Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect, of Tiotropium Inhalation Capsules on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD).
The objective of this study is to determine if tiotropium (Spiriva, Bromuro de Tiotropio) 18 mcg once daily by oral inhalation compared to placebo increases the magnitude of daily physical activity observed in COPD patients, measured using an accelerometer.
This is a 3 month, multicentre, randomised, double-blind, placebo controlled, parallel group
study to compare with placebo the long-term effect of tiotropium inhalation capsules on
daily physical activity in patients with COPD.
The drugs will be administered in the form of inhalation capsules of tiotropium or placebo,
taken once daily in the morning.
The record of daily physical activity using the accelerometer will be carried out at all
study visits other than Visit 1. The accelerometer will be used for the five day period,
from Thursday to Monday, closest to the corresponding visit.
The pulmonary function tests will be carried out at Visit 1 (screening visit), Visit 2
(baseline visit) and study visits (Visits 3 to 5) with the restrictions detailed at the
trial protocol.
Study Hypothesis:
The null hypothesis is that there is no difference between tiotropium (Spiriva) and placebo
regarding the magnitude of exercise measured with an accelerometer. The alternative
hypothesis is that there is a difference between tiotropium (Spiriva) and placebo regarding
the magnitude of exercise measured with an accelerometer.
Comparison(s):
The difference in physical activity measured in vector magnitude units (VMUs) by the
triaxial Stayhealthy RT3 accelerometer at the end of the three month treatment period
compared to placebo.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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