Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD

A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (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.