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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05105529
• Other study ID #: H21-01183
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 2023

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: Patric O Gonçalves, BScPT
• Phone: 6048229331
• Email: patricog[@]alumni.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma, Exercise-Induced
• Bronchial Spasm
• Exercise Induced Asthma
• Exercise Induced Bronchospasm

Intervention

Behavioral:
• Exercise
Cycling at 60% of VO2max on a cycle ergometer for 30 minutes

Other:
• Ozone
Breathing 170ppb ozone
• Filtere Air
Breathing filtered air

Locations

Country	Name	City	State
Canada	Environmental Physiology Laboratory	Vancouver	British Columbia
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in Pulse Wave Velocity (PWV) from baseline to 20 minutes after exercise	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
Secondary	Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 5 minutes after exercise	Non-invasive airway inflammation biomarker (in part per billion, ppb)	Measured at baseline and 5 minutes after each exercise bout