Effects of Salmeterol on Walking Capacity in Patients With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525564
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : September 6, 2007
Information provided by:
Laval University

September 4, 2007
September 6, 2007
September 6, 2007
May 2006
Not Provided
Endurance time during an endurance shuttle walk [ Time Frame: acute response (2.5 hours) following the administration of the active and comparison drug ]
Same as current
No Changes Posted
  • Dyspnea during endurance shuttle walk [ Time Frame: 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 ]
Same as current
Not Provided
Not Provided
Effects of Salmeterol on Walking Capacity in Patients With COPD
Effects of Salmeterol on Walking Capacity in Patients With COPD

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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Placebo
    Placebo diskus inhalation powder
  • Drug: Salmeterol diskus inhalation powder
    50 micrograms twice a day
    Other Name: Serevent
  • Placebo Comparator: A
    Placebo diskus
    Intervention: Drug: Placebo
  • Active Comparator: B
    Salmeterol diskus powder
    Intervention: Drug: Salmeterol diskus inhalation powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2006
Not Provided

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.
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Laval University
Principal Investigator: François Maltais, MD Laval University
Laval University
September 2007

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