NCT01332097

Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation

An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Mereo BioPharma · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess preliminary parameters of safety and efficacy of a single dose of BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

Detailed description

This was an exploratory, double-blind, randomized, placebo-controlled, multicenter, adaptive parallel-group design study in four parts in patients with acute COPD exacerbation. In Part I, patients were randomized to receive either a single dose of 75mg BCT197, placebo or 40 mg oral prednisone in the ratio of 1:1:1. In Part II patients were randomized to receive either a single dose of 20 mg BCT197 or placebo in the ratio of 5:1. Patients in Parts I and II received their single dose on Day 1 of the study. In Parts III and IV patients were randomized to receive either BCT197 or placebo in a ratio of 5:1 at a dose of 20mg (Part III) or 75 mg (Part IV) with patients receiving a single dose on both Day 1 and Day 6 of the study.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	BCT197
DRUG	Prednisone placebo	capsules
DRUG	BCT197 placebo	capsules
DRUG	Prednisone	capsules

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-04-08
• Last updated: 2023-03-21
• Results posted: 2023-03-21

Locations

6 sites across 3 countries: Bulgaria, Romania, Russia

Regulatory

• FDA-regulated drug study