Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration

Inclusion Criteria: * Males and females patients aged 40-75 years; * Written informed consent obtained; * Diagnosis of moderate-severe COPD, according to the GOLD guidelines; * Current or ex-smokers with a smoking history of ≥ 10 pack-years * Post bronchodilator FEV1 between 40% and 80% predicted values (40% ≤ FEV1 \< 80%), documented at screening visit ; * Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) ≤ 0.70 (absolute value) documented at screening visit; * Airway reversibility of at least 100 mL within 30 to 45 minutes after inhalation of ipratropium 80µg. Exclusion Criteria: * History of chronic or seasonal allergy * Blood eosinophil count above 600 per µl * Clinically relevant findings on physical examination laboratory and ECG parameters at screening * Occurrence of clinically relevant abnormalities in the 24-h Holter ECG recording at screening; * Significant disease not related to COPD (eg. Myocardial infarction, stroke within the preceding 6 months); * Respiratory tract infection (including upper tract) 4 weeks prior to study entry requiring changing treatment; * Patients requiring oxygen therapy on a daily basis for chronic hypoxemia; * History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which is considered to be clinically significant by the investigator. * Intolerance/hypersensitivity or any contra-indication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study. * History of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance. * Patients treated with slow-release oral or parental corticosteroids 8 weeks prior to Screening Visit. * Patients treated with tiotropium in the 10 days prior to the Screening Visit; * Pregnant or lactating women and female or male subjects not willing to use an acceptable method of contraception.