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Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)

Primary Purpose

Asthma and/or Exercise Induced Bronchoconstriction, Ozone Air Pollution

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Salbutamol
Placebo medication
Ozone
Filtered Air
Exercise
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 and/or Exercise Induced Bronchoconstriction focused on measuring Asthma, Exercise Induced Bronchoconstriction, Salbutamol, Ozone

Eligibility Criteria

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

Inclusion Criteria:

  • Have asthma and/or EIB
  • Able to perform maximal exercise
  • Able to communicate sufficiently using the English language

Exclusion Criteria:

  • Allergic to salbutamol (also known as Ventolin)
  • Pregnant or potentially pregnant
  • Have a history of smoking
  • Had an upper respiratory tract infection within the last 4 weeks
  • Have a chronic respiratory disease other than asthma or EIB

Sites / Locations

  • Environmental Physiology LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Exercising in ozone following salbutamol inhalation

Exercising in filtered air following salbutamol inhalation

Exercising in ozone following placebo inhalation

Exercising in filtered air following placebo inhalation

Arm Description

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.

Outcomes

Primary Outcome Measures

Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 30 minutes after exercise
Biomarker for airway inflammation
Change in FEV1 from baseline to 30 minutes after exercise
Measure of pulmonary function
Change in FVC from baseline to 30 minutes after exercise
Measure of pulmonary function
Change in FEF25-75 from baseline to 30 minutes after exercise
Measure of pulmonary function

Secondary Outcome Measures

Full Information

First Posted
September 28, 2021
Last Updated
May 8, 2023
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05087693
Brief Title
Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)
Official Title
Examining the Effect of Salbutamol Use in Asthma and/or Exercise Induced Bronchoconstriction Whilst Exercising in Ozone Air Pollution
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Salbutamol use is increased in areas with high levels of ozone pollution and the potential consequences of this are not well known. The purpose of this study is to examine the effect of salbutamol on lung function and inflammation in people with asthma and/or EIB exercising in ozone air pollution. To examine this, we are planning a randomized cross over trial where people with asthma and/or EIB complete sub maximal exercise in four conditions on four separate days. The four condition are: ozone + salbutamol, filtered air + salbutamol, ozone + placebo medication, and filtered air + placebo medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma and/or Exercise Induced Bronchoconstriction, Ozone Air Pollution
Keywords
Asthma, Exercise Induced Bronchoconstriction, Salbutamol, Ozone

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Drug condition (placebo or salbutamol) will be double blinded Air quality condition (ozone or filtered air) will be single blinded
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercising in ozone following salbutamol inhalation
Arm Type
Experimental
Arm Description
Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.
Arm Title
Exercising in filtered air following salbutamol inhalation
Arm Type
Active Comparator
Arm Description
Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.
Arm Title
Exercising in ozone following placebo inhalation
Arm Type
Placebo Comparator
Arm Description
Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.
Arm Title
Exercising in filtered air following placebo inhalation
Arm Type
Placebo Comparator
Arm Description
Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Intervention Description
Inhaling 200ug of salbutamol
Intervention Type
Drug
Intervention Name(s)
Placebo medication
Intervention Description
Inhaling placebo medication
Intervention Type
Other
Intervention Name(s)
Ozone
Intervention Description
Breathing 170ppb ozone
Intervention Type
Other
Intervention Name(s)
Filtered Air
Intervention Description
Breathing filtered air
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Cycling at 60% of VO2max on a cycle ergometer
Primary Outcome Measure Information:
Title
Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 30 minutes after exercise
Description
Biomarker for airway inflammation
Time Frame
Measured before and 30 minutes after exercise in each condition
Title
Change in FEV1 from baseline to 30 minutes after exercise
Description
Measure of pulmonary function
Time Frame
Measured before and 30 minutes after exercise in each condition
Title
Change in FVC from baseline to 30 minutes after exercise
Description
Measure of pulmonary function
Time Frame
Measured before and 30 minutes after exercise in each condition
Title
Change in FEF25-75 from baseline to 30 minutes after exercise
Description
Measure of pulmonary function
Time Frame
Measured before and 30 minutes after exercise in each condition

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: Have asthma and/or EIB Able to perform maximal exercise Able to communicate sufficiently using the English language Exclusion Criteria: Allergic to salbutamol (also known as Ventolin) Pregnant or potentially pregnant Have a history of smoking Had an upper respiratory tract infection within the last 4 weeks Have a chronic respiratory disease other than asthma or EIB
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ben Stothers, BKIN
Phone
604 240 7188
Email
bennettstothers@gmail.com
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
604 788 7268
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
IPD Sharing Plan Description
Any data shared will not contain any personal identifiers.

Learn more about this trial

Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)

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