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

NCT05105529 | Unknown

• 1 other identifier: H21-01183
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Ozone; Air pollution; Asthma; Exercise-induced bronchoconstriction

Outcome Measures

Primary Outcomes (3)

• Change in FEV1 from baseline to 10 minutes after exercise

  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

  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

  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 Outcomes (2)

• Change in Pulse Wave Velocity (PWV) from baseline to 20 minutes after exercise

  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

  Measured at baseline and 5 minutes after each exercise bout

Study Arms (2)

Ozone (O3) group

EXPERIMENTAL

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.

Behavioral: Exercise; Other: Ozone

Filtered Air

SHAM COMPARATOR

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; Other: Filtere Air

Interventions

Exercise BEHAVIORAL

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

Filtered Air; Ozone (O3) group

Ozone OTHER

Breathing 170ppb ozone

Ozone (O3) group

Filtere Air OTHER

Breathing filtered air

Filtered Air

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

Environmental Physiology Laboratory

Vancouver, British Columbia, V6T 1Z1, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

MeSH Terms

Conditions

Asthma; Asthma, Exercise-Induced

Interventions

Exercise; Ozone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Exercise-Induced Allergies

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Oxygen; Gases; Inorganic Chemicals

Study Officials

• Michael Koehle, MD PhD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patric O Gonçalves, BScPT

CONTACT

6048229331; patricog@alumni.ubc.ca

Michael Koehle

CONTACT

michael.koehle@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 3, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)