Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study).
This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group
trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50
mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a
52-week randomised treatment phase. Patients who withdraw prematurely from trial medication
will be encouraged to remain in the trial and participate in follow-up telephone contacts
until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first
dose of randomised treatment). The phone calls will be made at all scheduled visits.
The primary objective of this study is to compare the effect of tiotropium (18 mcg)
inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD
exacerbations.
The primary endpoint is time to first COPD exacerbation during the 52 week randomised
treatment period. A COPD exacerbation will be defined as a complex of respiratory events /
symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing,
dyspnoea or chest tightness with at least one symptom lasting at least three days requiring
treatment with antibiotics and/or systemic steroids and/or hospitalisation.
The onset of an exacerbation is defined as the onset of the first new or increased reported
symptom. The end of the exacerbation should be recorded as defined by the investigator.
Only COPD exacerbations with onset during randomised treatment will be included in the
analysis.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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