The Effect of Dyson Air Purifier in Improving Asthma Control
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dyson Pure Cool - Active Purifier
Dyson Pure Cool - Placebo purifier
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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.
Sites / Locations
- The David Hide Asthma and Allergy Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Air purifier device with standard filter cartridges installed.
Air purifier device with placebo (non working) filter cartridges installed.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Change in airway responsiveness
Change in airway responsiveness from baseline will be compared in the two groups (as assessed by methacholine bronchial challenge).
Change in indoor pollutant level
Changes in indoor levels of pollutants that are recorded by Dyson purifier.
Pulmonary function: forced expiratory volume in one second (FEV1)
Pulmonary function as assessed by changes in forced expiratory volume in one second (FEV1),
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
Pulmonary function: mid-expiratory flows.
Pulmonary function as assessed by changes in mid expiratory flows.
Exhaled Nitric Oxide
Change in exhaled nitric oxide levels (as an indicator of airway inflammation) from baseline will be compared in the two groups.
Peak expiratory flow
Change in peak expiratory flow from baseline will be compared in the two groups.
Full Information
NCT ID
NCT04729530
First Posted
November 6, 2019
Last Updated
August 4, 2022
Sponsor
The David Hide Asthma & Allergy Research Centre
Collaborators
Isle of Wight NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04729530
Brief Title
The Effect of Dyson Air Purifier in Improving Asthma Control
Official Title
The Effect of Dyson Air Purifier in Improving Asthma Control - A Randomised, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The David Hide Asthma & Allergy Research Centre
Collaborators
Isle of Wight NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Air purifier device with standard filter cartridges installed.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Air purifier device with placebo (non working) filter cartridges installed.
Intervention Type
Device
Intervention Name(s)
Dyson Pure Cool - Active Purifier
Intervention Description
Free standing air purifier
Intervention Type
Device
Intervention Name(s)
Dyson Pure Cool - Placebo purifier
Intervention Description
Placebo air purifier
Primary Outcome Measure Information:
Title
Change in asthma quality of life score
Description
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).
Time Frame
18 months
Title
Change in asthma control score
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in airway responsiveness
Description
Change in airway responsiveness from baseline will be compared in the two groups (as assessed by methacholine bronchial challenge).
Time Frame
18 months
Title
Change in indoor pollutant level
Description
Changes in indoor levels of pollutants that are recorded by Dyson purifier.
Time Frame
18 months
Title
Pulmonary function: forced expiratory volume in one second (FEV1)
Description
Pulmonary function as assessed by changes in forced expiratory volume in one second (FEV1),
Time Frame
18 months
Title
Pulmonary function: FEV1 (forced expiratory volume in one second) /FVC (Forced Vital Capacity) ratio
Description
Pulmonary function as assessed by changes FEV1/FVC (Forced Vital Capacity) ratio
Time Frame
18 months
Title
Pulmonary function: mid-expiratory flows.
Description
Pulmonary function as assessed by changes in mid expiratory flows.
Time Frame
18 months
Title
Exhaled Nitric Oxide
Description
Change in exhaled nitric oxide levels (as an indicator of airway inflammation) from baseline will be compared in the two groups.
Time Frame
18 months
Title
Peak expiratory flow
Description
Change in peak expiratory flow from baseline will be compared in the two groups.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Hasan Arshad
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
The David Hide Asthma and Allergy Research Centre
City
Newport
State/Province
Isle Of Wight
ZIP/Postal Code
PO30 5TG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34313599
Citation
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.
Results Reference
derived
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The Effect of Dyson Air Purifier in Improving Asthma Control
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