NCT04729530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

November 6, 2019

Last Update Submit

August 4, 2022

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Change in airway responsiveness

    18 months

  • Change in indoor pollutant level

    18 months

  • Pulmonary function: forced expiratory volume in one second (FEV1)

    18 months

  • Pulmonary function: FEV1 (forced expiratory volume in one second) /FVC (Forced Vital Capacity) ratio

    18 months

  • Pulmonary function: mid-expiratory flows.

    18 months

  • +2 more secondary outcomes

Study Arms (2)

Active

ACTIVE COMPARATOR

Air purifier device with standard filter cartridges installed.

Device: Dyson Pure Cool - Active Purifier

Placebo

PLACEBO COMPARATOR

Air purifier device with placebo (non working) filter cartridges installed.

Device: Dyson Pure Cool - Placebo purifier

Interventions

Dyson Pure Cool - Active PurifierDEVICE

Free standing air purifier

Active
Dyson Pure Cool - Placebo purifierDEVICE

Placebo air purifier

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The David Hide Asthma and Allergy Research Centre

Newport, Isle Of Wight, PO30 5TG, United Kingdom

Location

Related Publications (2)

  • Fong WCG, Kadalayil L, Lowther S, Grevatt S, Potter S, Tidbury T, Bennett K, Larsson M, Nicolas F, Kurukulaaratchy R, Arshad SH. The efficacy of the Dyson air purifier on asthma control: A single-center, investigator-led, randomized, double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2023 Feb;130(2):199-205.e2. doi: 10.1016/j.anai.2022.10.010. Epub 2022 Oct 23.

    PMID: 36288782DERIVED

  • 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.

    PMID: 34313599DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • S. Hasan Arshad

    University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2019

First Posted

January 28, 2021

Study Start

September 3, 2019

Primary Completion

July 21, 2021

Study Completion

July 21, 2021

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)