Trial Outcomes & Findings for Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB) (NCT NCT05087693)
NCT ID: NCT05087693
Last Updated: 2025-03-14
Results Overview
Measure of pulmonary function
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
Measured before and 30 minutes after exercise in each 1 day condition
Results posted on
2025-03-14
Participant Flow
Individuals without EIB were excluded. 23 tested positive for EIB, but only 18 were ultimately enrolled and scheduled for testing.
Participant milestones
| Measure |
All Participants
Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer on four occasions in random order.
On one of the occasions they will exercise while inhaling 170ppb ozone after inhaling 200ug of salbutamol.
On one of the occasions they will exercise while inhaling 170ppb ozone after inhaling one puff of placebo.
On one of the occasions they will exercise while room air after inhaling 200ug of salbutamol.
On one of the occasions they will exercise while inhaling room air after inhaling one puff of placebo.
Exercise: Cycling at 60% of VO2max on a cycle ergometer
Due to the randomised nature there will be more than six possible sequences of these four exposures, thus as per guidance from clinical trials.gov we will use a single arm/group for the participant flow.
|
|---|---|
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Overall Study
STARTED
|
18
|
|
Overall Study
Ozone/Placebo
|
18
|
|
Overall Study
Ozone/Salbutamol
|
18
|
|
Overall Study
Clean Air/Placebo
|
18
|
|
Overall Study
Clean Air/Salbutamol
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=18 Participants
All participants who screened positive and included in the 4 testing bouts.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
|
Age, Continuous
|
25.5 years
STANDARD_DEVIATION 5.2 • n=18 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=18 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Measured before and 30 minutes after exercise in each 1 day conditionPopulation: Entire study population
Measure of pulmonary function
Outcome measures
| Measure |
Exercising in Ozone Following Salbutamol Inhalation
n=18 Participants
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.
Salbutamol: Inhaling 200ug of salbutamol
Ozone: Breathing 170ppb ozone
Exercise: Cycling at 60% of VO2max on a cycle ergometer
|
Exercising in Filtered Air Following Salbutamol Inhalation
n=18 Participants
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.
Salbutamol: Inhaling 200ug of salbutamol
Filtered Air: Breathing filtered air
Exercise: Cycling at 60% of VO2max on a cycle ergometer
|
Exercising in Ozone Following Placebo Inhalation
n=18 Participants
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.
Placebo medication: Inhaling placebo medication
Ozone: Breathing 170ppb ozone
Exercise: Cycling at 60% of VO2max on a cycle ergometer
|
Exercising in Filtered Air Following Placebo Inhalation
n=18 Participants
Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.
Placebo medication: Inhaling placebo medication
Filtered Air: Breathing filtered air
Exercise: Cycling at 60% of VO2max on a cycle ergometer
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|---|---|---|---|---|
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Measured Before and 30 Minutes After Exercise in Each 1 Day Condition
|
6.98 litres
Interval 5.25 to 8.71
|
5.96 litres
Interval 4.23 to 7.69
|
-1.38 litres
Interval -3.12 to 0.35
|
-.35 litres
Interval -2.08 to 1.39
|
PRIMARY outcome
Timeframe: Measured before and 30 minutes after exercise in each 1 day conditionMeasure of pulmonary function
Outcome measures
| Measure |
Exercising in Ozone Following Salbutamol Inhalation
n=18 Participants
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.
Salbutamol: Inhaling 200ug of salbutamol
Ozone: Breathing 170ppb ozone
Exercise: Cycling at 60% of VO2max on a cycle ergometer
|
Exercising in Filtered Air Following Salbutamol Inhalation
n=18 Participants
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.
Salbutamol: Inhaling 200ug of salbutamol
Filtered Air: Breathing filtered air
Exercise: Cycling at 60% of VO2max on a cycle ergometer
|
Exercising in Ozone Following Placebo Inhalation
n=18 Participants
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.
Placebo medication: Inhaling placebo medication
Ozone: Breathing 170ppb ozone
Exercise: Cycling at 60% of VO2max on a cycle ergometer
|
Exercising in Filtered Air Following Placebo Inhalation
n=18 Participants
Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.
Placebo medication: Inhaling placebo medication
Filtered Air: Breathing filtered air
Exercise: Cycling at 60% of VO2max on a cycle ergometer
|
|---|---|---|---|---|
|
Change in FVC From Baseline to 30 Minutes After Exercise
|
.77 litres
Interval -0.14 to 1.67
|
.39 litres
Interval -0.51 to 1.29
|
-1.37 litres
Interval -2.28 to -0.47
|
-1.44 litres
Interval -2.35 to -0.54
|
Adverse Events
Exercising in Ozone Following Salbutamol Inhalation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercising in Filtered Air Following Salbutamol Inhalation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercising in Ozone Following Placebo Inhalation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercising in Filtered Air Following Placebo Inhalation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place