Asthma, Exercise-InducedNCT04302610
Do Heat and Moisture Exchange Mask Reduce EIB and Cough Severity in Asthma
A study testing Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA, in people with Asthma, Exercise-Induced and Asthma, run by University of Kent.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma, Exercise-Induced, Asthma
- What is being tested?
- Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA,
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 15 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
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
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.
Read the 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
- Conditions
- Asthma, Exercise-Induced, Asthma
- Being tested
- Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA,, Sham treatment
- Medical subject headings
- Asthma, Exercise-Induced, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| HME MASK | Experimental | During the Exercise, participants wore either an HME mask (MASK) (ColdAvenger® expedition balaclava, USA, www.coldavenger.com) Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
% fall in FEV1
Change in Forced Expiratory Volume in One Second from baseline to post exercise
Measured: 30 minutes
Secondary outcomes (1)
coughs per hour after EX
Number of coughs per hour in a 24 hour period after exercise
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Sep 2016
- Primary completion1 Apr 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, Exercise-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomised cross-over design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kent
- Sponsor type
- University, hospital or other
- Collaborators
- Asthma UK, Royal Brompton & Harefield NHS Foundation Trust, King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- John W Dickinson, PhD, Principal investigator, University of Kent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302610
- Sponsor's protocol ID
- AUK-IG-2016-332
- Status last verified
- May 2016
- First submitted
- 6 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04302610
- Acronym / sponsor ID
- AUK-IG-2016-332
- Conditions
- Asthma, Exercise-Induced, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of KentUniversity, hospital or other
- Collaborators
- Asthma UK, Royal Brompton & Harefield NHS Foundation Trust, King's College Hospital NHS Trust
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomised cross-over design
| Arm | Type | Receives |
|---|---|---|
| HME MASK | Experimental | Device: Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA,During the Exercise, participants wore either an HME mask (MASK) (ColdAvenger® expedition balaclava, USA, www.coldavenger.com) |
| SHAM mask | Sham comparator | Device: Sham treatmenta sham mask (SHAM) which was the same HME mask with holes cut across the entire ventilator cup and the ventilator removed |
| Control | No intervention | –No mask (CONT) wearing only the balaclava to which the HME and SHAM mask were attached. Mouth and face not covered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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:
- Metabolic diseases:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA,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 | Device | HME MASK |
| Sham treatmentSame 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 | Device | SHAM mask |
Primary outcome
% fall in FEV1
Time frame: 30 minutes
Change in Forced Expiratory Volume in One Second from baseline to post exercise
1 secondary outcome
coughs per hour after EX
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Dickinson, PhD principal investigator
University of Kent
Questions about this trial
What is this clinical trial studying?
A study testing Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA, in people with Asthma, Exercise-Induced and Asthma, run by University of Kent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% fall in FEV1 (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.