Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

February 22, 2007

Last Updated Date

July 24, 2009

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

methacholine PC20 dose shift [ Time Frame: one hour ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

methacholine PC20 dose shift

Change History

Complete list of historical versions of study NCT00440245 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease

Official Title ^ICMJE

Bronchoprotection of Salbutamol in Asthma and COPD

Brief Summary

This study will investigate potential differences in how two puffs of salbutamol protects airway smooth muscle from contracting in people with asthma and chronic obstructive pulmonary disease (COPD).

Detailed Description

In asthma, the administration (inhalation) of a selective β2 receptor agonist (e.g. salbutamol), prior to methacholine challenge has been shown to shift the dose response curve to the right and "bronchoprotect" the airway against airway smooth muscle contraction. The extent of β2 receptor agonist bronchoprotection in COPD is unknown.

Airway hyperresponsiveness (AHR) to direct acting agents such as histamine and methacholine is a feature of both asthma and COPD. In asthma, the abnormality leading to AHR is believed to be due to changes in airway smooth muscle (e.g. hypertrophy, hyperplasia, contractile apparatus) whereas in COPD the AHR is likely due to structural or geometric changes.

The investigators hypothesize that the bronchoprotection afforded by salbutamol against methacholine challenge will be greater in asthma than in COPD due to differences in underlying airway abnormalities.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Asthma
COPD

Intervention ^ICMJE

Drug: salbutamol

Study Arms / Comparison Groups

Other: There are two groups, asthma and COPD, which are being compared with respect to bronchoprotection from an active treatment (salbutamol).

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

asthma or COPD

Exclusion Criteria:

asthma and COPD

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Beth Davis, BSc

306-966-8290

beth.davis@usask.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00440245

Responsible Party

Dr. Donald Cockcroft, University of Saskatchewan

Study ID Numbers ^ICMJE

Bio-REB 06-231

Study Sponsor ^ICMJE

University of Saskatchewan

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Donald Cockcroft, MD

University of Saskatchewan

Information Provided By

University of Saskatchewan

Verification Date

July 2009

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