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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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Placebo Drug: Salmeterol diskus inhalation powder Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Salmeterol on Walking Capacity in Patients With COPD
Study Start Date : May 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

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 Name: Serevent

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00525564

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Canada, Quebec
Hôpital Laval
Quebec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
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Principal Investigator: François Maltais, MD Laval University
Layout table for additonal information Identifier: NCT00525564    
Other Study ID Numbers: SMS106875
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: September 6, 2007
Last Verified: September 2007
Keywords provided by Laval University:
Chronic Obstructive Pulmonary Disease (COPD)
Endurance shuttle walking test
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action