Clinical trial NCT05105529: Adaptation to Ozone in Individuals With Asthma/Exercise-induced Bronchoconstriction
Official title: Pulmonary and Vascular Adaptations to a 5-days Exercise Protocol in Ozone in Physically Active Individuals With Asthma and Exercise-induced Bronchoconstriction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Asthma, Exercise-Induced
Exercise Induced Asthma
Exercise Induced Bronchospasm
Keywords: Ozone
Air pollution
Asthma
Exercise-induced bronchoconstriction
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers found that impairments in the cardiopulmonary system caused by acute exposure to ozone were outweighed by repeated exposures to ozone. The goal of this study is to confirm there will be an adaptation similar to what was previously proved but in individuals with asthma and exercise-induced bronchoconstriction (EIB). The purpose is to examine adaptive responses in a randomized cross-over trial in which physically active individuals will perform submaximal exercise on five days in ozone and filtered air exposures separated by a washout period.


Eligibility criteria: Inclusion Criteria:

* Recreationally active individuals
* Diagnosed asthma and/or mild exercise-induced bronchoconstriction: defined by an FEV1 fall equal to or greater than 10% but lower than 25% in the eucapnic hyperventilatory test.
* Able to securely perform a maximal exercise test (responded 'no' to all questions on the PAR-Q+ questionnaire)
* Able to communicate in English

Exclusion Criteria:

* Diagnosed with any cardiorespiratory or vascular diseases
* Pregnant or potentially pregnant
* Non-smoking
* Lower limb musculoskeletal injury or lower limb limitation to cycle on a bicycle ergometer
* Recent respiratory symptoms or upper tract infection within 4 weeks
* On vitamin (e.g., C or E) supplementation

Primary outcomes:
measure: Change in FEV1 from baseline to 10 minutes after exercise
timeFrame: Measured at baseline and 10 minutes after each exercise bout
measure: Change in FVC from baseline to 10 minutes after exercise
timeFrame: Measured at baseline and 10 minutes after each exercise bout
measure: Change in FEF25-75 from baseline to 10 minutes after exercise
timeFrame: Measured at baseline and 10 minutes after each exercise bout
Secondary outcomes:
measure: Change in Pulse Wave Velocity (PWV) from baseline to 20 minutes after exercise
timeFrame: Measured at baseline and 20 minutes after each exercise bout
measure: Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 5 minutes after exercise
timeFrame: Measured at baseline and 5 minutes after each exercise bout
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Environmental Physiology Laboratory
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Professor
name: Michael Koehle, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: