NCT02700919

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Mereo BioPharma · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	BCT197	Capsules will be taken orally with fluids over a 5 day period after randomization
DRUG	Placebo	Capsules will be taken orally with fluids over a 5 day period after randomization

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-11-08
• Completion: 2017-11-28
• First posted: 2016-03-07
• Last updated: 2020-11-30
• Results posted: 2020-11-30

Locations

46 sites across 10 countries: United States, Bulgaria, Czechia, Germany, Hungary, Italy, Latvia, Poland, Romania, Russia