A multi-center, randomized, double-blind, parallel group, placebo controlled study, including an additional open label tiotropium group, to assess the efficacy, safety and tolerability of different doses of orally inhaled AD 237 administered once daily for 28 days in subjects with chronic obstructive pulmonary disease (COPD)

INTERVENTION: Product Name: AD 237 30 microgram Product Code: AD 237 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Glycopyrronium bromide CAS Number: 596‐51‐0 Current Sponsor code: AD 237 Other descriptive name: glycopyrrolate Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30‐ Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use Product Name: AD 237 60 microgram Product Code: AD 237 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Glycopyrronium bromide CAS Number: 596‐51‐0 Current Sponsor code: AD 237 Other descriptive name: glycopyrrolate Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60‐ Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use Product Name: AD 237 120 microgram Product Code: AD 237 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Glycopyrronium bromide CAS Number: 596‐51‐0 Current Sponsor code: AD 237 Other descriptive name: glycopyrrolate Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 120‐ Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use Product Name: AD 237 240microgram Product Code: AD 237 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Glycopyrronium bromide CAS Number: 596‐51‐0 Current Sponsor code: AD 237 Other descriptive name: glycopyrrolate Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 240‐ Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use Trade Name: Spiriva Product Name: tiotropium Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: tiotropium Concentration unit: µg microgram(s) Concentration type CONDITION: Chronic obstructive pulmonary disease (COPD) PRIMARY OUTCOME: Main Objective: Primary objective: to investigate the dose‐response and efficacy of four different doses of AD 237 administered by oral inhalation once daily for 28 days in subjects with COPD compared with placebo.; Primary end point(s): Trough FEV1 at Day 28 compared to Baseline Secondary Objective: Secondary objectives: to assess the safety and tolerability of AD 237 over a range of doses; to determine plasma AD 237 levels following oral inhalation of four different AD 237 doses in subjects with COPD; and to profile the pharmacological effect of different AD 237 doses compared to the long‐acting anticholinergic, tiotropium.; INCLUSION CRITERIA: (a) Male or female subjects, aged 40 years and over. (b) Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea. Prior diagnoses of chronic bronchitis and/or emphysema will be accepted diagnoses of COPD. (c) Post‐bronchodilator FEV1 less than or equal to 65% and greater than or equal to 30% of the predicted normal value. (d) Pre‐bronchodilator FEV1/FVC ratio of < 70%. (e) Current or ex‐smokers with a smoking history of at least 10 pack years. (f) Able to understand the nature of the study, comply with the protocol and give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range