Clinical trial NCT02252302: Exercise in Air Pollution and Lung Health in Asthmatics
Official title: The Effects of Inhaled Beta-2-Agonists and Air Pollution on Lung Function and Athletic Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise-induced Bronchoconstriction
Air Pollution
Keywords: Exercise-induced bronchoconstriction
Air pollution
Exercise
Inhaled beta-2-agonist
Cognitive Function
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Academy of Sport and Exercise Medicine (CASEM)
name: Natural Sciences and Engineering Research Council, Canada
name: Fraser Basin Council
First posted: 2014-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: When exposed to air pollution, the asthma symptoms are aggravated and lung function is impaired. Due to high breathing rates and volumes, physically active individuals are at particular risk of lung health impairment due to the high breathing rates and volumes. Greater doses of air pollutants reach deeper areas in the lungs where they can trigger asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen even more, allowing the air pollutants to reach even deeper areas of the lung. With this study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and lung health in physically active asthmatics.


Eligibility criteria: Inclusion Criteria:

* mild-moderate asthmatics with controlled treatment (definition of "mild": percent fall index at eucapnic voluntary hyperpnea (EVH) test on screening day between 10-15%; "moderate": percent fall index at EVH test on screening day between 15 - 20%).
* men and non-pregnant women

Exclusion Criteria:

* any history of uncontrolled respiratory or cardiac disease
* pregnancy
* allergic reactions to lidocaine and salbutamol
* any recent infections or orthopaedic nasal issues/injuries that may interfere with the insertion of the catheter needed to assess expiratory flow limitation or work of breathing
* claustrophobia in small rooms, comparable to the air pollution chamber used for this study.
* English as a second language (ESL) - participants who are not able to understand the risk that may be associated with the participation in this study due to language difficulties after following the University of British Clinical Research Ethics Board Guidance Notes 13.2.1. (ESL participants will be given a consent form in the most appropriate language or an appropriate translator will be present during the initial consent process).

Primary outcomes:
measure: Change in rating of perceived exertion for breathing, dyspnea
timeFrame: Difference in perceived dyspnea between salbutamol and placebo exposure as well as polluted air and filtered air. Dyspnea ratings will be collected every 2.5min for a duration of 45min during the exercise test.
Secondary outcomes:
measure: Change in work of breathing (WOB) between filtered air and polluted air
timeFrame: work of breathing will be assessed every 2.5min for a time period of 45min during the exercise bout
Other outcomes:
measure: Change in spirometry (FEV1 and FVC) between filtered air and polluted air
timeFrame: Spirometry will be assessed at baseline and 45min after the start of the exercise bout.
measure: Change in cognitive function
timeFrame: Cognitive function will be assessed at baseline (prior to entering the air pollution chamber) and 45 min after the start of the exercise intervention.
measure: Retinal Imaging
timeFrame: The retina will be imaged at baseline (prior to entering the air pollution chamber) and 20 min after the completion of the exercise intervention.
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia, Environmental Physiology Laboratory
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Michael S Koehle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: