Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Tiotropium on Walking Capacity in Patients With COPD
This study was designed to test the following hypothesis:
A) The acute and long-term (3 weeks) bronchodilator-induced changes in exercise tolerance
and in the physiological response during the endurance shuttle walk will be greater with
tiotropium compared to placebo in COPD patients.
B) Three weeks of bronchodilation will be associated with increase activity of daily living
as evaluated using the London Chest Activity Daily Living scale.
Objectives:
The purpose of this study is to compare the acute bronchodilator-induced changes in exercise
tolerance during the endurance shuttle walk between tiotropium and placebo in COPD patients.
Also, it will evaluate the physiological response (VE, VO2, VCO2, and heart rate) during the
endurance shuttle walk in patients with COPD patients. Finally, it will compare the
long-term (3 weeks) bronchodilator-induced changes in exercise tolerance during the
endurance shuttle walk between tiotropium and placebo in COPD patients and evaluate the
impact of long-term (3 weeks) bronchodilation on activity of daily living evaluated using
the London Chest Activity Daily Living scale.
Methods:
This will be a double-blind, randomized and parallel-group study. Due to the long action
duration of tiotropium (up to 4 weeks), a cross-over design, as we used in our ipratropium
versus placebo study, is not appropriate in the present study. The study will require five
visits at the Centre de recherche de l'Hopital Laval. The first visit will include review of
the consent form, pulmonary function testing, and a maximal incremental shuttle walk. The
following two visits (Visit 2 and 3) will be used to familiarize the participants to the
shuttle endurance walking test. Salbutamol and ipratropium bromide will be stopped 6 hours
prior to these visits while the remaining medication allowed during the study period (see
below) will be continued as prescribed. The goal of the familiarization will be to reduce
the learning effect that typically occurs when an individual completes the same endurance
test several times 3. On visit 4, patients will be randomized to receive one of the two
treatments: placebo or tiotropium 18 ug (Spiriva) using the handihaler device. Pulmonary
function testing will then be performed and the London Chest Activity Daily Living scale
will be administered. Two hours following the inhalation of the first study dose, pulmonary
function testing will be repeated and the patients will perform an endurance shuttle walk.
They will be provided enough medication for the study duration and discharged. The same
procedure as Visit 4 will be completed three weeks later, on visit 5.
Data analysis:
The main outcome will be endurance time at day 21. This variable will be compared between
the two treatment arms using an unpaired t-test. The endurance time at day 0 will also be
compared between the two treatment arms using the same procedure. 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. The two familiarization endurance shuttle walk tests
performed at day -10 and day -5 will be used to evaluate the test-retest variability of this
procedure.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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