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Salbutamol Tolerance Onset

Information source: University of Saskatchewan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: salbutamol (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Saskatchewan

Official(s) and/or principal investigator(s):
Donald W Cockcroft, MD, Principal Investigator, Affiliation: University of Saskatchewan

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.

Clinical Details

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

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

Primary outcome:

Airway responsiveness as a measure of salbutamol bronchoprotection

Airway responsiveness as a measure of salbutamol bronchoprotection

Airway responsiveness as a measure of bronchoprotection. The primary outcome is to determine the onset of this tolerance.

Airway responsiveness as a measure of salbutamol bronchoprotection

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

University of Saskatchewan, Saskatoon, Saskatchewan S7N 0W8, Canada
Additional Information

Starting date: March 2011
Last updated: July 19, 2012

Page last updated: August 23, 2015

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