Effects of Salmeterol on Walking Capacity in Patients With COPD

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00525564
First received: September 4, 2007
Last updated: September 5, 2007
Last verified: September 2007

September 4, 2007
September 5, 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
Complete list of historical versions of study NCT00525564 on ClinicalTrials.gov Archive Site
  • 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Placebo
    Placebo diskus inhalation powder
    Other Name: Placebo
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
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.
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00525564
SMS106875
No
Not Provided
Laval University
GlaxoSmithKline
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