Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study

INTERVENTION: Product Name: BI 1744 solution for the use in Respimat Inhaler Product Code: BI 1744 CL Pharmaceutical Form: Inhalation vapour, solution Current Sponsor code: BI 1744 CL Concentration type: equal Concentration number: 1 µg/actuation‐ Route of administration of the placebo: Inhalation use Product Name: BI 1744 CL solution for the use in Respimat Inhaler Product Code: BI 1744 CL Pharmaceutical Form: Inhalation vapour, solution Current Sponsor code: BI 1744 CL Concentration type: equal Concentration number: 2,5 µg/actuation‐ Route of administration of the placebo: Inhalation use Product Name: BI 1744 CL solution for the use in Respimat Inhaler Product Code: BI 1744 CL Pharmaceutical Form: Inhalation vapour, solution Current Sponsor code: BI 1744 CL Concentration type: equal Concentration number: 5 µg/actuation‐ Route of administration of the placebo: Inhalation use Product Name: BI 1744 CL solution for the use in Respimat Inhaler Product Code: BI 1744 CL Pharmaceutical Form: Inhalation vapour, solution Current Sponsor code: BI 1744 CL Concentration type: equal Concentration number: 10 µg/actuation‐ Route of administration of the placebo: Inhalation use CONDITION: Chronic Obstructive Pulmonary Disease (COPD) ; MedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD PRIMARY OUTCOME: Main Objective: The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations. Primary end point(s): The primary efficacy variable will be forced expiratory volume in one second (FEV1). The primary endpoint is the trough FEV1 response [L] after four weeks of treatment.; ; Trough FEV1 is defined as the mean of the two FEV1 values (performed at ‐1 hour and ‐10 minutes prior to test‐drug inhalation) at the end of the dosing interval, 24 hours post‐drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre treatment FEV1 values measured at Visit 2 (‐ 1 hour and ‐ 10 minutes) prior to administration of the first dose of study medication. Secondary Objective: INCLUSION CRITERIA: 1. All patients must have a diagnosis of chronic obstructive pulmonary disease (P06‐12085) and must meet the following spirometric criteria: Patients must have relatively stable, moderate to severe airway obstruction with a post‐bronchodilator FEV1 > 30% of predicted normal and < 80% of predicted normal [ECSC, R94‐1408] and a post‐bronchodilator FEV1 / FVC < 70% at Visit 1 [See Section 5.1 for ECSC predicted normal equations] 2. Male or female patients, 40 years of age or older 3. Patients must be current or ex‐smokers with a smoking history of more than 10 pack years Pack Years = (Number of cigarettes/day)/20 x years of smoking Patients who have never smoked cigarettes must be excluded 4. Patients must be able to perform technically acceptable pulmonary function tests (both supervised and unsupervised) and PEFR measurements, and must be able to maintain records (Patient Daily e‐Diary) during the study period as required in the protoc