Skip to main content
OpenTrials
Completed

NCT Number: NCT01338311

Salbutamol Tolerance 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salbutamol

Drug

200mcg twice daily for a total of 7 doses

Placebo

Drug

200mcg twice a day for a total of 7 doses (3.5 days).

Primary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2011
Registry last updated
Jul 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.