs: N-acetylcysteine, dornase alfa, sodium bicarbonate, hypertonic saline, guaifenesin, normal saline • Novel therapies: inhaled heparin; inhaled “burn cocktail” of heparin and n-acetylcysteine, albuterol and n-acetylcysteine; inhaled TPA Comparators included other pharmacologic airway clearance approaches, no airway clearance intervention, or placebo. We also required that studies address one of the following outcomes related to the effects of the intervention on mucus clearance:

• ICU or hospital length of stay (LOS) • Time to re-admission • Number of hospital admissions or hospital days • Quality of life

• Pulmonary function (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC], peak flow) • Sputum clearance and expectoration (transport, weight, volume) • Change in sputum properties • Incidence of infection • Harms (including mortality) specifically related to airway agents used • Oxygenation.

We included studies with any length of followup and in the hospital setting (i.e., not home- or outpatient clinic-based). Table 1 summarizes these criteria.

Table 1. Inclusion and exclusion criteria Category Criteria Study population • Hospitalized or postoperative patients over 1 year of age and without cystic fibrosis receiving pharmacologic airway clearance agents of interest • Patients with neuromuscular disease or respiratory muscle weakness over 1 year of age and without cystic fibrosis and receiving pharmacologic airway clearance agents of interest • Patients with impaired cough over 1 year of age and without cystic fibrosis and receiving pharmacologic airway clearance agents of interest Time period • 1970–present Publication languages • English only Admissible evidence (study design and Admissible designs other criteria) • Controlled trials, observational studies including prospective cohort studies Other criteria • Original research studies that provide sufficient detail regarding methods and results to enable use and adjustment of the data and results • Patient populations must include individuals as noted above • Studies must address one or more of the following agents: o Albuterol Sulfate o Salmeterol o Xopenex o Formoterol o Salbutamol o Pirbuterol o Ipratropium Bromide o Oxitropium Bromide o Glycopyrrolate o Tiotropium Bromide o N-Acetylcysteine o Dornase Alfa o Sodium Bicarbonate o Hypertonic Saline Or Normal Saline o Guaifenesin o Inhaled Heparin o Inhaled Heparin and N-Acetylcysteine o Inhaled Albuterol and N-Acetylcysteine o Inhaled Tpa

Admissible evidence (study design and • Studies must provide baseline and outcome data for one or more of the other criteria, continued) following outcomes of interest: o ICU or hospital length of stay (LOS) o Time to re-admission o Number of hospital admissions or hospital days o Quality of life o Pulmonary function (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC], peak flow) o Sputum clearance and expectoration (transport, weight, volume) o Change in sputum properties o Incidence of infection o Harms (including mortality) specifically related to airway agents used o Oxygenation Or outcome data for: o Antibiotic use as affected by airway clearance o Harms (including mortality) related to airway clearance interventions o ICU or hospital length of stay o Number of hospital admissions or hospital days • Studies must include extractable data on relevant outcomes, including data presented in text or tables (vs. solely in figures) • Study must be hospital- or inpatient-based FET=forced expiratory technique; FEV1=forced expiratory volume in 1 second; FVC=forced vital capacity; HR=heart rate; ICU=intensive care unit; PEP=positive expiratory pressure Study Selection

Screening of Studies Once we identified potential articles through the electronic database searches, review articles, and bibliographies, we examined the abstracts to determine whether studies met our criteria. Two reviewers separately evaluated each abstract for inclusion or exclusion, using an Abstract Review Form (Appendix). If one reviewer concluded that the article could be eligible for the review based on the abstract, we retained it for full text assessment. Two reviewers independently assessed the full text of each included study using a standardized form (Appendix) that included questions stemming from our inclusion/exclusion criteria. Disagreements between reviewers were resolved by a third-party adjudicator. The group of abstract and full text reviewers included expert clinicians and health services researchers, and we required that studies be excluded by at least one clinician and one methodologist. AARC members involved in screening were paired with EPC staff in order to maintain rigor and protect against bias. Data Extraction and Synthesis We extracted data on study design, population characteristics (including age, underlying conditions, and need for mechanical ventilation), intervention characteristics (including type and duration of intervention and concomitant therapies), and key outcomes data into evidence tables. One team member initially entered information into the evidence table. Another member of the team independently reviewed the articles and edited all initial table entries for accuracy, completeness, and consistency. In addition to outcomes related to airway clearance intervention effectiveness, we extracted all data available on harms of airway clearance. Harms encompass the full range of specific negative effects, including the narrower definition of adverse events.

Meta-analysis is the use of statistical methods to combine results of individual studies. The decision about whether or not the results of individual studies are similar enough to be combined in a meta- analysis is essential to the validity of the result. Meta-analysis requires a similar outcome measure from a study of a similar intervention compared to a similar control, and similar populations. If two or more such studies are identified, the next step is the extraction of data from each individual study and the calculation of a result for that study (“estimate of the size of the effect,” the “point estimate,” or “summary statistic”) with an estimate of the chance variation we would expect with studies like that (the confidence interval). The final step is deciding whether it is appropriate to calculate a pooled average estimate of effect across studies and, if so, calculating and presenting such a result. Part of this process is weighting the average, by giving greater weight to the results from studies that give us more information, because these are likely to be closer to the truth we are trying to estimate. We determined that the differences among populations, interventions, controls, and outcome measures rendered meta- analysis inappropriate. Thus, analysis remains qualitative. Quality (Risk of Bias) Assessment of Individual Studies We assessed quality using separate tools as appropriate by study design. Tools included the Cochrane Risk of Bias tool for randomized controlled trials (RCTs) and the Newcastle-Ottawa scale for cohort studies. We rated the quality for key outcomes for which data were provided; if a study noted, for example, that a given was outcome was not significantly different between groups but did not provide the relevant data, we did not rate quality for that outcome. Two reviewers independently assessed quality for each study, with final decisions made via discussion to reach consensus or by third party adjudication by a senior methodologist, as needed. We used the parameters outlined in Table 2 to translate quality ratings into final levels (good, fair, poor). We considered that “good” studies could not have any criteria rated as high risk of bias. For studies with “unclear” ratings, we considered the likelihood that a factor would bias a given outcome and the importance of the limitation and “downgraded” the final level as appropriate.

Table 2. Quality rating algorithm Low RoB criteria High RoB criteria Unclear RoB criteria Quality Level 7 0 0 Good 6 0, 1 0, 1 Good or Fair 5 0, 1 1, 2 Good or Fair 5 2 0 Fair or Poor 4 0-2 0-3 Fair or Poor 0-3 0-7 0-7 Poor 0-7 3-7 0-7 Poor 0-7 0-7 4-7 Poor RoB=risk of bias Strength of the Body of Evidence for Each Key Question The degree of confidence that the observed effect of an intervention is unlikely to change is presented as strength of evidence. Strength of evidence can be regarded as insufficient, low, moderate, or high. It describes the adequacy of the current research, in quantity and quality, and the degree to which the entire body of current research provides a consistent and precise estimate of effect.

Results Article Selection We reviewed 4303 abstracts and 310 full-text papers and determined that eight papers (comprising nine unique studies) met inclusion criteria (Figure 1). Because so few studies met our criteria, we have organized the results by agent and outcomes rather than presenting them by key question.

Figure 1. Disposition of studies identified for this review

Records identified through database Additional records identified through searching other sources (n = 4239) (n = 64)

Identification

Records excluded Records screened (n = 3993) (n = 4303 )

Screening

Full-text articles excluded, with reasonsa (n = 302)

Full-text articles assessed for

eligibility • Ineligible population (n = 310) n = 262

Eligibility • Did not address interventions of interest n = 232

• Did not include appropriate comparison

Studies included in qualitative group or ineligible study design synthesis n = 144 n=9 (reported in 8 papers)

Included • Did not address outcomes of interest n = 226

• Ineligible setting n = 268

• Not original research

n = 83

• Study not obtainable or not in English n = 7 a Numbers do not tally as studies could be excluded for multiple reasons. n=number.

The nine studies (reported in eight publications) that met review criteria included four RCTs, four crossover RCTs, and one retrospective cohort study (Table 3). Studies were small and together included a total of 379 patients (mean=42 patients/study). Five studies were conducted in ≤ 7 days (mean duration in these five studies=5 days). Two studies, one conducted in a skilled nursing facility in mechanically ventilated patients10 and one in Veterans’ Administration hospital,11 were conducted over 5 and 3 weeks, respectively. Duration of intervention was not clearly reported in two studies (reported in a single publication).12 Studies were conducted in the United States,10-13 the United Kingdom,14 Denmark,15 Iran,16 and Australia.17 Table 3. Overview of included studies Characteristic RCT Crossover RCT Cohort Total Literaturea N studies 5 3 1 9 Population Adult 5b 3 0 8 Pediatric 0 0 1 1 Underlying conditionc Asthma 1 0 0 1 Bronchitis 0 2 0 2 Burn injury 0 0 1 1 COPD 1 0 0 1 Postoperative 3 0 0 3 Agentsd Acetylcysteinee 5 1 0 6 Albuterol 0 1 0 1 Heparin+acetylcysteine 0 0 1 1 Ipratropium bromide 0 1 0 1 Saline 2 1 0 3 Country Asia 1 0 0 1 Australia 1 0 0 1 Europe 1 1 0 2 US or Canada 2 2 1 5 a One publication included 2 studies in separate populations.12 b Age not reported in 2 studies. We assumed these were conducted in adult populations. c One study10 included mechanically ventilated patients with pulmonary or neurologic conditions. d Studies could address more than one agent. e One study assessed acetylcysteine + isoproterenol in saline. RCT=randomized controlled trial

The following sections summarize results of studies meeting our criteria and categorized by agent. Most studies were conducted in adults and most assessed acetylcysteine (n=6), either alone or in combination with another agent. We note that individual studies referred to acetylcysteine by various names, but we have used “acetylcysteine” in our discussion of results for consistency. Tables summarizing study results list the drug name as reported in each study. Adult populations included postoperative patients (n=3 studies), individuals with chronic bronchitis (n=2 studies) or asthma (n=1 study), patients with COPD exacerbation (n=1 study), and long-term

7 mechanically ventilated patients (n=1 study). A single retrospective cohort study in pediatric patients evaluated heparin plus acetylcysteine in mechanically ventilated burn patients. Summary of Results by Agent Acetylcysteine Three small RCTs (one of good quality for all outcomes) evaluated acetylcysteine in patients with asthma, COPD, or bronchitis (Table 4). The good quality RCT was conducted in Australia and assessed the effects of acetylcysteine on COPD exacerbations in long-term smokers who were >=50 years old.17 Investigators randomized participants to either 600 mg of oral acetylcysteine twice daily in addition to usual care (n=25, mean age=73.6 ±7.8) or placebo (n=25, mean age=73±8.2) for 7 days or until discharge and measured the primary outcome of breathlessness (Likert scale from 1=extremely short of breath to 7=not at all short of breath) daily two hours after the last dose of nebulized bronchodilator. Groups did not differ at baseline on age, smoking history, pulmonary function tests, use of bronchodilators and inhaled corticosteroids prior to admission, or breathlessness. While the rate of change in breathlessness score, FEV1, and oxygen saturation was greater in the placebo arm, changes were not significantly different between groups. Median length of stay was 6.0 days in the acetylcysteine arm and 5.5 days in placebo (p=NR). Two participants in the placebo arm and one in the acetylcysteine arm reported nausea. We considered this study as poor quality for harms reporting.

