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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: salbutamol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Salbutamol: Tolerance to Bronchoprotection vs. Methacholine: Time Course of Onset

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: salbutamol Drug: salbutamol
200mcg twice daily for a total of 7 doses
Placebo Comparator: placebo
200mcg twice daily for a total of 7 doses
 Drug: Placebo
200mcg twice a day for a total of 7 doses (3.5 days).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338311

Locations
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Donald W Cockcroft, MD University of Saskatchewan
  More Information

No publications provided by University of Saskatchewan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01338311     History of Changes
Other Study ID Numbers: BMC 10-226
Study First Received: April 1, 2011
Last Updated: July 19, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on June 17, 2013