The Effect of Dyson Air Purifier in Improving Asthma Control

August 4, 2022 updated by: The David Hide Asthma & Allergy Research Centre

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in asthma quality of life score
Time Frame: 18 months
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
Time Frame: 18 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in airway responsiveness
Time Frame: 18 months
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
Time Frame: 18 months
Changes in indoor levels of pollutants that are recorded by Dyson purifier.
18 months
Pulmonary function: forced expiratory volume in one second (FEV1)
Time Frame: 18 months
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
Time Frame: 18 months
Pulmonary function as assessed by changes FEV1/FVC (Forced Vital Capacity) ratio
18 months
Pulmonary function: mid-expiratory flows.
Time Frame: 18 months
Pulmonary function as assessed by changes in mid expiratory flows.
18 months
Exhaled Nitric Oxide
Time Frame: 18 months
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
Time Frame: 18 months
Change in peak expiratory flow from baseline will be compared in the two groups.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The David Hide Asthma & Allergy Research Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Isle of Wight NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: S. Hasan Arshad, University of Southampton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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