Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercising in ozone following salbutamol inhalation | Experimental | 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. |
|
| Exercising in filtered air following salbutamol inhalation | Active Comparator | 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. |
|
| Exercising in ozone following placebo inhalation | Placebo Comparator | 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. |
|
| Exercising in filtered air following placebo inhalation | Placebo Comparator | Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol | Drug | Inhaling 200ug of salbutamol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measured Before and 30 Minutes After Exercise in Each 1 Day Condition | Measure of pulmonary function | Measured before and 30 minutes after exercise in each 1 day condition |
| Change in FVC From Baseline to 30 Minutes After Exercise | Measure of pulmonary function | Measured before and 30 minutes after exercise in each 1 day condition |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Environmental Physiology Laboratory | Vancouver | British Columbia | V6T 1Z1 | Canada |
Any data shared will not contain any personal identifiers.
Not provided
Not provided
Not provided
Not provided
Individuals without EIB were excluded. 23 tested positive for EIB, but only 18 were ultimately enrolled and scheduled for testing.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2022 |
Not provided
Not provided
Not provided
Not provided
Drug condition (placebo or salbutamol) will be double blinded Air quality condition (ozone or filtered air) will be single blinded
| Placebo medication | Drug | Inhaling placebo medication |
|
| Ozone | Other | Breathing 170ppb ozone |
|
| Filtered Air | Other | Breathing filtered air |
|
| Exercise | Other | Cycling at 60% of VO2max on a cycle ergometer |
|
| Ozone/Placebo |
|
| Ozone/Salbutamol |
|
| Clean Air/Placebo |
|
| Clean Air/Salbutamol |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants who screened positive and included in the 4 testing bouts. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measured Before and 30 Minutes After Exercise in Each 1 Day Condition | Measure of pulmonary function | Entire study population | Posted | Mean | 95% Confidence Interval | litres | Measured before and 30 minutes after exercise in each 1 day condition |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Change in FVC From Baseline to 30 Minutes After Exercise | Measure of pulmonary function | Posted | Mean | 95% Confidence Interval | litres | Measured before and 30 minutes after exercise in each 1 day condition |
|
Over the period from recruitment to completion of data collection for each individual. Five visits total over a period of approximately 10 days to 6 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Salbutamol: Inhaling 200ug of salbutamol Ozone: Breathing 170ppb ozone Exercise: Cycling at 60% of VO2max on a cycle ergometer | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | 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. Salbutamol: Inhaling 200ug of salbutamol Filtered Air: Breathing filtered air Exercise: Cycling at 60% of VO2max on a cycle ergometer | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | 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. Placebo medication: Inhaling placebo medication Ozone: Breathing 170ppb ozone Exercise: Cycling at 60% of VO2max on a cycle ergometer | 0 | 18 | 0 | 18 | 0 | 18 |
| EG003 | 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. Placebo medication: Inhaling placebo medication Filtered Air: Breathing filtered air Exercise: Cycling at 60% of VO2max on a cycle ergometer | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Koehle | UNiversity of BRitish COlumbia | 8229331 | michael.koehle@ubc.ca |
| Dec 9, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 14, 2022 | Apr 4, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D010126 | Ozone |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D010100 | Oxygen |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
| >=65 years |
|
| OG003 | 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. Placebo medication: Inhaling placebo medication Filtered Air: Breathing filtered air Exercise: Cycling at 60% of VO2max on a cycle ergometer |
|
|