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.