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

Overview

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.

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

Interventions

Eligibility

Locations (6)

Outcomes