Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7376
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: patients inhale Tiotropium 18mcg once daily via HandiHaler and Placebo MDI twice daily arm 2: patients inhale Salmeterol 50mcg twice daily via MDI and Placebo HandiHaler once daily

Interventions: intervention 1: Tiotropium bromide intervention 2: Salmeterol intervention 3: Placebo Salmeterol intervention 4: Placebo Tiotropium
Intervention descriptions: intervention 1: 18 mcg/daily intervention 2: 100 mcg/daily intervention 3: Placebo identical to Salmeterol device intervention 4: Placebo identical to Tiotropium device

Protocol document: