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

Primary Purpose

Asthma, Asthma, Exercise-Induced, Exercise Induced Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Ozone
Filtere Air
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma focused on measuring Ozone, Air pollution, Asthma, Exercise-induced bronchoconstriction

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Environmental Physiology LaboratoryRecruiting
  • University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ozone (O3) group

Filtered Air

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in FEV1 from baseline to 10 minutes after exercise
Measurement of pulmonary function: forced exhaled volume in the first second (FEV1) in liters
Change in FVC from baseline to 10 minutes after exercise
Measurement of pulmonary function: forced vital capacity (FVC) in liters
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)

Secondary Outcome Measures

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
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)

Full Information

First Posted
September 28, 2021
Last Updated
May 28, 2022
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05105529
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Asthma, Exercise-Induced, Exercise Induced Asthma, Exercise Induced Bronchospasm
Keywords
Ozone, Air pollution, Asthma, Exercise-induced bronchoconstriction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ozone (O3) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Filtered Air
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Cycling at 60% of VO2max on a cycle ergometer for 30 minutes
Intervention Type
Other
Intervention Name(s)
Ozone
Intervention Description
Breathing 170ppb ozone
Intervention Type
Other
Intervention Name(s)
Filtere Air
Intervention Description
Breathing filtered air
Primary Outcome Measure Information:
Title
Change in FEV1 from baseline to 10 minutes after exercise
Description
Measurement of pulmonary function: forced exhaled volume in the first second (FEV1) in liters
Time Frame
Measured at baseline and 10 minutes after each exercise bout
Title
Change in FVC from baseline to 10 minutes after exercise
Description
Measurement of pulmonary function: forced vital capacity (FVC) in liters
Time Frame
Measured at baseline and 10 minutes after each exercise bout
Title
Change in FEF25-75 from baseline to 10 minutes after exercise
Description
Measurement of pulmonary function: forced expiratory flow at 25-75% of pulmonary volume in liters per second (L/s)
Time Frame
Measured at baseline and 10 minutes after each exercise bout
Secondary Outcome Measure Information:
Title
Change in Pulse Wave Velocity (PWV) from baseline to 20 minutes after exercise
Description
Velocity (in meters per second) at which the blood pressure pulse propagates through set points in the circulatory system
Time Frame
Measured at baseline and 20 minutes after each exercise bout
Title
Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 5 minutes after exercise
Description
Non-invasive airway inflammation biomarker (in part per billion, ppb)
Time Frame
Measured at baseline and 5 minutes after each exercise bout

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patric O Gonçalves, BScPT
Phone
6048229331
Email
patricog@alumni.ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Koehle
Email
michael.koehle@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Koehle, MD PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Environmental Physiology Laboratory
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Koehle, MD, PhD
Phone
604 8229331
Email
michael.koehle@ubc.ca
First Name & Middle Initial & Last Name & Degree
Michael Koehle, MD, PhD
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Koehle, MD, PhD
Phone
(604) 822-9331
Email
michael.koehle@ubc.ca
First Name & Middle Initial & Last Name & Degree
Michael Koehle, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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