Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants.
Verified October 2013 by University of Saskatchewan
Sponsor:
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00440245
First received: February 22, 2007
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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
Asthma
COPD
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 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
salbutamol
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.

  Eligibility

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

Inclusion Criteria:

  • asthma or COPD

Exclusion Criteria:

  • asthma and COPD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440245

Contacts
Contact: Beth Davis, PhD 306-966-8290 beth.davis@usask.ca

Locations
Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N0W8
Contact: Beth Davis, PhD    306-966-8291    beth.davis@usask.ca   
Principal Investigator: Donald Cockcroft, MD         
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Donald Cockcroft, MD University of Saskatchewan
  More Information

No publications provided

Responsible Party: Don Cockcroft, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00440245     History of Changes
Other Study ID Numbers: Bio-REB 06-231
Study First Received: February 22, 2007
Last Updated: October 31, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Asthma
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract 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 April 17, 2014