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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured before and 30 minutes after exercise in each condition for reporting.

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 more

Side effects data

From 2014 Phase 4 trial • 152 Patients • NCT01922271

Nasopharyngitis

Myocardial infarction

Hypercholesterolaemia

Condition aggravated

Acute myocardial infarction

Urinary tract infection

Excoriation

Headache

Chronic obstructive pulmonary disease

Cough

Dyspnoea

100%

80%

60%

40%

20%

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

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