Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Salbutamol Tolerance Onset

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01338311
First received: April 1, 2011
Last updated: July 19, 2012
Last verified: July 2012

April 1, 2011
July 19, 2012
March 2011
March 2012   (final data collection date for primary outcome measure)
  • Airway responsiveness as a measure of salbutamol bronchoprotection [ Time Frame: ten minutes post 200mcg salbutamol on day 1 ] [ Designated as safety issue: No ]
    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 salbutamol bronchoprotection [ Time Frame: ten minutes post 200mcg salbutamol on day 3 ] [ Designated as safety issue: No ]
    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. [ Time Frame: ten minutes post 200mcg salbutamol on day 5 ] [ Designated as safety issue: No ]
    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 salbutamol bronchoprotection [ Time Frame: ten minutes post 200mcg salbutamol on day 7 ] [ Designated as safety issue: No ]
    Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.
Airway responsiveness to methacholine as a measure of salbutamol bronchoprotection [ Time Frame: ten minutes post 200mcg salbutamol on days 1, 3, 5 and 7 ] [ Designated as safety issue: No ]
Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance. Methacholine bronchoprovocation (i.e. methacholine PC20) will be conducted following the first, third, fifth and seventh doses of salbutamol.
Complete list of historical versions of study NCT01338311 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Salbutamol Tolerance Onset
Salbutamol: Tolerance to Bronchoprotection vs. Methacholine: Time Course of Onset

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Asthma
  • Drug: salbutamol
    200mcg twice daily for a total of 7 doses
  • Drug: Placebo
    200mcg twice a day for a total of 7 doses (3.5 days).
  • Active Comparator: salbutamol
    Intervention: Drug: salbutamol
  • Placebo Comparator: placebo
    200mcg twice daily for a total of 7 doses
    Intervention: Drug: Placebo
Stewart SL, Martin AL, Davis BE, Cockcroft DW. Salbutamol tolerance to bronchoprotection: course of onset. Ann Allergy Asthma Immunol. 2012 Dec;109(6):454-7. doi: 10.1016/j.anai.2012.08.003. Epub 2012 Aug 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01338311
BMC 10-226
No
University of Saskatchewan
University of Saskatchewan
Not Provided
Principal Investigator: Donald W Cockcroft, MD University of Saskatchewan
University of Saskatchewan
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP