Overview
Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
Status:
Completed
Completed
Trial end date:
2018-04-30
2018-04-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Lupin, Inc.Treatments:
Bromides
Tiotropium Bromide
Criteria
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.