Adaptation to Ozone in Individuals With Asthma/Exercise-induced Bronchoconstriction

NCT ID: NCT05105529

Last Updated: 2022-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Asthma, Exercise-Induced Exercise Induced Asthma Exercise Induced Bronchospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Air quality condition (Ozone and filtered air) will be double-blinded; Participants will not be told at any time before the study completion to which group they are assigned (intervention or sham)

Study Groups

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Ozone (O3) group

Participants of the experimental group will perform sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone delivered continuously during each exercise session.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Cycling at 60% of VO2max on a cycle ergometer for 30 minutes

Ozone

Intervention Type OTHER

Breathing 170ppb ozone

Filtered Air

Participants of the sham group will also perform sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer similar to intervention. However, only in this group, the ozone generator will not be activated so that just filtered air will be delivered to the participant while performing each exercise session.

Group Type SHAM_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Cycling at 60% of VO2max on a cycle ergometer for 30 minutes

Filtere Air

Intervention Type OTHER

Breathing filtered air

Interventions

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Exercise

Cycling at 60% of VO2max on a cycle ergometer for 30 minutes

Intervention Type BEHAVIORAL

Ozone

Breathing 170ppb ozone

Intervention Type OTHER

Filtere Air

Breathing filtered air

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Michael Koehle

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Koehle, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Environmental Physiology Laboratory

Vancouver, British Columbia, Canada

Site Status RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Patric O Gonçalves, BScPT

Role: CONTACT

6048229331

Michael Koehle

Role: CONTACT

Facility Contacts

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Michael Koehle, MD, PhD

Role: primary

604 8229331

Michael Koehle, MD, PhD

Role: primary

(604) 822-9331

Other Identifiers

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H21-01183

Identifier Type: -

Identifier Source: org_study_id

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