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Beta-2 Agonist
Salbutamol for Asthma
Phase 4
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured before and 30 minutes after exercise in each condition
Awards & highlights
Study Summary
This trial will study the effect of salbutamol on asthma & EIB symptoms during exercise in areas with high ozone pollution. Participants will exercise in 4 conditions with/without salbutamol & ozone.
Eligible Conditions
- Ozone Air Pollution
- Asthma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured before and 30 minutes after exercise in each condition
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured before and 30 minutes after exercise in each condition
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in FEF25-75 from baseline to 30 minutes after exercise
Change in FEV1 from baseline to 30 minutes after exercise
Change in FVC from baseline to 30 minutes after exercise
+1 moreSide effects data
From 2014 Phase 4 trial • 152 Patients • NCT019222712%
Nasopharyngitis
1%
Hypercholesterolaemia
1%
Acute myocardial infarction
1%
Myocardial infarction
1%
Condition aggravated
1%
Urinary tract infection
1%
Excoriation
1%
Headache
1%
Chronic obstructive pulmonary disease
1%
Cough
1%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
NVA237
Tiotropium
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Exercising in ozone following salbutamol inhalationExperimental Treatment3 Interventions
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.
Group II: Exercising in filtered air following salbutamol inhalationActive Control3 Interventions
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.
Group III: Exercising in ozone following placebo inhalationPlacebo Group3 Interventions
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.
Group IV: Exercising in filtered air following placebo inhalationPlacebo Group3 Interventions
Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salbutamol
FDA approved
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,986 Total Patients Enrolled
16 Trials studying Asthma
3,766 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to do your best during physical exercise.You can speak and understand English well enough to communicate effectively.You have asthma and/or exercise-induced bronchoconstriction (EIB).
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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