Effects of Salmeterol on Walking Capacity in Patients With COPD

September 5, 2007 updated by: Laval University

This study was designed to test the following hypothesis:

The acute changes in exercise tolerance during the endurance shuttle walk will be greater with salmeterol compared to placebo in patients with chronic obstructive pulmonary disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Little is known about the responsiveness of the endurance shuttle walking test (ESWT) to pharmacotherapy in patients with chronic obstructive pulmonary disease (COPD). This exercise testing modality needs to be further investigated because of its relevance for activity of daily living.

Objective: To evaluate, in patients with COPD, the responsiveness of the ESWT to detect improvement in walking performance after single dose of salmeterol.

Methods: In a randomised, double-blind, placebo-controlled, crossover study, 20 patients with COPD will perform, on two separate days, an ESWT at 80% of peak capacity, 2 hours after inhaling either a placebo or 50µg of salmeterol. Cardiorespiratory parameters will be monitored breath-by-breath during each walking test with a portable telemetric gas analyzer (Oxycom Mobile, Jaeger, Germany). Inspiratory capacities and Borg ratings for dyspnea were obtained every other minute throughout the tests.

Planned analysis. The main outcome will be endurance time. This variable will be compared between the two treatment arms using a paired t test. The time course of the cardiorespiratory parameters and dyspnea over time will be compared between the two exercise modalities. Comparisons will be done using a repeated measure design (ANOVA). Significance level will be set at a p value of 0.05.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G5
        • Hôpital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > 50 years
  • smoking history > 10 packs/year
  • FEV1 < 70% of predicted and FEV1/FVC < 70%.

Exclusion Criteria:

  • respiratory exacerbation within the 2 months preceding the study
  • history of asthma
  • significant O2 desaturation (SaO2 < 85%) at rest or during exercise
  • presence of another pathology that could influence exercise tolerance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A
Placebo diskus
Drug: Placebo
Placebo diskus inhalation powder
Active Comparator: B
Salmeterol diskus powder
Drug: Salmeterol diskus inhalation powder
50 micrograms twice a day
Other Names:
  • Serevent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endurance time during an endurance shuttle walk
Time Frame: acute response (2.5 hours) following the administration of the active and comparison drug
acute response (2.5 hours) following the administration of the active and comparison drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Dyspnea during endurance shuttle walk
Time Frame: acute response following the administration of the study medication
acute response following the administration of the study medication
cardio-respiratory responses during an endurance shutlle walk
Time Frame: acute response following the administration of the study medication
acute response following the administration of the study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (Estimate)

September 6, 2007

Study Record Updates

Last Update Posted (Estimate)

September 6, 2007

Last Update Submitted That Met QC Criteria

September 5, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMS106875

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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