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OpenTrials
Completed

NCT Number: NCT00525564

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo diskus inhalation powder

Salmeterol diskus inhalation powder

Drug

50 micrograms twice a day

Other names: Serevent

Primary outcomes

  1. Endurance time during an endurance shuttle walk

    Time frame: acute response (2.5 hours) following the administration of the active and comparison drug

Secondary outcomes

  1. Dyspnea during endurance shuttle walk

    Time frame: acute response following the administration of the study medication

  2. cardio-respiratory responses during an endurance shutlle walk

    Time frame: acute response following the administration of the study medication

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2006
Study completion
2006
First posted
Sep 6, 2007
Registry last updated
Sep 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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