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Beta-2 Agonist
Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)
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
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is testing how well salbutamol helps people with asthma or EIB when they exercise in polluted air. The study will compare lung function and inflammation under different conditions, including with and without salbutamol and in both polluted and clean air. Salbutamol has been shown to be effective in reducing exercise-induced bronchoconstriction (EIB) and improving lung function in asthmatic patients.
Eligible Conditions
- Asthma
- Ozone Air Pollution
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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%
Myocardial infarction
1%
Hypercholesterolaemia
1%
Condition aggravated
1%
Acute myocardial infarction
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
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
1,472 Previous Clinical Trials
2,489,590 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.