NCT04302610

Brief Summary

The overall aim of this study is to determine if face masks that can warm and humidify air can improve overall asthma control and markers of airway health during exercise in cold dry environments. We will investigate the potential protective benefits of the face masks against exercise induced asthma during 1) a "one-off" bout of exercise in a cold dry environment and 2) over the course of a four week period, exercising three times per week in a cold dry environment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

May 1, 2016

Enrollment Period

1.6 years

First QC Date

March 6, 2020

Last Update Submit

March 6, 2020

Conditions

Asthma, Exercise-InducedAsthma

Outcome Measures

Primary Outcomes (1)

  • % fall in FEV1

    Change in Forced Expiratory Volume in One Second from baseline to post exercise

    30 minutes

Secondary Outcomes (1)

  • coughs per hour after EX

    24 hours

Study Arms (3)

HME MASK

EXPERIMENTAL

During the Exercise, participants wore either an HME mask (MASK) (ColdAvenger® expedition balaclava, USA, www.coldavenger.com)

Device: Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA,

SHAM mask

SHAM COMPARATOR

a sham mask (SHAM) which was the same HME mask with holes cut across the entire ventilator cup and the ventilator removed

Device: Sham treatment

Control

NO INTERVENTION

No mask (CONT) wearing only the balaclava to which the HME and SHAM mask were attached. Mouth and face not covered.

Interventions

Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA,DEVICE

A heat and moisture exchange mask will warm and humidify inspired air and therefore reduce airway heat and water loss during exercise. This will potentially reduce the incidence of and severity of EIB and may also have the potential to decrease the incidence of cough amongst athletes engaging in sports in cold dry environments

HME MASK
Sham treatmentDEVICE

Same as the HME mask but active HME parts withdrawn from devices and multiple holes made in mouth piece to improve ventilation of mask and reduce HME ability of mask

SHAM mask

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to consent to the research
  • Prior clinician based diagnosis of asthma
  • Males and females
  • years
  • Engage in regular exercise (at least twice weekly)
  • Normal resting Forced Expiratory Volume in One Second (FEV1); defined as greater than 80% of predicted value.

You may not qualify if:

  • Chest infection within the past 4 weeks, or any other illness within the past 2 weeks
  • Fall in FEV1 \>50% from baseline following exercise challenge (see protocol)
  • Baseline FEV1 of \< 80% of predicted
  • Cardiovascular conditions:
  • Coronary Artery Disease
  • High Blood Pressure
  • Heart Failure
  • Diagnosed Abnormality of Heart Rhythm
  • Metabolic diseases:
  • Type 1 diabetes
  • Type 2 diabetes
  • Pre-diabetes
  • Daily use of oral corticosteroids
  • Hospitalisation due to asthma in the six months prior to study commencement
  • Injury or conditions that limit mobility
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma, Exercise-InducedAsthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • John W Dickinson, PhD

    University of Kent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Heat Exchange Mask SHAM Mask
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: randomised cross-over design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

September 1, 2016

Primary Completion

April 1, 2018

Study Completion

May 15, 2018

Last Updated

March 10, 2020

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share