Asthma and/or Exercise Induced Bronchoconstriction, Ozone Air Pollution
Conditions
Keywords
Asthma, Exercise Induced Bronchoconstriction, Salbutamol, Ozone
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.
Interventions
DRUGSalbutamol
Inhaling 200ug of salbutamol
Inhaling placebo medication
OTHEROzone
Breathing 170ppb ozone
OTHERFiltered Air
Breathing filtered air
OTHERExercise
Cycling at 60% of VO2max on a cycle ergometer
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Drug condition (placebo or salbutamol) will be double blinded Air quality condition (ozone or filtered air) will be single blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measured Before and 30 Minutes After Exercise in Each 1 Day Condition | Measured before and 30 minutes after exercise in each 1 day condition | Measure of pulmonary function |
| Change in FVC From Baseline to 30 Minutes After Exercise | Measured before and 30 minutes after exercise in each 1 day condition | Measure of pulmonary function |
Countries
Canada
Participant flow
Pre-assignment details
Individuals without EIB were excluded. 23 tested positive for EIB, but only 18 were ultimately enrolled and scheduled for testing.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants who screened positive and included in the 4 testing bouts. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 18 Participants | — |
| Age, Continuous | 25.5 years STANDARD_DEVIATION 5.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 18 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Change in FVC From Baseline to 30 Minutes After Exercise
Measure of pulmonary function
Time frame: Measured before and 30 minutes after exercise in each 1 day condition
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercising in Ozone Following Salbutamol Inhalation | Change in FVC From Baseline to 30 Minutes After Exercise | .77 litres |
| Exercising in Filtered Air Following Salbutamol Inhalation | Change in FVC From Baseline to 30 Minutes After Exercise | .39 litres |
| Exercising in Ozone Following Placebo Inhalation | Change in FVC From Baseline to 30 Minutes After Exercise | -1.37 litres |
| Exercising in Filtered Air Following Placebo Inhalation | Change in FVC From Baseline to 30 Minutes After Exercise | -1.44 litres |
Primary
Measured Before and 30 Minutes After Exercise in Each 1 Day Condition
Measure of pulmonary function
Time frame: Measured before and 30 minutes after exercise in each 1 day condition
Population: Entire study population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercising in Ozone Following Salbutamol Inhalation | Measured Before and 30 Minutes After Exercise in Each 1 Day Condition | 6.98 litres |
| Exercising in Filtered Air Following Salbutamol Inhalation | Measured Before and 30 Minutes After Exercise in Each 1 Day Condition | 5.96 litres |
| Exercising in Ozone Following Placebo Inhalation | Measured Before and 30 Minutes After Exercise in Each 1 Day Condition | -1.38 litres |
| Exercising in Filtered Air Following Placebo Inhalation | Measured Before and 30 Minutes After Exercise in Each 1 Day Condition | -.35 litres |