Reusable Face Masks to Reduce Risk of Viral Respiratory Infections and Asthma Exacerbations

NCT06885229 | Withdrawn Phase 2

• 2 other identifiers: 176722352721
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

REMASK trial is a Trial within Cohort study (TwiCs), nested within the COVIDENCE UK longitudinal study. It has been designed to determine whether the offer of a free reusable, elastomeric face mask to adults with asthma and other members of their household reduces risk of RT-PCR confirmed viral respiratory infections and asthma exacerbations.

Conditions

Acute Respiratory Infection; Asthma Exacerbations

Keywords

Upper Respiratory Infection; Acute Respiratory Infection; Asthma Exacerbation; Lower Respiratory Infection; Reusable Face Mask

Outcome Measures

Primary Outcomes (1)

• Time to first RT-PCR-proven viral respiratory infection

  12 months

Secondary Outcomes (6)

• Time to first severe acute exacerbation of asthma (i.e. exacerbation requiring treatment with systemic corticosteroids and/or hospitalisation or emergency department visit)

  12 months

• Time to first hospitalisation for treatment of acute respiratory infection or asthma exacerbation

  12 months

• Time to first antibiotic prescription for treatment of acute respiratory infection

  12 months

• Rate of RT-PCR-proven / symptom defined acute respiratory infections

  12 months

• Cost per viral respiratory infection averted

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Offer of free reusable elastometic face mask and 12-month supply of replaceable filters to index participants with asthma and their adult household members

Device: FloMask - reuseable face mask

Control

NO INTERVENTION

Usual asthma care without offer of intervention above

Interventions

FloMask - reuseable face mask DEVICE

Reuseable, elastomeric face mask with replaceable filters

Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 16 or more years
• Doctor diagnosis of asthma
• Current prescription for treatment of asthma
• Participant in COVIDENCE UK nasal swab study

You may not qualify if:

• Regularly using any FFP-rated face mask when in an indoor public place
• Currently sharing household with one or more children
• Currently sharing household with one or more other COVIDENCE UK participants who have asthma
• Unable to tolerate wearing face mask
• Eligibility criteria, household members of index participants:
• Age 16 or more
• Living in same household as index participant who has consented to take part in trial
• \- Unable to tolerate wearing face mask

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University of London

London, Greater London, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 20, 2025
• Study Start: March 27, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)