Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness

Inclusion Criteria: * Male and non-pregnant female subjects (40 years of age and older). * Patients with diagnosis of COPD according to the GOLD guidelines. * Post-bronchodilator FEV1 \<80% of the predicted value at the screening visit. * Post-bronchodilator FEV1/FVC ratio ≤0.70 at the screening visit. * Current or former smokers (e.g., with history of = 10 pack-years). * Written informed consent. Exclusion Criteria: * Known respiratory disorder other than COPD including, but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease. * History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known hypersensitivity to any of the proposed ingredients or components of the delivery system. * Hospitalization for COPD or pneumonia within 12 weeks prior to the screening visit. * Treatment for COPD exacerbation within 12 weeks prior to the screening visit. * Viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 6 weeks prior to the screening visit. * Abnormal and significant ECG finding prior to the screening, during the run-in and treatment periods.