Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease

Sponsor

University of Saskatchewan (Other)

Overall Status

Completed

CT.gov ID

NCT00440245

Collaborator

(none)

Enrollment

Location

Arm

40.9

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Asthma COPD	Drug: salbutamol	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bronchoprotection of Salbutamol in Asthma and COPD

Actual Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

methacholine PC20 dose shift [one hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

asthma or COPD

Exclusion Criteria:

asthma and COPD

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N0W8

Sponsors and Collaborators

University of Saskatchewan

Investigators

Principal Investigator: Donald Cockcroft, MD, University of Saskatchewan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Don Cockcroft, Professor, University of Saskatchewan

ClinicalTrials.gov Identifier:

NCT00440245

Other Study ID Numbers:

Bio-REB 06-231

First Posted:

Feb 26, 2007

Last Update Posted:

Mar 27, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Asthma

Albuterol

Study Results

No Results Posted as of Mar 27, 2020