The Effect of Dyson Air Purifier in Improving Asthma Control

The Effect of Dyson Air Purifier in Improving Asthma Control - A Randomised, Controlled Trial

To investigate the effect of reducing the level of allergens and pollutants in the bedroom and living room by placing a "Dyson air purifier", on poorly controlled asthmatic subjects.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Dyson Pure Cool - Active Purifier; Device: Dyson Pure Cool - Placebo purifier

Detailed Description

Asthma is one of the most common chronic diseases. Little change in morbidity and mortality has occurred despite improvements in pharmacotherapy. In the last few decades, there has been an increase in the prevalence of asthma and other allergic diseases. The precise cause for this increase in disease prevalence is not known but it has coincided with changes to the quality of indoor air with increases in the levels of allergens and pollutants. Bedroom exposure to dust-mite allergens has been linked to worsening asthma symptoms and increase in bronchial responsiveness. In places where dust mites cannot thrive, allergens from cat, cockroach and Alternaria assume importance. High indoor temperatures and humidity may, by a number of mechanisms, increase the allergenic burden, particularly the proliferation of house-dust mites and moulds. Therefore, modern living conditions are associated with a higher risk of allergen exposure causing increase in sensitisation and symptoms of asthma. In addition to allergens, the indoor environment contains other biological materials (such as microbiome and endotoxin), and pollutants (gases and particulate matter) which can adversely affect asthma development and morbidity. Indoor pollutants include smoke from cigarettes and wood, coal or gas fires, particulate materials associated with bio-fuel combustion, chemical vapours and gases including nitrogen dioxide (NO2), formaldehyde and volatile organic compounds (VOCs). The latter may come from sources including building products, cleaning agents, and paints. One such VOC is formaldehyde, which can be irritant to both upper and lower respiratory tract. Small particulate matter (PM2.5) is particularly damaging as it gets to the small airways of the lung. Major indoor sources of NO2 and particulate matter include gas stoves and cigarette smoke but outdoor sources such as traffic and industrial pollution can also contaminate indoor environment.

It has also been suggested that exposure to pollutants can potentiate the effects of allergen. Indeed, a combination of high levels of indoor pollution and allergens is causally related to the development and severity of asthma. Allergens, microbiome and pollutants can interact with each other to augment the immune response leading to harmful effects on the airways.

Thus, indoor air pollution is a significant environmental trigger for acute exacerbation of asthma (and other respiratory conditions such as COPD), leading to increasing symptoms, emergency department visits, hospital admissions and even mortality. An estimated 75% of hospital admissions for asthma are avoidable. Maintaining high air quality with lower levels of allergens and pollutants is therefore important in improving the health of individuals with asthma and other respiratory diseases. Therefore, a feasible and practical intervention that can reduce allergen and pollutant levels in the indoor air should reduce morbidity and improve asthma control.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Isle Of Wight
    • Newport, Isle Of Wight, United Kingdom, PO30 5TG
      • The David Hide Asthma and Allergy Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between 18 to 75 years of age with a confirmed diagnosis of mild persistent to moderate persistent asthma (BTS steps "regular preventer therapy" to "additional add-on therapies")
• ACQ6 score >1.5.

Exclusion Criteria:

• Patients with significant chronic respiratory disease such as COPD or bronchiectasis.
• Patients with any severe disease (such as cardiovascular disease, dementia etc.), where adherence to the study protocol may cause an unjustified stress.
• Those who are being treated with allergen specific immunotherapy.
• Patients with a history of significant alcohol or drug abuse.
• Patients who are taking an investigational drug for asthma.
• Patients who are unwilling, unlikely or unable to comply with the study protocol, as assessed by the study team members.
• Patients who are likely to be started on biological therapies for asthma (omalizumab, mepolizumab, reslizumab, dupilumab) during the study period.
• Pregnancy.
• Patients already using air purifiers in their dwellings.
• Patients planning to move house during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Air purifier device with standard filter cartridges installed.	Device: Dyson Pure Cool - Active Purifier; Free standing air purifier
Placebo Comparator: Placebo; Air purifier device with placebo (non working) filter cartridges installed.	Device: Dyson Pure Cool - Placebo purifier; Placebo air purifier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in asthma quality of life score	Change in Juniper asthma specific quality of life (AQLQ) scores: A change in score of 0.5 on the 7-point scale is considered clinically important (Minimal Important Difference).	18 months
Change in asthma control score	Change in asthma control composite scores using Juniper asthma control questionnaire (ACQ6). A change in score of 0.5 on the 6-point scale is considered clinically important.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in airway responsiveness	Change in airway responsiveness from baseline will be compared in the two groups (as assessed by methacholine bronchial challenge).	18 months
Change in indoor pollutant level	Changes in indoor levels of pollutants that are recorded by Dyson purifier.	18 months
Pulmonary function: forced expiratory volume in one second (FEV1)	Pulmonary function as assessed by changes in forced expiratory volume in one second (FEV1),	18 months
Pulmonary function: FEV1 (forced expiratory volume in one second) /FVC (Forced Vital Capacity) ratio	Pulmonary function as assessed by changes FEV1/FVC (Forced Vital Capacity) ratio	18 months
Pulmonary function: mid-expiratory flows.	Pulmonary function as assessed by changes in mid expiratory flows.	18 months
Exhaled Nitric Oxide	Change in exhaled nitric oxide levels (as an indicator of airway inflammation) from baseline will be compared in the two groups.	18 months
Peak expiratory flow	Change in peak expiratory flow from baseline will be compared in the two groups.	18 months

Collaborators and Investigators

• Sponsor: The David Hide Asthma & Allergy Research Centre
• Collaborators: Isle of Wight NHS Trust
• Investigators: Principal Investigator: S. Hasan Arshad, University of Southampton

Publications and helpful links

General Publications

• Fong WCG, Grevatt S, Potter S, Tidbury T, Kadalayil L, Bennett K, Larsson M, Nicolas F, Kurukulaaratchy R, Arshad SH. 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 Res Protoc. 2021 Jul 27;10(7):e28624. doi: 10.2196/28624.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): July 21, 2021

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: DYSON-ASTHMA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No