Salbutamol Tolerance Onset

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: salbutamol; Drug: Placebo

• Registration Number: NCT01338311
• Lead Sponsor: University of Saskatchewan

Brief Summary

Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-17
• Study First Posted: 2011-04-19
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-19
• Last Update Posted: 2012-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• male or female
• 18 to 65 years of age
• non smoker
• beta agonist naive for at least 14 days
• baseline FEV1 at least 70% predicted
• no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1

Exclusion Criteria

• poorly controlled asthma
• pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
salbutamol	salbutamol	-
placebo	Placebo	200mcg twice daily for a total of 7 doses

Primary Outcome Measures

Name	Time	Method
Airway responsiveness as a measure of salbutamol bronchoprotection	ten minutes post 200mcg salbutamol on day 7	Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.
Airway responsiveness as a measure of bronchoprotection. The primary outcome is to determine the onset of this tolerance.	ten minutes post 200mcg salbutamol on day 5	Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada