Salbutamol Tolerance Onset

Asthma Clinical Trial

Official title:

Salbutamol: Tolerance to Bronchoprotection vs. Methacholine: Time Course of Onset

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338311
• Other study ID #: BMC 10-226
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2011
• Last updated: July 19, 2012
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2012
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• salbutamol
200mcg twice daily for a total of 7 doses
• Placebo
200mcg twice a day for a total of 7 doses (3.5 days).

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway responsiveness as a measure of salbutamol bronchoprotection	Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.	ten minutes post 200mcg salbutamol on day 1	No
Primary	Airway responsiveness as a measure of salbutamol bronchoprotection	Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.	ten minutes post 200mcg salbutamol on day 3	No
Primary	Airway responsiveness as a measure of bronchoprotection. The primary outcome is to determine the onset of this tolerance.	Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.	ten minutes post 200mcg salbutamol on day 5	No
Primary	Airway responsiveness as a measure of salbutamol bronchoprotection	Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.	ten minutes post 200mcg salbutamol on day 7	No