Do Heat and Moisture Exchange Mask Reduce EIB and Cough Severity in Asthma
Primary Purpose
Asthma, Exercise-Induced, Asthma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA,
Sham treatment
Sponsored by
About this trial
This is an interventional prevention trial for Asthma, Exercise-Induced
Eligibility Criteria
Inclusion Criteria:
- Ability to consent to the research
- Prior clinician based diagnosis of asthma
- Males and females
- 18 - 45 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.
Exclusion Criteria:
- 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
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
HME MASK
SHAM mask
Control
Arm Description
During the Exercise, participants wore either an HME mask (MASK) (ColdAvenger® expedition balaclava, USA, www.coldavenger.com)
a sham mask (SHAM) which was the same HME mask with holes cut across the entire ventilator cup and the ventilator removed
No mask (CONT) wearing only the balaclava to which the HME and SHAM mask were attached. Mouth and face not covered.
Outcomes
Primary Outcome Measures
% fall in FEV1
Change in Forced Expiratory Volume in One Second from baseline to post exercise
Secondary Outcome Measures
coughs per hour after EX
Number of coughs per hour in a 24 hour period after exercise
Full Information
NCT ID
NCT04302610
First Posted
March 6, 2020
Last Updated
March 6, 2020
Sponsor
University of Kent
Collaborators
Asthma UK, Royal Brompton & Harefield NHS Foundation Trust, King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04302610
Brief Title
Do Heat and Moisture Exchange Mask Reduce EIB and Cough Severity in Asthma
Official Title
The Use of a Heat and Moisture Exchange Mask to Reduce Exercise Induced Bronchoconstriction Severity and Improve the Airway Health of Individuals With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kent
Collaborators
Asthma UK, Royal Brompton & Harefield NHS Foundation Trust, King's College Hospital 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
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.
Detailed Description
Physical activity is recognised as a trigger for individuals with asthma, however regular physical activity is considered to be important in the overall management of the condition. There is clear evidence that demonstrates if individuals with asthma engage with regular physical activity they will improve their physical fitness and breathing control, whilst at the same time experiencing reductions in asthma severity, symptoms, and medication use. In addition undertaking regular exercise reduces the risk of developing other diseases such as heart disease or type 2 diabetes. Despite the clear health benefits of engaging in regular physical activity there is evidence that some people with asthma avoid physical activity due to shortness of breath, worsening asthma symptoms during physical activity or fear of experiencing such symptoms.
Physical activity in cold dry environments exacerbates symptoms for many individuals with asthma resulting in greater avoidance of physical activity during the winter months. The increased risk of asthma from exercising in cold environments has led to Asthma UK advising susceptible individuals to avoid exercise outside in cold environments (http://www.asthma.org.uk/advice-exercise). This places obvious constraints and limitations on individuals with asthma for whom the aim of optimum treatment is to allow them to follow a "normal" lifestyle. Indeed, exposure to cold air on exertion is relevant to a significant proportion of individuals with asthma who engage with outdoor physical activity as part of their daily routine; e.g. cycle-commuting to work, outdoor construction workers.
A mask that is able to warm and humidify the air during exercise may provide a solution for asthmatic individuals susceptible to cold dry environments. There are a limited number of small studies that provide tentative evidence suggesting masks which warm and humidify air can protect against reductions in lung function during and following physical activity. However, it is unknown whether the use of these masks provides protection against the mechanisms that drive asthmatic symptoms. It is also unclear whether using the masks over a prolonged period of time significantly reduces asthma severity, inhaler use, or presence of symptoms.
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 environme
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Exercise-Induced, Asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomised cross-over design
Masking
Participant
Masking Description
Heat Exchange Mask SHAM Mask
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HME MASK
Arm Type
Experimental
Arm Description
During the Exercise, participants wore either an HME mask (MASK) (ColdAvenger® expedition balaclava, USA, www.coldavenger.com)
Arm Title
SHAM mask
Arm Type
Sham Comparator
Arm Description
a sham mask (SHAM) which was the same HME mask with holes cut across the entire ventilator cup and the ventilator removed
Arm Title
Control
Arm Type
No Intervention
Arm Description
No mask (CONT) wearing only the balaclava to which the HME and SHAM mask were attached. Mouth and face not covered.
Intervention Type
Device
Intervention Name(s)
Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA,
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
% fall in FEV1
Description
Change in Forced Expiratory Volume in One Second from baseline to post exercise
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
coughs per hour after EX
Description
Number of coughs per hour in a 24 hour period after exercise
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to consent to the research
Prior clinician based diagnosis of asthma
Males and females
18 - 45 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.
Exclusion Criteria:
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
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Dickinson, PhD
Organizational Affiliation
University of Kent
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Do Heat and Moisture Exchange Mask Reduce EIB and Cough Severity in Asthma
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