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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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).

Key facts

Study ID

NCT03137992

Run by

Lupin, Inc.

People needed

377

Starts

2017-11-21

Expected to finish

2018-04-30

Last updated by the study team

2021-04-05

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Research Center Site #1017 — Andalusia, Alabama, United States
• Investigational Research Center Site #1003 — Jasper, Alabama, United States
• Investigational Research Center Site #1008 — Glendale, Arizona, United States
• Investigational Research Center Site #1034 — Los Angeles, California, United States
• Investigational Research Center Site #1028 — Riverside, California, United States
• Investigational Research Center Site #1010 — Westminster, California, United States
• Investigational Research Center Site #1016 — Colorado Springs, Colorado, United States
• Investigational Research Center Site #1026 — Clearwater, Florida, United States
• Investigational Research Center Site #1019 — Clearwater, Florida, United States
• Investigational Research Center Site #1035 — Clearwater, Florida, United States
• Investigational Research Center Site #1036 — Orlando, Florida, United States
• Investigational Research Center Site #1001 — North Dartmouth, Massachusetts, United States
• Investigational Research Center Site #1011 — Fridley, Minnesota, United States
• Investigational Research Center Site #1029 — St Louis, Missouri, United States
• Investigational Research Center Site #1007 — Las Vegas, Nevada, United States
• Investigational Research Center Site #1032 — Raleigh, North Carolina, United States
• Investigational Research Center Site #1037 — Columbus, Ohio, United States
• Investigational Research Center Site #1018 — Edmond, Oklahoma, United States
• Investigational Research Center Site #1009 — Oklahoma City, Oklahoma, United States
• Investigational Research Center Site #1033 — Tulsa, Oklahoma, United States
• Investigational Research Center Site #1005 — Medford, Oregon, United States
• Investigational Research Center Site #1006 — Portland, Oregon, United States
• Investigational Research Center Site #1015 — Easley, South Carolina, United States
• Investigational Research Center Site #1012 — Gaffney, South Carolina, United States
• Investigational Research Center Site #1023 — Rock Hill, South Carolina, United States

Full record on ClinicalTrials.gov

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