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The Efficacy of the Dyson Air Purifier in Improving Asthma Control: Protocol for a Single-Center, Investigator-Led, Randomized, Double-Blind, Placebo-Controlled Trial

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The Efficacy of the Dyson Air Purifier in Improving Asthma Control: Protocol for a Single-Center, Investigator-Led, Randomized, Double-Blind, Placebo-Controlled Trial JMIR RESEARCH PROTOCOLS Fong et al Protocol The Efficacy of the Dyson Air Purifier in Improving Asthma Control: Protocol for a Single-Center, Investigator-Led, Randomized, Double-Blind, Placebo-Controlled Trial Wei Chern Gavin Fong1,2; Susan Grevatt1; Stephen Potter1; Tracey Tidbury1; Latha Kadalayil1,2; Kaisha Bennett1; Maria Larsson1; Frédéric Nicolas3; Ramesh Kurukulaaratchy1,2; Syed Hasan Arshad1,2 1David Hide Asthma and Allergy Research Centre, Newport, United Kingdom 2School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom 3Dyson Technology Limited, Tetbury Hill, Malmesbury, Wiltshire, United Kingdom Corresponding Author: Syed Hasan Arshad David Hide Asthma and Allergy Research Centre Isle Of Wight NHS Trust Newport, United Kingdom Phone: 44 (0) 1983 534373 Email: [email protected] Abstract Background: Indoor air quality has been shown to influence asthma control and outcomes. Air purifiers and high-efficiency particulate air filtration devices can improve indoor air quality by reducing the indoor levels of air pollution and allergens. However, the influence of this improved indoor air quality on asthma control remains unclear; hence, randomized controlled trials are needed to further elucidate this phenomenon. Objective: This study aims to investigate the effect of reducing the levels of allergens and pollutants in the bedroom and living room through the use of Dyson air purifiers (Dyson Pure Cool) on asthma control. Methods: This is an 18-month long, investigator-led, randomized, double-blinded, placebo-controlled, single-center trial. Subjects will be randomized in a 1:1 ratio to active or placebo Dyson filters. The primary outcome is the change in the scores of Asthma Control Questionnaire 6 and Asthma-specific Quality of Life Questionnaire from baseline. Secondary outcomes include changes in lung function (forced expiratory volume in one second, forced expiratory volume in one second/forced vital capacity ratio, and midexpiratory flows), peak expiratory flow measurements, airway hyperresponsiveness (assessed by methacholine bronchial challenge), fractional exhaled nitric oxide, and indoor air pollutant levels. The sample size will be 50 subjects, and all subjects will have a confirmed diagnosis of mild persistent to moderate persistent asthma along with an Asthma Control Questionnaire 6 score of >1.5. Results: This study was approved by the West Midlands Research Ethics Committee (18/WM/0277). The study results will be published in peer-reviewed scientific journals; presented at relevant scientific conferences; and shared in plain English with participants in our newsletters, in our clinics, and via the David Hide Asthma and Allergy Research Centre website. Our trial began in September 2019 and is expected to end in August 2021. Conclusions: This is a double-blinded, placebo-controlled, randomized, investigator-led study to investigate the efficacy of a novel air purifier in improving asthma control in adults. The trial period of 18 months will facilitate the collection of robust data and will therefore generate clear signals. However, this extended trial duration may lead to patient withdrawal. Furthermore, this trial is conducted at a single center and in a location with a homogenous cohort of people, which may affect translatability. Nonetheless, it is hoped that the findings of this trial may help further inform clinicians regarding the utility of this novel device as an adjunct in asthma care. Trial Registration: ClinicalTrials.gov NCT04729530; https://clinicaltrials.gov/ct2/show/NCT04729530 International Registered Report Identifier (IRRID): DERR1-10.2196/28624 (JMIR Res Protoc 2021;10(7):e28624) doi: 10.2196/28624 https://www.researchprotocols.org/2021/7/e28624 JMIR Res Protoc 2021 | vol. 10 | iss. 7 | e28624 | p. 1 (page number not for citation purposes) XSL·FO RenderX JMIR RESEARCH PROTOCOLS Fong et al KEYWORDS air purifier; asthma; clinical trial; air pollution; allergens; respiratory function tests; bronchial provocation tests environment in improving asthma control [9]. The workshop Introduction concluded that apart from the replacement of gas stoves with Background electric stoves and avoidance of indoor smoking, few methods are currently available for reducing indoor NO and possibly The last few decades have been witnessing an ongoing asthma 2 other pollutants. Technological improvements have been made epidemic, whereby there is an increasing prevalence of asthma in improving the efficacy of high-efficiency particulate air in the Western world and beyond [1]. The precise cause of this (HEPA) particle filtration devices that are designed to remove phenomenon is not fully understood, but it has coincided with the targeted indoor air pollutants, such as fine PM (PM2.5) [13]. changes in the quality of indoor air, which contains increased Some studies have demonstrated a positive effect of using an levels of allergens and pollutants [2]. The indoor environment air cleaner with HEPA and carbon filters on asthma symptoms contains other biological materials (such as microbiome and [14-16]. Although most studies using air purifiers have shown endotoxin) and pollutants (gases and particulate matter [PM]), a reduction in gases and PM, the overall effect on asthma control which can adversely affect the development and morbidity of remains uncertain. Allergen reduction intervention studies have asthma [3]. Indoor pollutants also include smoke from cigarettes reported inconsistent results [10]. Therefore, novel intervention and wood, coal or gas fires, particulate materials associated with strategies are needed to reduce both allergens and pollutants in biofuel combustion, chemical vapors, gases including nitrogen the indoor environment to the extent that can improve asthma dioxide (NO ), formaldehyde, and volatile organic compounds 2 control and reduce airway inflammation and (VOCs). The latter may come from sources such as building hyperresponsiveness. Recently, nocturnal products, cleaning agents, and paints. One such VOC is temperature±controlled laminar airflow technology has been formaldehyde, which can irritate both the upper and lower investigated for treating atopic asthma with some benefits [17]. respiratory tracts [4]. Small PM (PM2.5) is particularly It has been suggested that this strategy of reducing indoor damaging as it penetrates the small airways of the lungs and exposure to allergens and pollutants might be cost-effective may even enter the bloodstream. Major indoor sources of NO2 [18]. However, this result was not observed in a recent large and PM include gas stoves and cigarette smoke, but outdoor randomized controlled trial investigating this technology [19]. sources such as traffic and industrial pollution can also contaminate the indoor environment [5]. Among the indoor Objectives allergens, bedroom exposure to dust mite has been linked to The purpose of this study is to investigate the effects of reducing worsening asthma symptoms and increased bronchial the levels of allergens and pollutants in the bedroom and living responsiveness [6]. In places where dust mites cannot thrive, room, via a novel HEPA air purifier, on asthma control. allergens from cats, cockroaches, and Alternaria assume Specifically, this study aims to investigate whether placing importance [7]. High indoor temperatures and humidity may novel Dyson Pure Cool Towers [20], which have additional increase the allergenic burden, particularly the proliferation of purification functions, in the bedroom and living room of house dust mites and molds [7]. Therefore, modern living subjects with asthma will improve their asthma control. The conditions are associated with a higher risk of allergen exposure, study hypothesizes that the addition of the Dyson air purifier which causes an increase in the sensitization and symptoms of to the standard treatment will improve asthma control, as asthma. assessed by the Juniper Asthma Control Questionnaire 6 (ACQ6) score [21], and improve the quality of life, as assessed by the It has also been suggested that exposure to pollutants can Juniper Asthma-Specific Quality of Life Questionnaire (AQLQ) potentiate the effects of allergens [8]. Indeed, a combination of score [22], as a result of reducing indoor allergen and pollutant high levels of indoor pollution and allergens is related to the levels. development and severity of asthma [9]. Allergens, microbiome, and pollutants can interact with each other to augment the immune response, further leading to harmful effects on the Methods airways [10,11]. Study Design Thus, indoor air pollution (both chemical and biological) is a This is an investigator-led, single-center, double-blinded, considerable environmental trigger for the acute exacerbation placebo-controlled, randomized controlled trial, with a 1:1 of asthma, which leads to increasing symptoms, emergency randomization ratio to an active or placebo filter. The David department visits, hospital admissions, and even mortality Hide Asthma and Allergy Research Centre (DHAARC), Isle of [3,9,12]. Therefore, maintaining a high air quality with lower Wight National Health Service Trust, Isle of Wight, United levels of allergens and pollutants is important for improving Kingdom, will serve as the study site. the health of individuals with asthma and other respiratory diseases. A feasible and practical intervention that can reduce Sample Size allergen and pollutant levels in indoor air should reduce As the trial will be using
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