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

May 28, 2022 updated by: Michael Koehle, University of British Columbia

Pulmonary and Vascular Adaptations to a 5-days Exercise Protocol in Ozone in Physically Active Individuals With Asthma and Exercise-induced Bronchoconstriction

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Recruiting
        • University of British Columbia
        • Principal Investigator:
          • Michael Koehle, MD, PhD
        • Contact:
      • Vancouver, British Columbia, Canada, V6T 1Z1
        • Recruiting
        • Environmental Physiology Laboratory
        • Principal Investigator:
          • Michael Koehle, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Ozone
Breathing 170ppb ozone
Behavioral: Exercise
Cycling at 60% of VO2max on a cycle ergometer for 30 minutes
Sham Comparator: 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.
Behavioral: Exercise
Cycling at 60% of VO2max on a cycle ergometer for 30 minutes
Other: Filtere Air
Breathing filtered air

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FEV1 from baseline to 10 minutes after exercise
Time Frame: Measured at baseline and 10 minutes after each exercise bout
Measurement of pulmonary function: forced exhaled volume in the first second (FEV1) in liters
Measured at baseline and 10 minutes after each exercise bout
Change in FVC from baseline to 10 minutes after exercise
Time Frame: Measured at baseline and 10 minutes after each exercise bout
Measurement of pulmonary function: forced vital capacity (FVC) in liters
Measured at baseline and 10 minutes after each exercise bout
Change in FEF25-75 from baseline to 10 minutes after exercise
Time Frame: Measured at baseline and 10 minutes after each exercise bout
Measurement of pulmonary function: forced expiratory flow at 25-75% of pulmonary volume in liters per second (L/s)
Measured at baseline and 10 minutes after each exercise bout

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pulse Wave Velocity (PWV) from baseline to 20 minutes after exercise
Time Frame: Measured at baseline and 20 minutes after each exercise bout
Velocity (in meters per second) at which the blood pressure pulse propagates through set points in the circulatory system
Measured at baseline and 20 minutes after each exercise bout
Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 5 minutes after exercise
Time Frame: Measured at baseline and 5 minutes after each exercise bout
Non-invasive airway inflammation biomarker (in part per billion, ppb)
Measured at baseline and 5 minutes after each exercise bout

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Michael Koehle, MD PhD, professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 28, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21-01183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Ozone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe