Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled
 study.

 Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of
 either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the
 free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat®
 inhaler. The purpose is to show non-inferiority between the FDC and the free combination of
 tiotropium and olodaterol in patients with COPD.
Inclusion criteria:

 -  Male or female patients.

 -  Patients 40 years of age or older.

 -  Patients with a smoking history > 10 pack years.

 -  Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one
 second) >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced
 Vital Capacity) <70% at screening.

 -  Symptomatic patients with CAT (COPD Assessment Test TM) score >= 10 at screening.

 -  Further inclusion criteria apply.

 Exclusion criteria:

 -  COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks
 prior to screening.

 -  Patients with a current diagnosis of asthma.

 -  Further exclusion criteria apply.