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

Sponsor

University of British Columbia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05087693

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma and/or Exercise Induced Bronchoconstriction Ozone Air Pollution	Drug: Salbutamol Drug: Placebo medication Other: Ozone Other: Filtered Air Other: Exercise	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Drug condition (placebo or salbutamol) will be double blinded Air quality condition (ozone or filtered air) will be single blinded

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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: Filtered Air Breathing filtered air Other: Exercise Cycling at 60% of VO2max on a cycle ergometer
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.	Drug: Placebo medication Inhaling placebo medication Other: Ozone Breathing 170ppb ozone Other: Exercise Cycling at 60% of VO2max on a cycle ergometer
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.	Drug: Placebo medication Inhaling placebo medication Other: Filtered Air Breathing filtered air Other: Exercise Cycling at 60% of VO2max on a cycle ergometer

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Environmental Physiology Laboratory	Vancouver	British Columbia	Canada	V6T 1Z1

Sponsors and Collaborators

University of British Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Koehle, Professor, University of British Columbia

ClinicalTrials.gov Identifier:

NCT05087693

Other Study ID Numbers:

H21-01080

First Posted:

Oct 21, 2021

Last Update Posted:

Oct 21, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Michael Koehle, Professor, University of British Columbia

Asthma

Exercise Induced Bronchoconstriction

Salbutamol

Ozone

Additional relevant MeSH terms:

Asthma

Albuterol

Study Results

No Results Posted as of Oct 21, 2021