Do Heat and Moisture Exchange Mask Reduce EIB and Cough Severity in Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302610
• Other study ID #: AUK-IG-2016-332
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: May 15, 2018

Study information

• Verified date: May 2016
• Source: University of Kent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 15, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma, Exercise-Induced

Intervention

Device:
• 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
• Sham treatment
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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Kent	Asthma UK, King's College Hospital NHS Trust, Royal Brompton & Harefield NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% fall in FEV1	Change in Forced Expiratory Volume in One Second from baseline to post exercise	30 minutes
Secondary	coughs per hour after EX	Number of coughs per hour in a 24 hour period after exercise	24 hours