Salbutamol Tolerance Onset
Salbutamol: Tolerance to Bronchoprotection vs. Methacholine: Time Course of Onset
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Mar 2011
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJuly 20, 2012
July 1, 2012
1 year
April 1, 2011
July 19, 2012
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Study Arms (2)
salbutamol
ACTIVE COMPARATORplacebo
PLACEBO COMPARATOR200mcg twice daily for a total of 7 doses
Interventions
Eligibility Criteria
You may qualify if:
- male or female
- 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
You may not qualify if:
- poorly controlled asthma
- pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Publications (1)
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.
PMID: 23176887DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald W Cockcroft, MD
University of Saskatchewan
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2011
First Posted
April 19, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 20, 2012
Record last verified: 2012-07