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

May 8, 2023 updated by: Michael Koehle, University of British Columbia

Examining the Effect of Salbutamol Use in Asthma and/or Exercise Induced Bronchoconstriction Whilst Exercising in Ozone Air Pollution

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

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 Locations

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

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

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercising in ozone following salbutamol inhalation
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.
Drug: Salbutamol
Inhaling 200ug of salbutamol
Other: Ozone
Breathing 170ppb ozone
Other: Exercise
Cycling at 60% of VO2max on a cycle ergometer
Active Comparator: Exercising in filtered air following salbutamol inhalation
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.
Drug: Salbutamol
Inhaling 200ug of salbutamol
Other: Exercise
Cycling at 60% of VO2max on a cycle ergometer
Other: Filtered Air
Breathing filtered air
Placebo Comparator: Exercising in ozone following placebo inhalation
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.
Other: Ozone
Breathing 170ppb ozone
Other: Exercise
Cycling at 60% of VO2max on a cycle ergometer
Drug: Placebo medication
Inhaling placebo medication
Placebo Comparator: Exercising in filtered air following placebo inhalation
Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.
Other: Exercise
Cycling at 60% of VO2max on a cycle ergometer
Other: Filtered Air
Breathing filtered air
Drug: Placebo medication
Inhaling placebo medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 30 minutes after exercise
Time Frame: Measured before and 30 minutes after exercise in each condition
Biomarker for airway inflammation
Measured before and 30 minutes after exercise in each condition
Change in FEV1 from baseline to 30 minutes after exercise
Time Frame: Measured before and 30 minutes after exercise in each condition
Measure of pulmonary function
Measured before and 30 minutes after exercise in each condition
Change in FVC from baseline to 30 minutes after exercise
Time Frame: Measured before and 30 minutes after exercise in each condition
Measure of pulmonary function
Measured before and 30 minutes after exercise in each condition
Change in FEF25-75 from baseline to 30 minutes after exercise
Time Frame: Measured before and 30 minutes after exercise in each condition
Measure of pulmonary function
Measured before and 30 minutes after exercise in each condition

Collaborators and Investigators

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

Sponsor

University of British Columbia

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)

November 1, 2021

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 8, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21-01080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Any data shared will not contain any personal identifiers.

Drug and device information, study documents

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

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.

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