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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
University of Kent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma, Exercise-Induced

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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