A U.S.-based double-blind randomized crossover trial compared two concentrations of acetylcysteine plus isoproterenol with standard respiratory care, which included isoproterenol, mucoactive drugs, expectorants, and humidification, in 20 male patients with chronic bronchitis (n=17) or asthmatic bronchitis (n=3).11Patients ranged in age from 47 to 73 years and received standard therapy, including .05% isoproterenol delivered via an intermittent positive-pressure breathing device in the first study week. In the second and third weeks patients continued standard care and also received either 0.5% acetylcysteine plus .05% isoproterenol in 0.9% saline, 4 ml three times daily or 10% acetylcysteine plus .05% isoproterenol, 4ml three times daily in random order. The agents were delivered using a positive-pressure breathing device, and investigators compared the mean daily volume of sputum for each week, sputum viscosity, and pulmonary function. Mean daily sputum volume did not differ significantly among groups, but viscosity was significantly less in the 10% acetylcysteine week than in the other weeks (p<.01). Spirometry measures (FEV1 , forced vital capacity, mid-expiratory flow rate, maximum midexpiratory flow, maximum voluntary ventilation) were lowest in the control week and did not change significantly in the subsequent weeks. The investigators reported that no instances of toxicity or adverse reactions occurred. We considered this study as fair quality for the outcomes of sputum volume, viscosity, pulmonary function, and poor quality for harms.

In one single-blind, placebo-controlled RCT conducted in Iran, 25 patients with asthma exacerbation received usual care plus 600 milligrams oral acetylcysteine twice a day (mean age=50 ± 15.74 years, mean asthma duration 8.08 ± 7.12 years).16 The 25 patients in the control arm (mean age=47.8 ± 12.06 years, mean asthma duration=7.96 ± 8.53 years) received usual asthma care. All participants in both

8 groups received inhaled corticosteroids, systemic corticosteroids, inhaled beta2 agonists, and macrolide antibiotics (n=15 in acetylcysteine arm and 12 in control arm) during the study period. Groups did not differ significantly at baseline on demographic measures or on measures of severity of dyspnea, wheezing, cough, sputum amount, difficulty in expectoration, or morning peak expiratory flow rate. At day 5 symptom severity in both groups had improved from baseline, but between group differences were not significant. The study did not report adverse events. We rated this study as poor quality for the outcomes of dyspnea, wheezing, cough, sputum amount, ease of expectoration, and sleep quality. The study was of fair quality for the outcome of peak expiratory flow rate.

Three studies included postoperative patients. A double-blind RCT conducted in Denmark compared acetylcysteine (n=64) with placebo (n=67) in patients undergoing upper laparotomy.15 We rated this study as poor quality for all outcomes, including harms. Surgical procedures included cholecystectomy (55% of acetylcysteine arm and 61% in placebo) and biliary or gastric surgeries (45% in acetylcysteine arm and 39% in placebo). The overall mean age of patients was 53.3 years (56.1 in acetylcysteine group and 50.7 in placebo; significance testing not reported), and groups did not differ significantly in terms of sex, number of smokers, percent overweight, and major vs. minor surgeries. Patients in the acetylcysteine arm received a total of 1200 mg acetylcysteine orally the day before surgery and 200 mg intravenously or orally three times a day for 6 days or until discharge. Investigators assessed pulmonary function preoperatively and on postoperative days 1, 3, and 5 and used chest x-rays to evaluate atelectasis on postoperative days 2 and 4. By day 6 only 60 patients remained in the study (30 in each arm). At 6-days post-surgery, the between-group difference in mean actual and preoperative alveolo- arterial-O2 difference was not significant, nor was it significantly different between groups on any day. Vital capacity and FEV1 improved in both groups by day 6 (acetylcysteine median=17.9% vs. 23.8% in placebo; acetylcysteine median=21.4% vs. 26.4% in placebo, respectively) but between-group differences were not significant. In covariate analyses, no pulmonary function outcomes differed by smoking or overweight status, type of surgery, or reduction in preoperative pulmonary values. Fifty percent of the acetylcysteine arm and 47% of placebo had atelectasis on day 4, and 3% overall had pneumonic infiltrations; differences in frequency of atelectasis or infiltrations between groups were not significant (p=0.18 for atelectasis). Investigators reported that no harms were recorded in the study period.

One study reported non-comparative data as well as outcomes of two unblinded, randomized trials of acetylcysteine to minimize atelectasis in two different populations of postoperative patients; we considered both studies to be poor quality for all outcomes.12 The study does not report patient characteristics; however one trial compared acetylcysteine (10% solution, 2 ml every 2 hours for 10 doses after anesthesia recovery) or physiologic saline (2 ml every 2 hours) in 40 abdominal surgery patients (20 in each arm), and another trial compared either intratracheal-instilled acetylcysteine with nebulized acetylcysteine delivered via an intermittent positive-pressure breathing device in another 40 abdominal surgery patients. In both trials patients received normal postoperative nursing care, and atelectasis was assessed via chest x-rays. In the first trial, 9 of 20 patients in the saline arm compared with 2 of 20 in the acetylcysteine arm developed atelectasis. The incidence of atelectasis did not differ

9 between groups receiving either the intratracheal instilled agent or the agent delivered via the positive- pressure breathing device (n=4/20 patients with atelectasis in both arms). The study also reports data on the number of patients by surgical type who received or did not receive acetylcysteine and who developed atelectasis, though it is not clear if these patients include the abdominal surgery patients described in the trials. While the number of patients receiving each type of surgery varied, 33 of 124 patients who did not receive the agent developed atelectasis, with the highest rates after gynecologic surgeries (60%, n=3/5), colonic surgeries (38%, 3/8), and lung pneumonectomy (33%, 2/6). Fourteen of 97 patients who received acetylcysteine developed atelectasis with highest rates after gastric surgeries (33%, 3/9), thoracic surgeries (23%, 3/13), and biliary tract surgeries (21%, 4/19). The study notes that an unstated number of patients complained of nausea and decreased appetite related to acetylcysteine, and one patient had “serious” bleeding at the puncture site for intratracheal instillation.

Table 4. Summary of key findings of studies of acetylcysteine Author, Year Groups, Population/Underl Key Findings Country N enrollment/N final ying condition

Study Design Age, mean years ± SD Black et al. G1: Oral NAC, 25/25 Smokers with • Mean change in breathlessness score in G1 2004 17 G2: Placebo, 25/25 COPD exacerbation was 0.7 points and 0.8 points in G2; mean Australia change in FEV1 in liters was .03 in G1 and .15 G1: 73.6 ± 7.8 in G2; mean change in oxygen saturation RCT G2: 73.0 ± 8.2 percentage was 1.2 in G1 and 1.8 in G2. No significant differences in any measure • No significant differences in length of stay • Nausea reported in 2 patients in G2 and one in G1 Pulle et al. G1: Nebulized Chronic or • 17 patients had chronic bronchitis, and usual 197011 acetylcysteine asthmatic bronchitis care included nebulized isoproterenol (.05%) US 10%+Isoproterenol • Mean daily sputum volume not significantly G2: Nebulized G1+G2+G3: 47-73 different among groups Crossover acetylcysteine • Decrease in sputum viscosity in 10% RCT .05%+Isoproterenol acetylcysteine week compared with other G3: Standard respiratory weeks (p<.01) care • No significant changes in pulmonary function tests G1+G2+G3: 20/20 • No instances of toxicity or other adverse reactions Aliyali et al. G1: Oral NAC+standard Asthma • No group differences in scores for wheezing, 201016 care, 25/25 exacerbation cough, sleep, dyspnea, sputum amount, Iran G2: Placebo+standard morning peak expiratory flow rate, and care, 25/25 G1: 50 ±15.74 difficulty in expectoration RCT G2: 47.8±12.06 • Adverse events were not reported Jepsen et al. G1: Oral and iv NAC, Postoperative upper • No significant group differences in pulmonary 198915 62/30 laparotomy patients function tests though measures typically Denmark G2: Placebo, 67/30 improved in both groups over time G1: 56.1 (mean) • No significant differences in atelectasis or RCT G2: 50.7 (mean) pulmonary infiltrates (50% of participants in G1 and 47% in G2) • No significant differences in analyses accounting for smoking status, overweight, operation, or preoperative vital capacity or FEV1 reduction • No adverse events in study period

Thomas et al. Experiment 1 Postoperative Experiment 1 12 1966 G1: Intra-tracheal N- abdominal surgery • 4 patients in G1 and 9 in G2 developed US acetyl-L-cysteine, 20/20 patients atelectasis G2: Intra-tracheal saline, RCT 20/20 Age: NR Experiment 2 • 4 patients in each arm developed atelectasis Experiment 2 G1: Intra-tracheal N- Harms reported (not clear in which set of patients acetyl-L-cysteine, 20/20 harms occurred) include bleeding (n=1), G2: Intermittent positive subcutaneous, nausea (n=NR), decreased pressure delivered- N- appetite (n=NR) acetyl-L-cysteine, 20/20

COPD-chronic obstructive pulmonary disease; FEV1-forced expiratory volume in one second; G-group; iv-intravenous; NAC-N- acetylcysteine; NR-not reported

Albuterol One randomized, placebo-controlled crossover study conducted in the United States included 14 mechanically ventilated patients in a long-term care facility (median age=72 years, range=35-93; median duration of intubation=21 months, range 4-108) (Table 5).10 Six participants had COPD, and one had idiopathic pulmonary fibrosis. Neurologic conditions included amyotrophic lateral sclerosis (n=2), neuropathy (n=2), myopathy (n=2) and encephalopathy (n=1). Participants underwent a 2-week washout phase in which all aerosolized bronchodilators were discontinued. Participants receiving inhaled corticosteroids (n=1), systemic corticosteroids (n=2) and beta-sympathomimetic antagonists (n=1) continued those medications. Investigators measured secretion volume daily for one week following the washout period to establish control volumes. Following this week, participants received, in random order, 5 days of either an R-enantiomer formulation (R-albuterol), 1.25 mg/3 mL three times a day; racemic albuterol 2.5 mg/3 mL three times a day; or normal saline 3 mL three times a day. Treatments were nebulized and were given each weekday with each weekend serving as a washout period between treatments. All participants completed the control period, 12 completed the saline phase, 14 completed the racemic albuterol phase, and 13 completed the R-albuterol phase. Investigators collected secretions from suctioning (provided at medication administration and as needed) and cough and mucociliary clearance for 4 hours after each treatment and totaled all values for a 5-day aggregate volume after the first hour of collection and after 4 hours of collection. Differences in aggregate 4-hour sputum volume over 5 days were not significantly different among groups (mean ± SEM in the control period=31.00 ± 8.92 mL, saline=25.08 ± 5.50 mL, racemic albuterol=24.93 ± 4.85, R-albuterol=26.92 ± 6.79) nor were daily 4-hour aggregate differences or differences after one hour of collection. For all three treatments, volume on the first day of collection after starting a treatment was greater at the first hour measurement than at 4 hours (p=0.014). Neither mean electrolyte concentrations nor mean inflammatory indices differed significantly among treatment groups. The study reported that there were no adverse events related to the study drugs. We rated the study as fair quality for the outcomes of sputum volume and electrolyte concentrations and inflammatory indices and poor quality for harms.

Table 5. Summary of key findings of studies of albuterol Author, Year Groups, Population/ Underlying Key Findings Country N enrollment/N final condition

Study Design Age, median (range)

O’Riordan et G1: Nebulized R- Mechanically ventilated • No significant group differences in al. 2006 10 albuterol patients in skilled secretion volume at any collection point US G2: Nebulized racemic nursing facility • Secretion volume greater on first albuterol treatment day vs. 4 following days in all 3 Crossover G3: Nebulized saline G1+G2+G3: 72 (35-93 ) groups RCT • Mean electrolyte concentrations and G1+G2+G3: 17 inflammatory indices did not differ among groups • No adverse events related to study medications G-group

Ipratropium Bromide In a poor quality randomized crossover trial conducted in Scotland, 12 inpatients with chronic bronchitis received 40 micrograms of aerosolized ipratropium bromide or a placebo containing a propellant only in random order (Table 6).14 Participants (no baseline characteristics provided) received each treatment for 2 days, and investigators measured the volume of collected sputum after 24 hours and the viscosity of sputum. Mean change in viscosity in the ipratropium arm was 91.6 ± 44.3 centipoise and 73.0 ± 29.6 in the placebo arm (t=1.90). Mean change in sputum volume at 24 hours was 33.3 ± 19.7 ml in the ipratropium arm and 34.0 ± 20.4 in placebo (t=0.31). While the study does not report baseline values, the investigators note that increases in volume or viscosity were not significant. The study also did not report adverse events.

Table 6. Summary of key findings of studies of ipratropium bromide Author, Year Groups, Population/ Underlying Key Findings Country N enrollment/N final condition

Study Design Age, median (range)

May et al. G1: Nebulized Chronic bronchitis • No significant increase in mean sputum 1977 14 ipratropium bromide viscosity or volume between groups UK G2: Placebo Age: NR • Study did not report adverse events

Crossover G1+G2: 12 RCT G-group; NR-not reported; RCT-randomized controlled trial Heparin+Acetylcysteine One fair quality cohort study compared aerosolized heparin and acetylcysteine in pediatric burn patients with inhalation injury and requiring mechanical ventilation to children receiving standard inhalation injury care (Table 7).13 Forty-seven children admitted to one U.S. hospital received standard care plus 5000 units aerosolized heparin alternating with 3 ml of a 20% solution of acetylcysteine every 2 hours for the first 7 days after injury (mean age=7.7±5). Children in the control arm (n=43, mean age=8.2±6) received standard inhalation injury care (ventilatory support, humidified oxygen, chest

12 physical therapy, suctioning, bronchodilation, ambulation). Children did not differ significantly in age, percent of total body surface burned, or length of stay. Significantly fewer children in the heparin and acetylcysteine arm required reintubation for pulmonary failure (3/47 vs. 12/43), had atelectasis (20/47 vs. 30/43), or died (2/47 vs. 8/43) compared with controls (all p values <.05). The treatment group required fewer ventilator hours than the control group (mean 81±93 vs. 187±79, calculated p value [unpaired t test] <.0001). The study did not report adverse events.

Table 7. Summary of key findings of studies of heparin and acetylcysteine Author, Year Groups, Population/ Underlying Key Findings Country N enrollment/N final condition

Study Design Age, mean ± SD

Desai et al. G1: Aerosolized heparin Mechanically ventilated • Significantly less need for re-intubation in 13 1998 and acetylcystine, 47/47 children with burn and G1 vs. G2 (3 vs. 12, p<.05) US G2: Standard inhalation inhalation injury • Less mortality in G1 vs. G2 and less injury care, 43/43 atelectasis (20 vs. 30), p values <.05 Retrospective G1: 7.7 ± 5 • Ventilator hours in G1=81±93, in G2: cohort study G2: 8.2 ± 6 187±79 • Adverse events not reported

G-group Summary of Results by Outcome Sputum Volume or Weight and Sputum Viscosity Four studies assessed sputum volume or weight with mixed results. One crossover study of varied concentrations of acetylcysteine plus isoproterenol reported no group differences in sputum volume,11 as did another RCT assessing acetylcysteine vs. placebo in patients with asthma exacerbation.16 Crossover RCTs of ipratropium bromide and albuterol reported no group differences in secretion volume.10, 14 One crossover study of acetylcysteine reported decreases in sputum viscosity after treatment.11 One crossover trial of ipratropium reported no increase in viscosity after ipratropium.14

Expectoration One study of acetylcysteine reported no differences in ease of expectoration between the acetylcysteine and placebo groups.16

Pulmonary Function Four studies reported no differences in pulmonary function measures associated with treatment: one crossover RCT of acetylcysteine and isoproterenol,11 two RCTs of acetylcysteine vs. placebo,16, 17 and 15 one RCT comparing acetylcysteine and placebo. Pulmonary measures included peak flow rate, FEV1, dyspnea, and vital capacity.

Atelectasis Three studies reported on incidence of atelectasis. In one RCT of aerosolized heparin and acetylcysteine compared with placebo, fewer children in the treatment arm developed atelectasis compared with the placebo group.13 Two studies of acetylcysteine reported no group differences in atelectasis.12, 15 One of these studies reported on two separate experiments and reported no differences in development of atelectasis in one experiment and did not assess significance in the second, though 9 of 20 patients in the saline arm and 2 of 20 in the acetylcysteine developed atelectasis.

Other Outcomes and Harms of Treatments Other outcomes reported included oxygen saturation (no group difference in one RCT17), length of stay (no group differences in one RCT of acetylcysteine17); cough, wheezing, and sleep (no significant differences between groups in one RCT16); mortality, ventilation hours, and reintubation (significant differences in favor of the heparin and acetylcysteine arm vs. usual care13); and electrolyte concentration and inflammation indices (no differences in a crossover trial of albuterol10). Harms of agents were not consistently reported Nausea was reported in two studies of acetylcysteine (one paper reported two experiments and did not clearly identify in which experiment harms occurred),12, 17 three studies reported that there were no adverse events,10, 11, 15 and three studies did not address harms at all.13, 14, 16 Table 8 summarizes outcome differences for outcomes in studies reporting comparisons, and Table 9 reports outcomes by study quality. Table 8. Summary of between group differences in final outcomes

Study Groups Population Sputum Viscosity Pulmonary SaO2 Atelectasis volume/ function weight Aliyali et • Acetylcysteine Asthma -- -- 16 al. 2010 • Placebo Black et al. • Acetylcysteine COPD -- -- 17 2004 • Placebo Jepsen et • Acetylcysteine Post- -- -- 15 al. 1989 • Placebo operative Pulle et al. • Acetylcysteine (.05 or Chronic -- ! 10% -- 11 1970 10%) + isoproterenol asthma or acetyl- • Usual care bronchitis cysteine O’Riordan • R-albuterol Mechanically -- et al. 2006 • Racemic albuterol ventilated, 10 • Saline long-term care Desai et • Heparin+ Inhalation ! Heparin+ 13 al. 1998 acetylcysteine injury acetylcysteine • Usual care May et al. • Ipratropium bromide Bronchitis -- -- 14 1977 • Placebo a Thomas • Intratracheal Post- -- -- et al. acetylcysteine operative 12 1966 • IPPB acetylcysteine Up or down arrow: increase or decrease significantly different between groups; --: no significant differences between groups ; shaded cell: outcome not reported. COPD-chronic obstructive pulmonary disease; SaO2-oxygen saturation aThe second study in this publication did not report potential significance of differences in outcomes.

Table 9. Number of randomized trials reporting key outcomes by quality rating Outcome Good (n studies) Fair (n studies) Poor (n studies) Atelectasis 0 0 3 Dyspnea 1 0 1 Expectoration 0 0 1 Length of stay 1 0 0 Oxygen saturation 1 0 1 Pulmonary function 1 2 1 Sputum viscosity 0 1 1 Sputum volume/weight 0 2 2 TOTAL 4 5 10 Note: One fair quality cohort study assessed atelectasis, days on ventilator, re-intubation, and mortality. Strength of the Evidence The overall body of evidence for any agent on outcomes related to airway clearance is methodologically weak, comprises different agents and different population, and includes few participants. The strength of the evidence is insufficient to draw conclusions about the effectiveness or harms of any of the agents studied.

Discussion

Overview

Nine, small, mostly poor quality studies met our review criteria. Studies most frequently addressed sputum volume and pulmonary function measures with no significant between group differences for any agent on any measure of these outcomes. Patient populations varied across studies and included individuals with COPD, bronchitis, asthma, burn injury, as well as mechanically ventilated and postoperative patients. Comparators and outcome measures also varied across studies. Three RCTs used a placebo comparator, and four were crossover studies. Studies typically measured sputum volume or viscosity using different techniques, or measured pulmonary function (FEV1). Participants in studies generally also received standard respiratory care, which may have included other pharmacologic agents, suctioning, or chest physical therapy. Sources of heterogeneity across studies meant that meta-analysis was not appropriate or feasible. The overall body of evidence for any agent on outcomes related to airway clearance is methodologically weak and precludes any conclusions on the effectiveness or harms of the agents studied. In order to supplement the limited harms data reported in these studies, we include an analysis of harms data for the drugs most commonly used (acetylcysteine, ipratropium, and albuterol) reported in the product labeling in Appendix F.

Methodologic Considerations and Limitations

As noted, very few comparative studies addressed mucoactive agents, and we rated only one as good quality for any outcome. Studies typically did not adequately characterize populations, interventions, or methods. Additionally, studies included few patients, and a number used less a less rigorous design (crossover). Participants also received additional airway clearance care, which was often not well- described, and disentangling potential effects is not possible. Studies were typically conducted over 5 years ago (one conducted in 2010, one in 2006, one in 2004, one in the 1990s, one in the 1980s, and four in the 1960s or 1970s), and may not reflect current techniques and best practices in respiratory care. Few studies explicitly addressed harms of agents used.

Future Research

Given the dearth of research of good quality, additional studies of all agents for mucus clearance are needed. The limited number of comparative studies and their limited quality prohibit drawing conclusions from the current body of literature. Future studies should adequately characterize populations, including other interventions that were delivered concurrently with a mucoactive agent, to promote combining of smaller samples and a clear understanding of the potential effects of the study drug. Future research of a new agent should be conducted in adequately powered, randomized controlled trials, using either a placebo comparison or a current best practice agent as a comparator. Additionally, future research should clearly describe methods for randomization, methods for harms assessment, study duration, and any follow-up beyond the immediate study period.

Conclusions

Few comparative studies addressed mucoactive agents to promote airway clearance in hospitalized patients. Those that did were of limited quality and do not permit conclusions about effectiveness. Only two studies reported significant group differences in the outcomes of sputum viscosity and atelectasis. Changes in sputum volume, pulmonary function, and oxygen saturation did not differ significantly between groups in studies of any agent.

References 1. Rogers DF. Mucoactive agents for airway mucus hypersecretory diseases. Respiratory care 2007;52(9):1176-1193; discussion 1193-1177. 2. Balsamo R, Lanata L, Egan CG. Mucoactive drugs. European respiratory review : an official journal of the European Respiratory Society 2010;19(116):127-133. 3. Bhowmik A, Chahal K, Austin G, Chakravorty I. Improving mucociliary clearance in chronic obstructive pulmonary disease. Respiratory medicine 2009;103(4):496-502. 4. Sadowska AM, Verbraecken J, Darquennes K, De Backer WA. Role of N-acetylcysteine in the management of COPD. International journal of chronic obstructive pulmonary disease 2006;1(4):425-434. 5. Rubin BK. The pharmacologic approach to airway clearance: mucoactive agents. Paediatric respiratory reviews 2006;7 Suppl 1:S215-219. 6. Rubin BK. Mucolytics, expectorants, and mucokinetic medications. Respiratory care 2007;52(7):859-865. 7. Ramos FL, Krahnke JS, Kim V. Clinical issues of mucus accumulation in COPD. International journal of chronic obstructive pulmonary disease 2014;9:139-150. 8. Andrews J, Sathe NA, Krishnaswami S, McPheeters ML. Nonpharmacologic airway clearance techniques in hospitalized patients: a systematic review. Respiratory care 2013;58(12):2160- 2186. 9. Flume PA, Robinson KA, O'Sullivan BP, Finder JD, Vender RL, Willey-Courand DB, et al. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respiratory care 2009;54(4):522-537. 10. O'Riordan TG, Mao W, Palmer LB, Chen JJ. Assessing the effects of racemic and single- enantiomer albuterol on airway secretions in long-term intubated patients. Chest 2006;129(1):124-132. 11. Pulle DF, Glass P, Dulfano MJ. A controlled study of the safety and efficacy of acetylcysteine- isoproterenol combination. Current therapeutic research, clinical and experimental 1970;12(8):485-492. 12. Thomas PA, Lynch RE, Merrigan EH. Prevention of postoperative pulmonary atelectasis: review of 215 cases and evaluation of acetycysteine. The American surgeon 1966;32(5):301-307. 13. Desai MH, Mlcak R, Richardson J, Nichols R, Herndon DN. Reduction in mortality in pediatric patients with inhalation injury with aerosolized heparin/N-acetylcystine [correction of acetylcystine] therapy. The Journal of burn care & rehabilitation 1998;19(3):210-212. 14. May CS, Palmer KN. Effect of aerosol ipratropium bromide (SCH 1000) on sputum viscosity and volume in chronic bronchitis. British journal of clinical pharmacology 1977;4(4):491-492. 15. Jepsen S, Klaerke A, Nielsen PH, Nielsen ST, Simonsen O. Systemic administration of N- acetylcysteine has no effect on postoperative lung function following elective upper laparotomy in lung healthy patients. Acta anaesthesiologica Scandinavica 1989;33(3):219-222. 16. Aliyali M, Poorhasan Amiri A, Sharifpoor A, Zalli F. Effects of N-acetylcysteine on asthma exacerbation. Iranian journal of allergy, asthma, and immunology 2010;9(2):103-109. 17. Black PN, Morgan-Day A, McMillan TE, Poole PJ, Young RP. Randomised, controlled trial of N-acetylcysteine for treatment of acute exacerbations of chronic obstructive pulmonary disease [ISRCTN21676344]. BMC pulmonary medicine 2004;4:13.

Appendices

Appendix A. Search Strategies

Table A-1. PubMed Search Strategies Search terms Search results #1 albuterol[mh] OR albuterol[tiab] OR salmeterol[tiab] OR "salmeterol"[nm] OR xopenex[tiab] 117914 OR levalbuterol[tiab] OR formoterol[tiab] OR "formoterol"[nm] OR atrovent[tiab] OR Ipratropium[mh] OR ipratropium[tiab] OR "albuterol-ipratropium"[nm] OR "tiotropium" [nm] OR tiotropium[tiab] OR pulmozyme[tiab] OR mucomyst[tiab] OR DNASE[tiab] OR rhDNase[tiab] OR "DNASE1 protein, human"[nm] OR "dornase alfa"[tiab] OR acetylcysteine[mh] OR acetylcysteine[tiab] OR “acetyl cysteine”[tiab] OR "saline solution, hypertonic"[mh] OR "hypertonic saline"[tiab] OR "sodium bicarbonate"[mh] OR sodium bicarbonate[tiab] OR "guaifenesin"[mh] OR guaifenesin[tiab] OR expectorants[mh] OR mucolytic*[tiab] OR mucoactive[tiab] OR adrenergic beta agonists[mh] OR cholinergic antagonists[mh] OR oxitropium[nm] OR oxitropium[tiab] OR pirbuterol[nm] OR pirbuterol[tiab] OR maxair[tiab] OR glycopyrrolate[mh] OR glycopyrrolate[tiab] OR salbutamol[tiab] OR ((administration, inhalation[mh] OR nebulizers and vaporizers[mh] OR inhaled[tiab] OR nebulized[tiab] OR nebulised[tiab]) AND (heparin[mh] OR tissue plasminogen activator[mh] OR glucocorticoids[mh] OR adrenal cortex hormones[mh] OR sodium chloride[mh] OR epinephrine[mh])) OR racepinephrine[mh] OR mannitol[mh] OR mannitol[tiab] OR sodium channel blockers[mh] OR amiloride[mh] #2 airway obstruction/therapy[mh] OR mucociliary clearance[mh] OR mucus[mh] OR mucus[tiab] 119538 OR "airway clearance"[tiab] OR "airway clearing"[tiab] OR "airway obstruction"[tiab] OR "airflow obstruction"[tiab] OR "lung clearance"[tiab] OR "lung clearing"[tiab] OR "sputum clearance"[tiab] OR "mucus clearance"[tiab] OR "mucous clearance"[tiab] OR "mucous clearing"[tiab] OR "mucociliary clearance"[tiab] OR mucociliary function[tiab] OR "respiratory function"[tiab] OR "pulmonary function"[tiab] OR "lung function"[tiab] OR expectorated volume[tiab] OR sputum[mh] OR sputum[tiab] #3 #1 AND #2 AND English[la] AND humans[mh] 4990 #4 newspaper article[pt] OR letter[pt] OR comment[pt] OR case reports[pt] OR review[pt] OR 5025926 practice guideline[pt] OR news[pt] OR editorial[pt] OR historical article[pt] OR meta- analysis[pt] OR legal cases[pt] OR published erratum[pt] OR congresses[pt] #5 #3 NOT #4 3692 #6 #5 NOT (cystic fibrosis[majr] OR infant, newborn[mh] OR intensive care units, neonatal[mh] 3331 OR newborn[tiab] OR neonatal[tiab])

#7 #6 AND 1970:2014[dp] 3291 Key: [mh] Medical Subject Heading; [tiab] title/abstract word; [pt] publication type; [nm] supplementary concept; [dp] publication date; [la] language

Table A-2. EMBASE search strategy Search terms Search results #1 salbutamol/ or salbutamol sulfate/ or salmeterol/ or salmeterol xinafoate/ or levalbuterol/ or 659446 formoterol fumarate plus mometasone furoate/ or budesonide plus formoterol/ or formoterol/ or beclometasone dipropionate plus formoterol fumarate/ or fluticasone propionate plus formoterol fumarate/ or budesonide plus formoterol fumarate/ or formoterol fumarate/ or ipratropium bromide/ or tiotropium bromide / or oxitropium bromide/ or pirbuterol acetate/ or pirbuterol/ or glycopyrronium bromide/ or amiloride/ or deoxyribonuclease I/ or dornase alfa/ or acetylcysteine/ or bicarbonate/ or guaifenesin/ or exp expectorant agent/ or exp mucolytic agent/ or exp beta adrenergic receptor stimulating agent/ or exp cholinergic receptor blocking agent/ or exp sodium channel blocking agent/ or mannitol/ or ((inhalational drug administration/ or nebulization/ or nebulizer/) and (exp corticosteroid/ or heparin/ or tissue plasminogen activator/ or sodium chloride/)) #2 exp obstructive airway disease/th, dt, su or mucociliary clearance/ or mucus/ or sputum/ 119911

A-1

#3 #1 AND #2 35662 #4 Limit #3 to (human and english language and exclude medline journals) 2469 #5 (review or conference paper or editorial or letter or note or short survey).pt. or case report/ or 6564552 pracice guideline/ or "systematic review"/ or meta analysis/ #6 #4 not #5 874 Key: .pt publication type; th, dt, su therapy subheadings; exp explode to narrower subject terms Note: EMBASE includes literature from 1974 – present

A-2

Appendix B. Screening Forms

Abstract Review Form

1. Study is original research (prospective or retrospective clinical studies, systematic reviews and meta- analyses).

Yes No Cannot Determine If answer to question 1 is NO, this form is complete. Submit the form to move to the next reference.

2. Includes a population of interest (hospitalized patients/ patients with neuromuscular disease or respiratory muscle weakness/ post-operative patients receiving pharmacologic agent of interest to promote airway clearance; all without cystic fibrosis and over 1 year of age ).

Yes No Cannot Determine

3. Includes an agent of interest (albuterol sulfate, salmeterol, xopenex, formoterol, salbutamol, pirbuterol, ipratropium bromide, oxitropium bromide, glycopyrrolate, tiotropium bromide, N-acetylcysteine (avoid studies that indicate this medication used for Tylenol overdose), dornase alfa, sodium bicarbonate, hypertonic saline, guiafenesin, normal saline, inhaled heparin, inhaled TPA, racemic epinephrine, amiloride, mannitol).

Yes No Cannot Determine

4. Addresses an outcome of interest (change in sputum properties, oxygenation, ventilator time, LOS in hospital or ICU, readmission/ED admission, respiratory mechanics, pulmonary function, harms/complications of pharmacologic agent, quality of life, incidence of infection).

Yes No Cannot Determine

5. Study setting is inpatient/hospital.

Yes No Cannot Determine

6. If excluded, retain for review of references?

Yes No Cannot determine

7. Comments:

B-1

Full Text Review Form

REFID: ______Reviewer initials: ______1. Is the study original research or a systematic review or meta-analysis? Yes No (Exclude editorials, commentaries, letters to editor, etc.)

2. Includes one of the following non-cystic fibrosis populations of > 1 year of age receiving a pharmacologic agent to promote airway clearance:

2a. Hospitalized or postoperative patients Yes No 2b. Patients with neuromuscular disease or respiratory muscle weakness 2c. Patients with impaired cough

3. Study addresses a pharmacologic agent of interest used to promote mucus clearance (albuterol sulfate, salmeterol, xopenex, formoterol, salbutamol, pirbuterol, ipratropium bromide, oxitropium bromide, glycopyrrolate, tiotropium bromide, N-acetylcysteine (avoid studies that indicate this Yes No medication used for Tylenol overdose), dornase alfa, sodium bicarbonate, hypertonic saline, guiafenesin, normal saline, inhaled heparin, inhaled TPA, racemic epinephrine, amiloride, mannitol).

4. Study includes an intervention group and a comparison group Yes No

5. Study reports outcomes related to effects of intervention on Select outcome: mucus clearance __Change in sputum properties/sputum clearance __Harms/complications of pharmacologic agent __Incidence of infection __LOS in hospital or ICU __Oxygenation __Pulmonary function __Quality of life __Readmission/ED admission __Respiratory mechanics __Ventilator time __No outcomes of interest

6. Setting is hospital/inpatient Yes No

Comments:

B-2

Appendix C. Evidence Tables Intervention(s)/ Study Description Patient Population Outcomes (definition) and Effect Comparator(s) Author: Intervention: N- Description of population: Those Fifth day of hospitalization: Aliyali et al., 2010 16 acetylcysteine (NAC) 600 mg with asthma exacerbation Dyspnea score b.d. during 5 days of G1: 0.84±1.06 Country: Iran hospitalization given in Baseline measures comparable G2: 0.91±1.01, p=0.798 addition to usual medication between groups: Yes Intervention setting: within 24 hours of admission. Wheezing score Pulmonary ward of a initial stabilization by Age, mean years ± SD: G1: 0.84±0.94 Teaching hospital administering short acting ß2 G1: 50 ± 15.74 G2: 0.87±0.79, p=0.889 agonist and/or anticholinergic G2: 47.8 ± 12.06 bronchodilators, and Cough score Study Design: parenteral corticosteroid Underlying condition(s): Subjects G1: 0.72±0.84 RCT (single blinded, with physician diagnosed asthma G2: 0.79±0.97, p=0.784 placebo controlled) Comparator: Placebo Mechanical ventilation: Sputum score Groups/n: G1: n=0 G1: 0.79±0.83 G1: NAC/25 G2: n=1 G2: 0.62±0.71, p=0.460 G2: Placebo /25 Expectoration score

Followup: Immediate G1: 0.79±0.97 G2: 0.83±1.09, p=0.890 % available at follow-up: G1: 100 (n=25) Night sleep score G2: 96 (n=24) G1: 0.68 ± 0.98 G2: 1 ± 1.17, p=0.308

Morning PEFR (peak flow meter) G1: 282±94.86 G2: 256.95±96.36, p=0.369

No significant differences were found in any of the outcome measures on day 1 also (p>0.05)

C-1

Intervention(s)/ Study Description Patient Population Outcomes (definition) and Effect Comparator(s) Author: Intervention: Following the Description of population: Aspirate volume, ml: O’Riordan et al., 200610 washout period of 2 weeks, no Tracheostomized patients receiving 5 day aggregate of the first –hour volume nebulized treatment during the long term mechanical ventilation Mean ± SEM Country: US 1st week. (control group) G1a: 9.33 ± 2.91 Patients then randomized in Baseline measures comparable G1b: 9.50 ± 2.39 Intervention setting: crossover manner to each of 3 between groups: Yes G1c:12.46 ± 4.23 Long-term ventilator nebulized treatments: normal Rx volumes on the 1st day greater than on the unit in a nursing facility saline solution (3ml), generic Age, median years (range): subsequent 4 days when measured at 1 hour racemic albuterol (2.5 G1a/G1b/G1c/G1d: 72 (35-93) (p=0.014) mg/3ml), and R-albuterol Study Design: (1.25 mg/3ml). Each Rx Underlying condition(s),n: 5 day aggregate after 4 hours volume: RCT- Placebo- administered 3 times daily for COPD: 6 G1a: 25.08 ± 5.50 controlled crossover 5 days. Idiopathic pulmonary fibrosis: 1 G1b: 24.93 ± 4.85 Amyotrophic lateral sclerosis: 2 G1c: 26.92 ± 6.79 Neuropathy: 2 No differential effect for aspirate volume obtained

Groups, n=17: Myopathy: 2 at 5 days (p=0.84) or measured on daily basis

G1a: Saline solution Encephalopathy: 1 G1b: Generic Racemic Inflammatory parameters, ng/ml albuterol Mechanical ventilation, n: sICAM: G1c: R-Albuterol 24-h :11 G1a: 225.72 ± 97.72 G1d: Control (baseline) Nocturnal: 1 G1b:177.94 ± 95.14 Humidified tracheostomy collar only: G1c: 213.09 ± 111.47 2 Followup: Immediate IL-1beta: G1a: 20.69 ± 7.78 % available at follow-up: G1b: 26.61 ± 7.64 G1a/G1b/G1c/G1d: 82.4 G1c: 20.38 ± 5.85 (n=14) IL-8: G1a: 699.39 ± 185.86 G1b: 695.29 ± 178.92 G1c: 597.55 ± 157.14

TNF alpha: G1a: 1.84 ± 0.54 G1b: 1.52 ± 0.42 G1c: 1.60 ± 0.45 mean data for inflammatory indexes, no significant treatment differences (p>0.05)

Harms: None due to study medication noted

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Intervention(s)/ Study Description Patient Population Outcomes (definition) and Effect Comparator(s) Author: Intervention: Description of population: Acute Absolute change in scores: Black et al., 2004 17 N-aceytyl Cysteine (NAC) 600 exacerbation of COPD in hospitalized Breathlessness (Likert Score) mg, twice daily for 7 days or patients with a smoking history of ≥ G1: 0.7 Country: New Zealand until discharge 10 pack years and aged ≥ 50 years G2: 0.8 (p=ns)

Intervention setting: Comparator: Placebo Baseline measures comparable FEV1 (litres) Hospital between groups: Yes G1: 0.03 All subjects received G2: 0.15 (p=ns) concurrent treatment with Age, mean years ± SD: Study Design: RCT oxygen therapy, prednisone G1: 73.6 ± 7.8 SaO2 (%): 40 mg/day, nebulised G2: 73.0 ± 8.2 G1: 1.2 salbutamol 5 mg G2: 1.8 (p=ns) q.i.d, ipratropium 0.5 mg q.i.d. Underlying condition(s): COPD and where appropriate Length of hospital stay (median days) antibiotics Mechanical ventilation: NR G1: 6 G2: 5.5 (p=ns) Groups/n: G1: NAC / 25 Harms: G2: Placebo / 25 Nausea G1: n=1 Followup: 2 hours after the G2: n=2 last dose of nebulised No serious adverse events reported Bronchodilator

% available at follow-up: G1: 100 G2: 100

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Intervention(s)/ Study Description Patient Population Outcomes (definition) and Effect Comparator(s) Author: Intervention: 5000 units of Description of population: Pediatric Ventilator days (hrs), mean ± SD: Desai et al., 1998 13 aerosolized heparin patients requiring ventilator support G1: 81 ± 93 alternating with 3 ml of a 20% G2: 187 ± 79, p=NR Country: USA solution of acetylcysteine Baseline measures comparable every 2 hours for the first 7 between groups: age, BSA Reintubation incidence rate, % Intervention setting: days after injury comparable G1: 6 (3/47) Hospital admissions G2: 28 (12/43), p<0.05 Comparator: Control Age, mean years ± SD: G1: 7.7 ± 5 Mortality, % Study Design: Both groups received G2: 8.2 ± 6 G1: 4 (2/47) Retrospective cohort standard inhalation injury G2: 19 (8/43), p<0.05 protocol Underlying condition(s): Massive burn injury & bronchoscopically Incidence of atelectasis, % Groups/n: diagnosed inhalation injury G1: 42 (20/47) G1: Aerosolized Heparin + G2: 69 (30/43), p<0.05 acetylcysteine / 47 Mechanical ventilation: 100% G2: controls / 43

Followup: Immediate

% available at follow-up: G1: 100 G2: 100

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Intervention(s)/ Study Description Patient Population Outcomes (definition) and Effect Comparator(s) Author: Intervention: Description of population: adults Difference in Actual and preoperative alveolo- 15 Jepsen et al., 1989 1200 mg N-acetylcysteine with healthy lungs undergoing arterial oxygen difference (P(A-a)O2), median (NAC) daily (either 400 mg 3 elective upper laparotomy % (interquartile range): Country: Denmark times/day or 600 mg 2 Day 5: times/day) or placebo by Baseline measures comparable G1: 6.5 (1.0 – 15.4) Intervention setting: mouth the day before surgery, between groups: Yes G2: 7.9 (0.4 – 15.2) Hospital followed by 200 mg NAC or p=NS placebo by IV on induction of Age, mean years: Study Design: RCT anesthesia; 200mg G1: 56.1 Relative decrease in FEV in 1 s, preoperative – NAC/placebo administered 3 G2: 50.7 actual FEV1 x 100/preoperative FEV1, median times daily (by IV until bowel % (interquartile range) function resumed, then by Underlying condition(s): Day 6 mouth) for 6 days or until Smokers, %: G1: 21.4 (8.9 – 37.2) discharge G1: 55 G2: 26.4 (10.4 – 36.7) G2: 49 p=NS Comparator: Placebo Minor surgery, %: Relative decrease in vital capacity, Groups/n: G1: 55 preoperative – actual VC x 100/preoperative G1: NAC /64 G2: 61 VC, median % (interquartile range) G2: Placebo /67 G1: 17.9 (3.8 – 31.2) Major surgery, %: G2: 23.8 (12.6 – 32.5) Followup: G1: 45 p=NS Day 1: G2: 39 G1: 62 Atelectasis at day 4, %: G2: 67 Overweight, %: Grade A (no atelectasis): G1: 44 G1: 50.0 Day 3: G2: 31 G2: 53.4 G1: 55 G2: 62 Mechanical ventilation: NR Grade B (1 subsegmental): G1: 13.0 Day 5 G2: 23.3 G1: 37 G2: 43 Grade C (2 subsegmental): G1: 14.8 % available at follow-up G2: 10.0 (day 5): G1: 58 Grade D (>2 subsegmental or lobular): G2: 64 G1: 22.2 G2: 13.3

Total (B+C+D) G1: 50 (n=54)

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Intervention(s)/ Study Description Patient Population Outcomes (definition) and Effect Comparator(s) G2: 46.6 (n=60) G1 vs. G2: p=NS

No side-effects due to medication recorded

No significant effect modification or confounding by smoking status, overweight, type of operation, or reduction of preoperative VC or FEV1

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Study Description Intervention(s)/ Comparator(s) Patient Population Outcomes (definition) and Effect Author: Intervention: G1a: 2 puffs of Description of population: Mean Change 14 -1 May et al., 1977 ipratropium bromide (40 mcg) in hospitalized patients with chronic Sputum viscosity at 700 s (centipoise), 24 hours bronchitis mean ± SD: Country: UK G1a: 91.6 ± 44.3 Comparator: G1b: placebo in Baseline measures comparable G1b: 73.0 ± 29.6 Intervention setting: 24 hours between groups: Yes (crossover p=NS Academic hospital trial) Groups/n: 24 hour sputum volume, mean ml ± SD: Study Design: G1: 12 Age, mean years ± SD: NR G1a: 33.3 ± 19.7 Randomized crossover G1a: 12 G1b: 34.0 ± 20.4 trial G1b: 12 Underlying condition(s): p=ns Bronchitis patients producing mucoid Followup: 2 days total sputum

% available at follow-up: Mechanical ventilation: NR G1: 100

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Intervention(s)/ Study Description Patient Population Outcomes (definition) and Effect Comparator(s) Author: Intervention: Description of population: Sputum Volume, cc: Pulle et al., 1970 11 G1a: Control therapy: 1st Hospitalized Male patients included Mean ± SD: week, patients received after acute respiratory G1a: 37.1 ± 25.3 Country: US conventional respiratory decompensation had subsided G1b: 34.2 ± 19.9 treatment (10 drops of G1c: 30.3 ± 18.8 Intervention setting: Isoproterenol 4cc for 15 Baseline measures comparable G1a/G1b/G1c: pairwise comparison p=ns Hospital minutes 3 times daily) along between groups: yes with individualized medication Sputum volume increased, n (%): Study Design: and no expectorants, Age, range years ± SD: G1b: 10 (50) RCT-crossover mucolytics, or aerosol G1a/G1b/G1c: 47-73 G1c: 5 (25) humidification Underlying condition(s): Patients Sputum volume same, n (%): G1b: Mixture of 10% of with Chronic bronchitis and asthmatic G1b, G1c: 2(10) Acetylcysteine + 0.05% of bronchitis isoproterenol, 4cc 3 times Sputum volume Decreased, n (%): daily administered by Mechanical ventilation: NR G1b: 8 (40) intermittent positive pressure G1c: 13 (65) breathing nebulization, in addition to individualized Sputum Viscosity, cps: medication Mean ± SD: G1a: 10033 ± 4662 G1c: Placebo which included G1b: 6742 ± 3254 0.9%saline+0.5% G1c: 10310 ± 5238 Acetylcysteine+0.05% G1a vs. G1b, p<0.01 Isoproterenol , 4 cc 3 times G1b vs. G1c, p<0.01 daily along with control therapy Sputum viscosity –Thinner, n (%) G1b: 16 (80) Duration: 3 weeks (3 periods G1c: 8 (40) of 1 week each) No change, n (%): Groups/n: G1b: 2 (10) G1a/G1b/G1c: 20 G1c: 1 (5)

Followup: Immediate Thicker, n (%): G1b: 2 (10) % available at follow-up: G1c: 11 (55) G1a/G1b/G1c:100 FEV1 , L: G1a: 1.61 ± 0.89 G1b: 1.66 ± 0.83 G1c: 1.69 ± 0.87

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Intervention(s)/ Study Description Patient Population Outcomes (definition) and Effect Comparator(s) G1a/G1b/G1c: pairwise comparison p=ns

FVC, L: G1a: 2.85 ± 0.86 G1b: 3.08 ± 0.88 G1c: 3.01 ± 0.88 G1a/G1b/G1c: pairwise comparison p=ns

MVV, L/min: G1a: 45.65 ± 26.54 G1b: 46.70 ± 21.35 G1c: 47.40 ± 23.27 G1a/G1b/G1c: pairwise comparison p=ns

Harms: No bronchospasm or other adverse reaction observed

** Subjective measure data not extracted

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Study Description Intervention(s)/ Comparator(s) Patient Population Outcomes (definition) and Effect Author: Intervention: Intratracheal Description of population: Atelectasis Thomas et al., 1966 12 administration of 10 % solution of Patients undergoing different types of G1: 2/20 (10%) N-Acetyl-Lcysteine (NAC) given abdominal surgeries and being G2: 9/20 (45%) Experiment 1 2ml / every 2hours for 10 doses observed for incidence of atelectasis p=NR after recovery from anesthesia after surgery Country: USA for abdominal surgery Baseline measures comparable Intervention setting: Comparator: Physiologic Saline between groups: NR Post-operative ward (2ml) given every 2 hours Age, mean years ± SD: Groups/n: G1/G2: NR Study Design: RCT G1: NAC/20 G2: Saline/20 Underlying condition(s): abdominal surgery Followup: Postoperative period day1 & day2 Mechanical ventilation: NR

% available at follow-up: G1: 100 G2: 100

Note: harms reported in the paper reporting separate experiments include nausea and decreased appetite. The study does not clearly report in which group(s) of patients these harms occurred nor in how many patients.

