Effects of Salmeterol on Walking Capacity in Patients With COPD
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Placebo Drug: Salmeterol diskus inhalation powder |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Effects of Salmeterol on Walking Capacity in Patients With COPD |
- Endurance time during an endurance shuttle walk [ Time Frame: acute response (2.5 hours) following the administration of the active and comparison drug ]
- 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 ]
| Enrollment: | 28 |
| Study Start Date: | May 2006 |
| Study Completion Date: | October 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
Placebo diskus
|
Drug: Placebo
Placebo diskus inhalation powder
Other Name: Placebo
|
|
Active Comparator: B
Salmeterol diskus powder
|
Drug: Salmeterol diskus inhalation powder
50 micrograms twice a day
Other Name: Serevent
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00525564 History of Changes |
| Other Study ID Numbers: | SMS106875 |
| Study First Received: | September 4, 2007 |
| Last Updated: | September 5, 2007 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Laval University:
|
Chronic Obstructive Pulmonary Disease (COPD) Exercise Endurance shuttle walking test Bronchodilation Salmeterol |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Salmeterol Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013