Salbutamol Tolerance Onset

July 19, 2012 updated by: University of Saskatchewan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway responsiveness as a measure of salbutamol bronchoprotection
Time Frame: ten minutes post 200mcg salbutamol on day 1
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
Time Frame: ten minutes post 200mcg salbutamol on day 3
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.
Time Frame: ten minutes post 200mcg salbutamol on day 5
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
Time Frame: ten minutes post 200mcg salbutamol on day 7
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 17, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMC 10-226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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