Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients suffering from Chronic Obstructive Pulmonary Disease

INTERVENTION: Product Name: Tiotropium 1.25µg/Olodaterol 2.5µg Product Code: Ba 679/BI 1744 Pharmaceutical Form: Inhalation solution INN or Proposed INN: tiotropium Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1.25‐ INN or Proposed INN: olodaterol Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.5‐ Product Name: Tiotropium 2.5µg/Olodaterol 2.5µg Product Code: Ba 679/BI 1744 Pharmaceutical Form: Inhalation solution INN or Proposed INN: tiotropium Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.5‐ INN or Proposed INN: olodaterol Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.5‐ Trade Name: Spiriva Respimat 2.5 µg Product Name: Spiriva Respimat 2.5 µg Pharmaceutical Form: Inhalation solution INN or Proposed INN: tiotropium Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use Product Name: Tiotropium 1.25µg Product Code: Ba 679 Pharmaceutical Form: Inhalation solution INN or Proposed INN: tiotropium Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1.25‐ Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use Product Name: Olodaterol 2.5µg Product Code: BI 1744 Pharmaceutical Form: Inhalation solution INN or Proposed INN: olodaterol Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use CONDITION: Patients with Chronic Obstructive Pulmonary Disease (COPD) ; MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 ‐ Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] SECONDARY OUTCOME: Secondary end point(s): Key secondary endpoints: ; FEV1 AUC0‐12h response [L] ; FEV1 AUC12‐24h response [L] ; ; Secondary endpoints ; Trough FEV1 response [L] ; Peak FEV1 responses [L] ; Trough FVC response [L] ; Peak FVC response [L] ; FVC AUC0‐24h response [L] ; FVC AUC0‐12h response [L] ; FVC AUC12‐24h response [L] ; Timepoint(s) of evaluation of this end point: after 6‐weeks treatment INCLUSION CRITERIA: 1. All patients must sign an informed consent consistent with ICH‐GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post‐bronchodilator FEV1< 80% of predicted normal and a post‐bronchodilator FEV1/FVC <70% at Visit 1. 3. Male or female patients, 40 years of age or older. 4. Patients must be current or ex‐smokers with a smoking history of more than 10 pack years 5. Patients must be able to • perform technically acceptable pulmonary function tests (spirometry), • maintain records (patient paper diary) during the study period, as required in the protocol. • applicable for body plethysmography substudy only: perform technically acceptable body plethysmography measurements. 6. Patients PRIMARY OUTCOME: Main Objective: The primary objective of the trial is to determine the 24‐hour FEV1‐time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment. Primary end point(s): FEV1 AUC0‐24h response [L] Secondary Objective: ‐ to compare the 24‐hour FEV1‐time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg) administered once daily by the RESPIMAT Inhaler with the profile of tiotropium (2.5 µg, 5 µg) and olodaterol (5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment; ; ‐ to determine the 24‐hour profile of other lung function parameters (FVC, FRC, IC, TLC, RV) for tiotropium + olodaterol FDC (2.5/5 µg and 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment and compare with the profiles of tiotropium (2.5 µg, 5 µg) and olodaterol (5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment; ; ‐ to assess the pharmacokinetic profiles of tiotropium and olodaterol after administration of tiotropium + olodaterol (2.5/5 µg) FDC and tiotropium + olodaterol (5/5 µg) FDC in COPD patients; Timepoint(s) of evaluation of this end point: after 6‐weeks treatment