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Efficacy of a Steroid Nasal Spray Compared with an Antihistamine

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Efficacy of a Steroid Nasal Spray Compared with an Antihistamine congestion, effect on sleep, and daytime Efficacy of a steroid nasal spray fatigue.5,6 Our study was conducted to compare the efficacy of the topical nasal compared with an antihistamine steroid (flunizolide) with the antihis- nasal spray in the treatment of tamine (azelastine) nasal spray in the treatment of symptoms associated with perennial allergic rhinitis perennial allergic rhinitis. JOSHUA M. BERLIN, MD; STANLEY J. GOLDEN, MS; Materials and methods STEPHANIE TEETS, MD; ERIK B. LEHMAN, MA; The investigation was designed to com- TIMOTHY LUCAS, MD; TIMOTHY J. CRAIG, DO pare two double-blind, placebo-con- trolled, crossover studies performed at Allergic rhinitis is a common disease with a lifetime prevalence of 20% among the our institution which analyzed the effect United States population. The cost of medication alone to manage allergic rhini- of a topical nasal corticosteroid (Nasarel, tis in the United States was estimated to be $3.1 billion. The two most com- Dura, San Diego, Calif) versus placebo monly prescribed classes of medications are antihistamines and topical nasal and an antihistamine nasal spray (Astelin, steroids. The data on comparing the efficacy of a commonly used antihistamine Wallace Laboratories, Cranbury, NJ) (azelastine hydrochloride) with that of topical steroids, however, are conflicting. versus placebo. Both studies were ran- Therefore, the reported study was undertaken to determine the efficacy of azelastine domized using Balaam’s design with four with that of a topical nasal steroid (flunisolide) in treating patients for the symp- groups: AA (active-active), PA (placebo- toms of perennial allergic rhinitis. Forty-four subjects were enrolled in a double- active), AP (active-placebo), and PP blind, placebo-controlled study using Balaam’s design. In one group, patients (placebo-placebo). were treated with topical nasal corticosteroids or placebo. In the other group, Twenty patients with perennial aller- patients were treated with the antihistamine nasal spray or placebo. Subjective data gic rhinitis were selected for the topical were collected by the use of questionnaires and a daily diary, which focused on nasal nasal corticosteroid study whereas 24 symptoms, sleep, and daytime sleepiness. patients with perennial allergic rhinitis The results demonstrated that the topical nasal corticosteroid performed supe- were selected for the antihistamine nasal riorly to the antihistamine nasal spray in improving sleep, daytime sleepiness, spray study. These patients were selected sneezing, ocular and nasal pruritus, and nasal congestion. Thus, the topical nasal through a screening process on the basis corticosteroid was found to be more effective than antihistamine nasal spray in reduc- of certain inclusion and exclusion criteria. ing symptoms of allergic rhinitis. This study provides further support for the use of The sample size was appropriate to topical nasal corticosteroids as first-line treatment for perennial allergic rhinitis. demonstrate a 20% reduction in con- (Key words: azelastine hydrochloride, antihistamines, allergic rhinitis, flu- gestion at a power of 80% and a level of nisolide, corticosteroids, nasal congestion, sleep, fatigue, sleep disorders, sleep significance of .05.7 Advertisement, with disturbances, allergic disease) institutional review board approval, was used to recruit subjects. llergic rhinitis is a common disease for allergic rhinitis. Topical intranasal Inclusion criteria included: Awith a lifetime prevalence of 20% corticosteroids inhibit the influx of Ⅺ age 18 to 55 years, among the population of the United inflammatory cells and result in a Ⅺ daytime fatigue, States.1 The use of antihistamines and decrease in the number of mast cells, Ⅺ daytime somnolence, topical nasal steroids represents the cor- Th2 lymphocytes, and eosinophils.2,3 Ⅺ nasal congestion, nerstones of pharmacologic treatment The mechanism of action of antihis- Ⅺ perennial allergic rhinitis with a pos- tamines involves preventing the H1-recep- itive skin test response for perennial From the Allergy Service, Section of Pulmonary, у Allergy, and Critical Care, Division of Medicine tor–histamine interaction. Azelastine allergen (wheal diameter 3 mm), (Drs Lucas and Craig); the College of Medicine hydrochloride represents a novel anti- and (Dr Berlin, Mr Golden, and Dr Teets); and the histamine in this class as a result of its Ⅺ a negative skin test response for sea- Department of Health Evaluation Sciences (Mr Lehman), Penn State University, Hershey, Pa. probable anti-inflammatory effects and sonal allergens. Funded by the General Clinical Research topical application.4 Exclusion criteria included: Center (GCRC), Penn State University, Her- Previous studies have demonstrated Ⅺ seasonal allergies, shey Medical Center. The GCRC is supported Ⅺ by National Institutes of Health (NIH). the effects of the topical nasal steroid known sleep apnea, Correspondence to Timothy J. Craig, DO, flunisolide and the antihistamine nasal Ⅺ nasal polyps, Department of Medicine, Section of Pulmonary, spray azelastine hydrochloride compared Ⅺ obesity, Allergy, and Critical Care, 500 University Drive, Ⅺ Hershey, PA 17033. with those of placebo in treating peren- recent upper respiratory tract infec- E-mail: [email protected] nial allergic rhinitis and its associated tion, S8 • JAOA • Vol 100 • No 7 • Supplement to July 2000 Berlin et al • A steroid nasal spray compared with an antihistamine nasal spray Table 1 Demographics Reflecting Population Characteristics for Study Comparing a Steroid Nasal Spray (Flunisolide) With an Antihistamine Nasal Spray (Azelastine Hydrochloride) Drug and Balaam’s Mean Study design sequence age, y Male, No. Female, No. dropouts, No. Ⅵ Flunisolide Ⅺ Active-active 37.5 0 5 0 Ⅺ Active-placebo 42.0 2 3 1* Ⅺ Placebo-active 33.6 3 2 0 Ⅺ Placebo-placebo 42.0 2 3 0 Ⅵ Azelastine hydrochloride Ⅺ Active-active 44.67 1 2 2† Ⅺ Active-placebo 34.2 4 1 2† Ⅺ Placebo-active 33.2 3 2 0 Ⅺ Placebo-placebo 31.5 3 3 1‡ * Patient withdrew because of inability to continue receiving the placebo owing to the severity of the symptoms. † Patients withdrew becaue of sedation. ‡ Patient withdrew because of relocating out of town. Ⅺ deviated septum, and symptoms, sleep, daytime somnolence, able over the 7 days in each week sepa- Ⅺ asthma or other respiratory diseases. and response to the medication. The rately so that each patient would have a Only the research treatment was patients were seen every 2 weeks to summary score for each variable of inter- allowed during the study. ensure compliance with the medications est for the 4th and 8th weeks. Once the Patients were screened by history, and daily diary. The diary contained 9 summary scores were calculated, we used physical examination, symptom assess- questions about the severity of the symp- the procedure PROC MIXED in SAS to ment, and skin testing. Skin testing was toms (congestion, sneezing, rhinorrhea, analyze the data with the summary score done by the prick method (Hollister Steir, itchy nose, irritated eyes, daytime sleepi- being the response variable.11,12 The dif- Spokane, Wash) with mixed mite, dog, ness, daytime fatigue, quality of sleep, ferences between the topical nasal and cat, roach, Alternaria, Aspergillus, Peni- and number of awakenings); 4 questions the antihistamine nasal spray in treat- cillium, and 10 seasonal allergens (Hol- about the patient’s opinion of the ing patients for allergic rhinitis were lister Steir, Spokane, Wash). Only improvement of the symptoms caused determined by comparing the difference patients who met all criteria were by the medication (sleep, daytime sleepi- between each treatment mean and its enrolled. Each subject was seen every 2 ness, daytime fatigue, and congestion), corresponding placebo mean (treatment weeks after the initial screening visit for and 1 question about the degree of the mean-placebo mean) for each measure. a total of five visits. patient’s sleepiness. The questions used In order to account for variation between During the initial visit, patients were were based on previously published the two studies, the data were adjusted randomly assigned to the treatment reg- diaries to determine the severity of the for age and gender. imen that was dictated by the first peri- rhinitis.7-10 od of the sequence to which they were Questions on congestion, sleep, day- Results designated. Reevaluation was done at time sleepiness, and fatigue were asked in Nineteen of the 20 patients who entered weeks 2, 4, 6, and 8. At the third visit, two different fashions. The first con- the topical steroid study completed the which was during the middle of the 8 cerned the severity of symptoms, and protocol while 19 of the 24 patients who weeks, the patients were crossed over to the second concerned the improvement entered the antihistamine nasal spray the treatment that was required for the of symptoms with therapy. Severity of study completed the protocol. The data second period of the sequence to which symptoms was rated on a scale that from the patients who did not complete they were assigned. Treatment consisted ranged from 0 (none) to 4 (severe). the study were excluded from the final of two sprays twice daily of placebo Improvement was rated on a scale that analysis. The demographics of the patient (saline solution) or the topical nasal ranged from 0 (none) to 4 (greatly population are reflected in Table 1. The steroid or the antihistamine nasal spray improved). Data were summarized from results, including means, standard errors, in each
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