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Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease

The purpose of this study is to compare the efficacy and safety of BCT197 when added on to standard of care in adult subjects with acute respiratory exacerbations of chronic obstructive pulmonary disease requiring hospitalization. Additionally, the study will characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the study will be 26 weeks. Subjects will receive study treatment administration over a period of 5 days after randomization. It is expected that approximately 255 subjects will complete the study and follow-up.

Clinical Trial Information

Protocol
IRB#: 24074, WIRB#: 20161172
Phase
2
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Investigator
Gerard J Criner, MD
Coordinator
Carla Grabianowski, RN

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Contact
For more information about this trial or to inquire about eligibility, email breathe@temple.edu

Full Title

A Phase II, Two-Part, Randomised, Multi-Centre, Multinational, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Efficacy and Safety of BCT197 When Added on to Standard of Care for the Treatment of Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease Requiring Hospitalisation in Adults