Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease Exacerbation Pulmonary Inflammation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 183
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules arm 2: Matching placebo comparator arm arm 3: Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules arm 4: Single oral dose of 20mg dose of BCT197 capsules arm 5: Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6 arm 6: Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6

Interventions: intervention 1: BCT197 intervention 2: Prednisone placebo intervention 3: BCT197 placebo intervention 4: Prednisone
Intervention descriptions: intervention 1: None intervention 2: capsules intervention 3: capsules intervention 4: capsules

Protocol document: