Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.
The objectives of this study were to evaluate the effect of a one-year treatment with
inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of
exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The secondary purpose was to explore possible relationships between lung function changes
and occurrence of COPD exacerbations and to try to characterize these exacerbations.
This was a multicentre, randomised, double blind, parallel group, placebo-controlled, one
year study. It was designed to determine the effect of inhaled tiotropium treatment on
airflow obstruction (PEFR), incidence and severity of exacerbations in patients with COPD.
Following an initial 3-week screening period qualifying patients were randomized to either
tiotropium or placebo at Visit 2. Patients returned to the clinic at weeks 6 (Visit 3), 12
(Visit 4), 24 (Visit 5), 36 (Visit 6), 48 (Visit 7) and at Week 50 for the conclusion of the
trial (Visit 8). The patients received treatment daily for 48 weeks (336 days).
PEFR, as well as use of rescue medication and respiratory condition, were self-assessed by
patients and recorded every morning on a graphical diary card every morning. The graphical
presentation of these data was supposed to help investigators to detect exacerbations
occurring between two consecutive visits.
Details on hospitalizations due to COPD exacerbations were recorded in a special
hospitalization booklet.
Study Hypothesis:
The objectives of this study were to evaluate the effect of a one-year treatment with
inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of
exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The secondary purpose was to explore possible relationships between lung function changes
and occurrence of COPD exacerbations and to try to characterize these exacerbations.
Comparison(s):
Tiotropium 18 mcg once daily vs Placebo
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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