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Intervention(s)/ Study Description Patient Population Outcomes (definition) and Effect Comparator(s) Author: Intervention: Intratracheal Description of population: Atelectasis Thomas et al., 1966 12 administration of 10 % Patients undergoing different types of G1: 4/20 (20%) solution of N-Acetyl-L- abdominal surgeries and being G2: 4/20 (20%) Experiment 2 cysteine (NAC) given 2ml / observed for incidence of atelectasis every 2hours for 10 doses after surgery Country: USA after recovery from anesthesia for abdominal surgery Baseline measures comparable Intervention setting: between groups: NR Post-operative ward Comparator: Intermittent positive pressure device – Age, mean years ± SD: administered 10 % solution of G1/G2: NR Study Design: RCT NAC given 2ml / every 2hours for 10 doses after recovery Underlying condition(s): abdominal from anesthesia for abdominal surgery surgery Mechanical ventilation: NR Groups/n: G1: Intratracheal NAC/20 G2: Intermittent positive pressure NAC/20

Followup: Postoperative period day1 & day2

% available at follow-up: G1: 100 G2: 100 Note: harms reported in the paper reporting separate experiments include nausea and decreased appetite. The study does not clearly report in which group(s) of patients these harms occurred nor in how many patients.

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Evidence Table References 10. O'Riordan TG, Mao W, Palmer LB, Chen JJ. Assessing the effects of racemic and single-enantiomer albuterol on airway secretions in long-term intubated patients. Chest 2006;129(1):124-132. 11. Pulle DF, Glass P, Dulfano MJ. A controlled study of the safety and efficacy of acetylcysteine-isoproterenol combination. Current therapeutic research, clinical and experimental 1970;12(8):485-492. 12. Thomas PA, Lynch RE, Merrigan EH. Prevention of postoperative pulmonary atelectasis: review of 215 cases and evaluation of acetycysteine. The American surgeon 1966;32(5):301-307. 13. Desai MH, Mlcak R, Richardson J, Nichols R, Herndon DN. Reduction in mortality in pediatric patients with inhalation injury with aerosolized heparin/N-acetylcystine [correction of acetylcystine] therapy. The Journal of burn care & rehabilitation 1998;19(3):210-212. 14. May CS, Palmer KN. Effect of aerosol ipratropium bromide (SCH 1000) on sputum viscosity and volume in chronic bronchitis. British journal of clinical pharmacology 1977;4(4):491-492. 15. Jepsen S, Klaerke A, Nielsen PH, Nielsen ST, Simonsen O. Systemic administration of N-acetylcysteine has no effect on postoperative lung function following elective upper laparotomy in lung healthy patients. Acta anaesthesiologica Scandinavica 1989;33(3):219-222. 16. Aliyali M, Poorhasan Amiri A, Sharifpoor A, Zalli F. Effects of N-acetylcysteine on asthma exacerbation. Iranian journal of allergy, asthma, and immunology 2010;9(2):103-109. 17. Black PN, Morgan-Day A, McMillan TE, Poole PJ, Young RP. Randomised, controlled trial of N-acetylcysteine for treatment of acute exacerbations of chronic obstructive pulmonary disease [ISRCTN21676344]. BMC pulmonary medicine 2004;4:13.

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Appendix D. Excluded Studies

Exclusion reasons X-1 Not original research X-2 Not a population of interest X-3 Not an intervention of interest X-4 Not an outcome of interest X-5 Not a comparative study X-6 Not in hospitalized setting X-7 Not in English or not obtainable

1. Webb WR. Clinical evaluaton of a new mucolytic agent, acetyl-cysteine. The Journal of thoracic and cardiovascular surgery 1962;44:330-343. X-2, X-4, X-5, X-6 2. Bernstein IL, Ausdenmoore RW. IATROGENIC BRONCHOSPASM OCCURRING DURING CLINICAL TRIALS OF A NEW MUCOLYTIC AGENT, ACETYLCYSTEINE. Diseases of the chest 1964;46:469-473. X-1 3. Poppe JK. CLINICAL EXPERIENCES WITH ACETYLCYSTEINE AS A MUCOLYTIC AGENT. Diseases of the chest 1964;46:66-69. X-1, X-5 4. Sheffner AL, Medler EM, Jacobs LW, Sarett HP. THE IN VITRO REDUCTION IN VISCOSITY OF HUMAN TRACHEOBRONCHIAL SECRETIONS BY ACETYLCYSTEINE. The American review of respiratory disease 1964;90:721-729. X-1, X-2 5. Lawson D, Saggers BA. N.A.C. AND ANTIBIOTICS IN CYSTIC FIBROSIS. British medical journal 1965;1(5430):317. X-1 6. Hirsch SR, Kory RC. An evaluation of the effect of nebulized N-acetylcysteine on sputum consistency. The Journal of allergy 1967;39(5):265-273. X-2, X-6 7. Hurst GA, Shaw PB, LeMaistre CA. Laboratory and clinical evaluation of the mucolytic properties of acetylcysteine. The American review of respiratory disease 1967;96(5):962-970. X-1, X-2, X-4, X-5, X- 6 8. Bruce RA, Kumar V. The effect of a derivative of vasicine on bronchial mucus. The British journal of clinical practice 1968;22(7):289-292. X-1, X-3 9. Kory RC, Hirsch SR, Giraldo J. Nebulization of N-acetylcysteine combined with a bronchodilator in patients with chronic bronchitis. A controlled study. Diseases of the chest 1968;54(6):504-509. X-6 10. Dulfano MJ, Glass P. An effective mucolytic aerosol in chronic bronchitis. JAMA : the journal of the American Medical Association 1969;207(7):1310-1314. X-6 11. Christensen F, Kjer J, Ryskjaer S, Arseth-Hansen P. Bromhexine in chronic bronchitis. British medical journal 1970;4(5727):117. X-2, X-3, X-4, X-6 12. Hamilton WF, Palmer KN, Gent M. Expectorant action of bromhexine in chronic obstructive bronchitis. British medical journal 1970;3(5717):260-261. X-3 13. Holley HS. Humidification and mist therapy in chronic obstructive lung disease. International anesthesiology clinics 1970;8(3):617-635. X-1, X-3 14. Langlands JH. Double-blind clinical trial of bromhexine as a mucolytic drug in chronic bronchitis. Lancet 1970;1(7644):448-450. X-3 15. Lieberman J. The appropriate use of mucolytic agents. The American journal of medicine 1970;49(1):1-4. X-1, X-2, X-3, X-4, X-5, X-6 16. Muskovitch ZF. Mucomyst. Annals of allergy 1970;28(3):121-122. X-1, X-2, X-3, X-4, X-5, X-6 17. Palmer KN, Hamilton WF. Expectorant properties of bromhexine. Lancet 1970;1(7646):563. X-1, X-2, X-3, X-4, X-5, X-6 18. Palmer KN, Legge JS, Hamilton WF, Diament ML. Comparison of effect of salbutamol and isoprenaline on spirometry and blood-gas tensions in bronchial asthma. British medical journal 1970;2(5700):23-24. X- 1 19. Polk JW, Medina M. A comparative study of alevaire and a new mucolytic agent, acumist in postoperative patients. Eye, ear, nose & throat monthly 1970;49(7):321-324. X-2

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20. Procter DF, Boyd EM. Nutmeg oil and camphene as inhaled expectorants. Archives of otolaryngology (Chicago, Ill : 1960) 1970;92(4):411-412. X-1, X-2, X-3, X-4, X-5, X-6 21. Ramirez J, O'Neill EF. Endobronchial Polymyxin B: experimental observations in chronic bronchitis. Chest 1970;58(4):352-357. X-1, X-2, X-3, X-4, X-5, X-6 22. Mucolytic agents. British medical journal 1971;2(5761):581-582. X-1, X-2, X-3, X-4, X-5, X-6 23. Bromhexine. Lancet 1971;1(7708):1058. X-1, X-2, X-3, X-4, X-5, X-6 24. Bateman PP. A new mucolytic, bromhexine ("bisolvon"). A double-blind study. The Medical journal of Australia 1971;1(18):963-965. X-2, X-3, X-4, X-5, X-6 25. Benjamin C. The use and efficacy of mucolytic agents. South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde 1971;45(34):948-952. X-2, X-5, X-6 26. Christensen SB, Kjer J, Ryskjaer S, Arseth-Hansen P, Christensen F. Mucolytic treatment of chronic bronchitis during two winter periods. Scandinavian journal of respiratory diseases 1971;52(1):48-57. X- 2, X-3, X-6 27. Cobbin DM, Elliott FM, Rebuck AS. The mucolytic agent bromhexine (bisolvon) in chronic lung disease. A double-blind crossover trial. Australian and New Zealand journal of medicine 1971;1(2):137-140. X-2, X-3, X-4, X-5, X-6 28. Condie R. An assessment in general practice of bromhexine in the treatment of chronic bronchitis. The Practitioner 1971;207(241):672-676. X-1, X-2, X-3, X-4, X-5, X-6 29. Harrison BD, Srivongse SA, Collins JV. The effects of salbutamol on pulmonary and systemic haemodynamics. Guy's Hospital reports 1971;120(1):17-23. X-1, X-2, X-3, X-4, X-5, X-6 30. Husen L, Fulkerson LL, Del Vecchio E, Zack MB, Stein E. Pulmonary tuberculosis with negative findings on chest x-ray films: a study of 40 cases. Chest 1971;60(6):540-542. X-2, X-3, X-4, X-5, X-6 31. Lightowler JE, Lightowler NM. Comparative mucolytic studies on dithiothreitol, N-acetyl-cysteine and L- cysteine on human respiratory mucus in vitro and their effects on the rate of flow of mucus in the exposed trachea of the rat on topical application. Archives internationales de pharmacodynamie et de therapie 1971;189(1):53-58. X-7 32. Paez PN, Miller WF. Surface active agents in sputum evacuation: a blind comparison with normal saline solution and distilled water. Chest 1971;60(4):312-317. X-2, X-6 33. Prime FJ, Kamburoff PL, Gunthner W. Comparison of the bronchodilatory action of two drugs. Internationale Zeitschrift fur klinische Pharmakologie, Therapie, und Toxikologie International journal of clinical pharmacology, therapy, and toxicology 1971;5(3):293-296. X-2, X-3, X-4, X-6 34. Vale JR. Oral salbutamol as a supplement too inhaled aerosol in obstructive respiratory disease. Scandinavian journal of respiratory diseases 1971;52(1):58-62. X-1, X-2, X-3, X-4, X-5, X-6 35. Valic F, Zuskin E. Effects of hemp dust exposure on nonsmoking female textile workers. Archives of environmental health 1971;23(5):359-364. X-1, X-2, X-3, X-4, X-5, X-6 36. Respiratory failure. British medical journal 1972;1(5793):170-172. X-1, X-2, X-3, X-4, X-5, X-6 37. Alexander E, Jr. Medical management of closed head injuries. Clinical neurosurgery 1972;19:240-250. X- 1, X-2, X-3, X-4 38. Alliott RJ, Lang BD, Rawson DR, Leckie WJ. Effects of salbutamol and isoprenaline-phenylephrine in reversible airways obstruction. British medical journal 1972;1(5799):539-542. X-1 39. Bach PH, Leary WP. The effects of bromhexine on oxytetracycline penetrance into sputum. South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde 1972;46(41):1512-1514. X-2, X-3, X-4, X-6 40. Bonime RG. Improved procedure for the preparation of pulmonary cytology smears. Acta cytologica 1972;16(6):543-545. X-1 41. Brogan TD, Allen L, Hutt H, Ryley HC. Effect of bromhexine therapy on concentrations of oxytetracycline in the sol phase of sputum. The British journal of clinical practice 1972;26(12):555-558. X-7 42. Clarke SW, Craig GM, Makin EJ. Clinical trial of bromhexine in severe chronic bronchitics during winter. Thorax 1972;27(4):429-432. X-2, X-3, X-6 43. Cohen BM. Ultrasonic nebulization of water and mucoevacuant solutions in patients with obstructive lung disease: volumetric and ventilatory responses to acute administration. Respiration; international review of thoracic diseases 1972;29(1):51-60. X-3, X-6 44. Lal S, Harris DM, Bhalla KK, Singhal SN, Butler AG. Comparison of beclomethasone dipropionate aerosol and prednisolone in reversible airways obstruction. British medical journal 1972;3(5822):314-317. X-1, X-2, X-3

