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

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover, Multicenter Clinical Study to Assess the Efficacy and Safety of Once Daily Administration of Lupin Tiotropium Bromide Inhalation Powder Compared to SPIRIVA® HANDIHALER® and Placebo in Patients With COPD Including a 12-Week Open Label Extension to Assess Inhaler Robustness

The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).

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.