Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Saskatchewan
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan Identifier:
First received: February 22, 2007
Last updated: December 4, 2014
Last verified: December 2014

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).

Condition Intervention
Drug: salbutamol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bronchoprotection of Salbutamol in Asthma and COPD

Resource links provided by NLM:

Further study details as provided by University of Saskatchewan:

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

Estimated Enrollment: 20
Study Start Date: February 2007
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
There are two groups, asthma and COPD, which are being compared with respect to bronchoprotection from an active treatment (salbutamol).
Drug: salbutamol
200 micrograms salbutamol from MDI

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • asthma or COPD

Exclusion Criteria:

  • asthma and COPD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00440245

Contact: Beth Davis, PhD 306-966-8290

Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N0W8
Contact: Beth Davis, PhD    306-966-8291   
Principal Investigator: Donald Cockcroft, MD         
Sponsors and Collaborators
University of Saskatchewan
Principal Investigator: Donald Cockcroft, MD University of Saskatchewan
  More Information

No publications provided

Responsible Party: Don Cockcroft, Professor, University of Saskatchewan Identifier: NCT00440245     History of Changes
Other Study ID Numbers: Bio-REB 06-231
Study First Received: February 22, 2007
Last Updated: December 4, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents processed this record on February 25, 2015