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45. Macdonald J. Liquefaction of sputum by N-acetyl-l-cysteine and dithiothreitol. Canadian journal of medical technology 1972;34(6):204-217. X-1, X-2, X-3, X-4, X-5, X-6 46. Milledge JS, Benjamin S. Arterial desaturation after sodium bicarbonate therapy in bronchial asthma. The American review of respiratory disease 1972;105(1):126-128. X-2, X-3, X-4, X-5, X-6 47. Offermeier J, Miller R, Brandt HD. The effect of bromhexine on the concentration of oxytetracycline in nasal mucus. South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde 1972;46(41):1509-1511. X-1, X-4 48. Reep BR, Kaplan W. The effect of newer tubercle bacillus digestion and decontamination procedures on fungi causing pulmonary diseases. Mycopathologia et mycologia applicata 1972;46(4):325-334. X-1 49. Reep BR, Kaplan W. The use of N-acetyl-L-cysteine and dithiothreitol to process sputa for mycological and fluorescent antibody examinations. Health laboratory science 1972;9(2):118-124. X-1, X-2, X-3, X- 4, X-5, X-6 50. Rubin P, Block AJ. Nonspecific lung abscess. A perspective. Geriatrics 1972;27(2):125-136. X-1 51. Schonell M, Chan-Yeung M, McLean L. Salbutamol--an effective bronchodilator. Canadian Medical Association journal 1972;106(4):339-341. X-1 52. Simonsson BG, Stiksa J, Strom B. Double-blind trial with increasing doses of salbutamol and terbutaline aerosols in patients with reversible airways obstruction. Acta medica Scandinavica 1972;192(5):371-376. X-2, X-3, X-4, X-6 53. Thompson KJ, Reeve J. A clinical trial of bromhexine. The New Zealand medical journal 1972;76(483):73-76. X-1, X-2, X-3, X-4, X-5, X-6 54. Waddell WR, Taubman J. Mechanical and chemical methods of opening occluded T tubes. Surgery 1972;71(1):91-96. X-1, X-2, X-3, X-4, X-5, X-6 55. A controlled trial of the effects of bromhexine on the symptoms of out-patients with chronic bronchitis. A report to the Research Committee of the British Thoracic and Tuberculosis Association. British journal of diseases of the chest 1973;67(1):49-60. X-1 56. Aylward M. A between-patient, double-blind comparison of S-carboxymethylcysteine and bromhexine in chronic obstructive bronchitis. Current medical research and opinion 1973;1(4):219-227. X-2, X-3, X-6 57. Barton AD, Powers JL, Lopata M, Lourenco RV. Biochemical characteristics affecting the consistency of bronchial secretions. Chest 1973;63:Suppl:59S-62S. X-1 58. Brechter C. Clinical trial with terbutaline and guajacol. Scandinavian journal of respiratory diseases 1973;54(2):78-82. X-1, X-2, X-3, X-4, X-5, X-6 59. Chodosh S, Medici TC. Letter: Expectorant effect of glyceryl guiacolate. Chest 1973;64(4):543-545. X-1 60. Cochrane GM, Clark TJ, Hanan ME. The role of oral bronchodilator therapy as shown by a comparison between salbutamol and terbutaline. Current medical research and opinion 1973;1(9):517-523. X-2, X-3, X-4 61. Dulfano MJ, Glass P. Evaluation of a new B 2 adrenergic receptor stimulant, terbutaline, in bronchial asthma. II. Oral comparison with ephedrine. Current therapeutic research, clinical and experimental 1973;15(4):150-157. X-1 62. Epstein SW, Barnard JA, Zsoter TT. A clinical trial of long-term oral salbutamol in reversible diffuse airway obstruction. The American review of respiratory disease 1973;108(6):1367-1372. X-1 63. Glass P, Dulfano MJ. Evaluation of a new B 2 adrenergic receptor stimulant, terbutaline, in bronchial asthma. I. Subcutaneous comparison with epinephrine. Current therapeutic research, clinical and experimental 1973;15(4):141-149. X-1 64. Grassi C, Morandini GC, Frigerio G. Clinical evaluation of systemic acetylcysteine by different routes of administration. Current therapeutic research, clinical and experimental 1973;15(4):165-179. X-1 65. Grater WC, Cato A. Double-blind study of acetylcysteine-isoproterenol and saline-isoproterenol in non- hospitalized patients with asthma. Current therapeutic research, clinical and experimental 1973;15(9):660- 671. X-1, X-2, X-6 66. Harris L. Comparison of cardiorespiratory effects of terbutaline and salbutamol aerosols in patients with reversible airways obstruction. Thorax 1973;28(5):592-595. X-2, X-3, X-4, X-6 67. Hirsch SR, Viernes PF, Kory RC. The expectorant effect of glyceryl guaiacolate in patients with chronic bronchitis. A controlled in vitro and in vivo study. Chest 1973;63(1):9-14. X-3 68. Hudson LD, Tyler ML, Petty TL. Oral aminophylline and dikydroxypropyl theophylline in reversible obstructive airway disease: a single-dose, double-blind, crossover comparison. Current Therapeutic Research, Clinical & Experimental 1973;15(7):367-372. X-1

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69. Mattila MJ, Alanko K. Objective assessment of a bronchodilator drug combination in asthmatic outpatients. Current therapeutic research, clinical and experimental 1973;15(6):273-284. X-1 70. McLeod J, Selman J. A comparison of Berotec (Th1165a) and Salbutamol aerosols. The New Zealand medical journal 1973;78(498):209-210. X-1, X-2, X-3, X-4, X-5, X-6 71. Mercer R, Mercer S, Morton A. A trial of salbutamol in an intensive therapy unit. The Australian and New Zealand journal of surgery 1973;42(3):300-301. X-2, X-3, X-4, X-5 72. Poppius H, Salorinne Y. Comparative trial of a new anticholinergic bronchodilator, Sch 1000, and salbutamol in chronic bronchitis. British medical journal 1973;4(5885):134-136. X-1, X-5 73. Thomson ML, Pavia D, McNicol MW. A preliminary study of the effect of guaiphenesin on mucociliary clearance from the human lung. Thorax 1973;28(6):742-747. X-6 74. Zsoter TT, Epstein SW. Effect of salbutamol on the peripheral circulation in man. Chest 1973;64(4):465- 471. X-1 75. Andreasen T. Mucolytic treatment of chronic bronchitis during two winter periods. Scandinavian journal of respiratory diseases Supplementum 1974;90:69-70. X-1, X-2, X-3, X-6 76. Burgi H. Changes in the fibre system and viscosity of the sputum of bronchitis during treatment with bromhexine and guaiphenesin (guaiacol glyceryl ether). Scandinavian journal of respiratory diseases Supplementum 1974;90:81-85. X-2, X-6 77. Camner P, Strandberg K, Philipson K. Increased mucociliary transport by cholinergic stimulation. Archives of Environmental Health: An International Journal 1974;29(4):220-224. X-1 78. Caponegro PJ, Leadbetter GW, Jr. Acute ureteral obstruction secondary to mucoid impaction in supravesical diversion. Treatment with N-acetylcysteine. Urology 1974;3(4):486-487. X-1, X-2, X-4 79. Harris L. Comparison of cardiorespiratory effects of rimiterol and terbutaline aerosols. Bulletin de physiopathologie respiratoire 1974;10(6):801-810. X-1, X-2, X-3, X-4, X-5, X-6 80. Heisinger DH. Letter: Racemic epinephrine in croup. Pediatrics 1974;53(2):290. X-1, X-2, X-3, X-4, X- 5, X-6 81. Keal E. Criteria for the testing of mucolytic agents. Scandinavian journal of respiratory diseases Supplementum 1974;90:49-53. X-1, X-2, X-3, X-4, X-5, X-6 82. Lahdensuo A, Alanko K, Poppins H, Harkonen M. A comparative study of the efficacy of inhaled beclomethasone and systemic prednisolone in bronchial asthma. Scandinavian journal of respiratory diseases 1974;55(6):309-319. X-1, X-2, X-3, X-4, X-5, X-6 83. Lal S, Dash CH, Gribben MD. An economical method of comparing inhaled bronchodilators in reversible diffuse airways obstruction. With special reference to a beta-2 stimulant--salmefamol. Thorax 1974;29(3):317-322. X-1, X-6 84. Lim SK, Eveland WC, Porter RJ. Direct fluorescent-antibody method for the diagnosis of Pneumocystis carinii pneumonitis from sputa or tracheal aspirates from humans. Applied microbiology 1974;27(1):144- 149. X-1 85. Lopata M, Barton AD, Lourenco RV. Biochemical characteristics of bronchial secretions in chronic obstructive pulmonary disease. The American review of respiratory disease 1974;110(6):730-739. X-7 86. Lourenco RV. Conference on the scientific basis of respiratory therapy. Aerosol therapy. Introduction. The American review of respiratory disease 1974;110(6 Pt 2):85-87. X-1, X-2, X-3, X-4, X-5, X-6 87. Marriott C, Richards JH. The effects of storage and of potassium iodide, urea, N-acetyl-cysteine and triton X-100 on the viscosity of bronchial mucus. British journal of diseases of the chest 1974;68(0):171-182. X-2, X-3, X-4, X-5, X-6 88. Matthys H, Muller M, Konietzko N. Quantitative and selective bronchial clearance studies using 99 mTc- sulfate particles. Scandinavian journal of respiratory diseases Supplementum 1974;85:33-37. X-2, X-3, X- 5, X-6 89. Mitchell RG, Alder VG, Rosendal K. The classification of coagulase-negative Micrococcaceae from human and animal sources. Journal of medical microbiology 1974;7(1):131-135. X-1 90. Poppius H, Leinonen L, Muittari A. A comparative trial of salbutamol and isoprenaline in asthma. Annals of clinical research 1974;6(2):126-128. X-1, X-2, X-3, X-4, X-5, X-6 91. Shaw EL, Gasset AR. Management of an unusual case of keratitis mucosa with hydrophilic contact lenses and N-acetylcysteine. Annals of ophthalmology 1974;6(10):1054-1056. X-1, X-2, X-4 92. Skinner C, Palmer KN. Changes in specific airways conductance and forced expiratory volume in one second after a bronchodilator in normal subjects and patients with airways obstruction. Thorax 1974;29(5):574-577. X-1

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Appendix E. Quality Ratings

Table E-1. Summary of quality ratings for RCTs and crossover RCTs Author, Year Sequence Allocation Selective Other Blinding of Blinding of Incomplete Risk of Bias Generation Concealment Reporting Bias Participants/ Outcome Outcome Rating for Personnel Assessment Data Outcome Studies assessing sputum volume/weight Aliyali 201016 Low Unclear Low Low Unclear Unclear Low Poor

O’Riordan 200610 Unclear Unclear Low Low Low Low Low Fair

May 197714 Unclear Unclear Low Unclear High High Low Poor

Pulle 197011 Unclear Unclear Low Low Low Low Low Fair

Studies assessing dyspnea Black 200417 Unclear Low Low Low Low Low Low Good

Studies assessing ease of expectoration Aliyali 201016 Low Unclear Low Low Unclear Unclear Low Poor

Studies assessing pulmonary function Aliyali 201016 Low Unclear Low Low Low Low Low Fair

Jepsen 198915 Unclear Unclear Low Low Low Low High Poor

Pulle 197011 Unclear Unclear Low Low Low Low Low Fair

Black 200417 Unclear Low Low Low Low Low Low Good

Studies assessing oxygen saturation

Black 200417 Unclear Low Low Low Low Low Low Good

Studies assessing sputum viscosity

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May 197714 Unclear Unclear Low Unclear Low Low Low Poor

Pulle 197011 Unclear Unclear Low Low Low Low Low Fair

Studies assessing atelectasis Jepsen 198915 Unclear Unclear Low Low Low Low High Poor

Thomas 196612a Unclear High High High High High High Poor

Thomas 196612b Unclear High High High High High High Poor

Studies assessing length of stay Black 200417 Unclear Low Low Low Low Low Low Good

Table E-2. Quality rating for cohort studies Outcome of Represent- Adequacy Selection of Ascertain- interest not Compar- Author, ativeness Assessment Duration of of follow- Quality non-exposed ment of present at ability of Year of exposed of outcome follow-up up of Rating cohort exposure start of cohorts cohort cohorts study Desai + - + + + + + + Fair 199813

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Table E-3. Quality rating for harms reporting Author, Year Were the harms Are all pre- Did the author(s) use Are the statistical methods Quality rating predefined using specified harms STANDARD scale(s) used to assess the main harm standardized or reported? or checklist(s) for or adverse event outcomes precise definitions? harms collection? adequate?

O'Riordan No Unsure Unsure Unsure Poor 200610

Black 200417 No Unsure Yes Yes Poor

Jepsen No Unsure Unsure Unsure Poor 198915

Pulle 197011 No Unsure Unsure Unsure Poor

Thomas No Unsure Unsure Unsure Poor 196612

Quality Rating References

10. O'Riordan TG, Mao W, Palmer LB, Chen JJ. Assessing the effects of racemic and single-enantiomer albuterol on airway secretions in long-term intubated patients. Chest 2006;129(1):124-132. 11. Pulle DF, Glass P, Dulfano MJ. A controlled study of the safety and efficacy of acetylcysteine-isoproterenol combination. Current therapeutic research, clinical and experimental 1970;12(8):485-492. 12. Thomas PA, Lynch RE, Merrigan EH. Prevention of postoperative pulmonary atelectasis: review of 215 cases and evaluation of acetycysteine. The American surgeon 1966;32(5):301-307. 13. Desai MH, Mlcak R, Richardson J, Nichols R, Herndon DN. Reduction in mortality in pediatric patients with inhalation injury with aerosolized heparin/N-acetylcystine [correction of acetylcystine] therapy. The Journal of burn care & rehabilitation 1998;19(3):210-212. 14. May CS, Palmer KN. Effect of aerosol ipratropium bromide (SCH 1000) on sputum viscosity and volume in chronic bronchitis. British journal of clinical pharmacology 1977;4(4):491-492. 15. Jepsen S, Klaerke A, Nielsen PH, Nielsen ST, Simonsen O. Systemic administration of N-acetylcysteine has no effect on postoperative lung function following elective upper laparotomy in lung healthy patients. Acta anaesthesiologica Scandinavica 1989;33(3):219-222. 16. Aliyali M, Poorhasan Amiri A, Sharifpoor A, Zalli F. Effects of N-acetylcysteine on asthma exacerbation. Iranian journal of allergy, asthma, and immunology 2010;9(2):103-109. 17. Black PN, Morgan-Day A, McMillan TE, Poole PJ, Young RP. Randomised, controlled trial of N-acetylcysteine for treatment of acute exacerbations of chronic obstructive pulmonary disease [ISRCTN21676344]. BMC pulmonary medicine 2004;4:13.

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Appendix F. Harms Data Reported in Product Labeling

Harms Data for Medications Included in the Analysis

The following is an overview of the most commonly occurring and serious adverse events reported with the following medications: acetylcysteine, ipratropium, and albuterol. The information provided in this section is not an all-inclusive list of adverse events. The reader is encouraged to consult complete prescribing information. The majority of adverse events included were reported in clinical trials supporting FDA approval of specific indications; therefore, the adverse event rates may not reflect what is observed in clinical practice or when dosage, route of administration, patient population, or a combination of these factors differ. Post-marketing adverse events are reported on a voluntary basis and therefore do not represent complete patient data.

Acetylcysteine

The product labeling for acetylcysteine for inhalation or oral administration contains very limited information on adverse effects.1 Specifically, the incidence of adverse events is not provided. The adverse effects listed for inhaled acetylcysteine are as follows: stomatitis, nausea, vomiting, fever, rhinorrhea, drowsiness, clamminess, chest tightness, and bronchoconstriction. Additionally, tracheal and bronchial irritation and hemoptysis have been reported, but a causal relationship is difficult to establish in light of use in patients with bronchopulmonary disease. When administered orally, acetylcysteine is used for management of acetaminophen overdose. The primary adverse event is nausea and vomiting and is attributed to the much higher dose of acetylcysteine used in this setting and the strong, sulfuric smell of the compound. Dilution of acetylcysteine prior to oral administration is recommended to decrease the risk of vomiting.1

The most frequent adverse events associated with intravenous administration of acetylcysteine are rash, urticaria, and pruritis.2 These reactions most commonly occur during administration of the initial loading dose. Within two hours of a 15-minute or 60-minute intravenous loading dose, 17% of patients developed an anaphylactoid reaction (15 min, 18%; 60 min, 14%). Of these reactions, 1-2% were considered severe. The following adverse events were also reported: tachycardia (3-5%), nausea (2-7%), vomiting (9-12%), pharyngitis (1%), rhinorrhea (1%), rhonchi (1%), throat tightness (1%), pruritis (1-3%), rash (4-5%), and flushing (2-4%).2,3 Additional adverse event data were reported in a postmarketing safety study conducted in adults and children.2 These data are summarized in the table below.

Table 1. Intravenous Acetylcysteine: Adverse Reactions in Adults and Pediatric Patients2

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Adverse Reactions (%) Adults Children (n=4709) (n=1905) Urticaria/Facial Flushing 6.1% 7.6% Pruritis 4.3% 4.1% Respiratory Symptoms* 1.9% 2.2% Edema 1.6% 1.2% Hypotension 0.1% 0.1% Anaphylaxis 0.1% 0.2% * Respiratory symptoms include any of the following: cough, wheezing, stridor, shortness of breath, chest tightness, respiratory distress, bronchospasm.

Ipratropium

Adverse events reported by 3% or more of patients receiving ipratropium solution for nebulization are summarized in Table 2. Adverse reactions occurring in less than 3% of patients are as follows: tachycardia, palpitations, eye pain, urinary retention, urinary tract infection, urticaria. Precipitation/worsening of narrow-angle glaucoma, mydriasis, and acute eye pain have also been reported. Additionally, hypersensitivity reactions have been reported and include skin rash, angioedema, urticarial, laryngospasm, and anaphylaxis. Due to the anticholinergic effects of ipratropium, use of this agent is not recommended in patients with narrow-angle glaucoma, prostatic hypertrophy, or bladder-neck obstruction.4

Table 2. Adverse Events Occurring in >3% of Patients Treated with Ipratropium for COPD4 Adverse Reactions (%) Ipratropium* Ipratropium*/AlbuterolϮ (n=219) (n=100) Headache 6.4% 9.0% Pain 4.1% 5.0% Influenza-like Symptoms 3.7% 1.0% Back Pain 3.2% 0.0% Chest Pain 3.2% 1.0% Hypertension 0.9% 4.0% Dizziness 2.3% 4.0% Dry Mouth 3.2% 3.0% Nausea 4.1% 2.0% Arthritis 0.9% 3.0% Coughing 4.6% 6.0% Dyspnea 9.6% 9.0% Bronchitis 14.6% 20.0% Bronchospasm 2.3% 5.0% Respiratory Disorder 0.0% 4.0% Upper Respiratory Tract Infection 13.2% 16.0% Pharyngitis 3.7% 4.0% Sinusitis 2.3% 4.0% * Ipratropium 500 mcg three times per day Ϯ Albuterol 2.5 mg three times per day

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Albuterol

The reporting of adverse effects specifically associated with albuterol solution for inhalation is limited. The type and incidence of adverse events reported in FDA approved prescribing information are summarized in Table 3. In addition, the following adverse events have been reported but the incidence is not provided: urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias. Due to albuterol’s beta adrenergic activity, increases in blood pressure may occur. Although not reported in the patients represented in Table 3, repeated dosing of albuterol has been associated with decreases in serum potassium. Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis.5

Table 3. Adverse Reactions in >3% of Patients Treated with Albuterol Solution for Inhalation5 Adverse Reactions (%) Albuterol (n=135) Tremors 20% Dizziness 7% Nervousness 4% Nausea 4% Bronchospasm 8% Cough 4% Bronchitis 4%

References

1. Acetylcysteine [package insert]. Ridgefield, CA: Boehringer Ingelheim Pharmaceuticals, Inc.; 2011. 2. Acetadote [package insert]. Nashville, TN: Cumberland Pharmaceuticals Inc.; 2013. 3. Acetadote Medical Review. Silver Spring, MD: Food and Drug Administration Center for Drug Evaluation and Research; 2003. 4. Ipratropium Bromide Inhalation Solution 0.02% [package insert]. Columbia, SC: Ritedose Pharmaceuticals, LLC; 2013 5. Albuterol Sulfate Inhalation Solution 0.5% [package insert]. Tampa, FL: Bausch & Lomb Incorporated; 2013.

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Appendix G. Abbreviations and Acronyms

AARC American Association of Respiratory Care CI Confidence Interval COPD Chronic Obstructive Pulmonary Disease EPC Evidence-Based Practice Center

FEV1 Forced Expiratory Volume in 1 second FVC Forced Vital Capacity G Group ICU Intensive Care Unit KQ Key Question LOS Length of Stay n Number NAC N-acetylcysteine NR Not reported NS Not significant PEF Peak expiratory flow PICO Population, intervention, comparator(s), outcomes QOL Quality of Life RCT Randomized controlled trial

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