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

Phase 2

Completed

Interventions: Drug: BCT197
Drug: Prednisone placebo
Drug: BCT197 placebo
Drug: Prednisone

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

Other protocol-defined inclusion/exclusion criteria may apply

Arm && Interventions

Group	Intervention	Description
Treatment D	BCT197	Single oral dose of 20mg dose of BCT197 capsules
Treatment F	BCT197	Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6
Treatment H	BCT197	Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
Treatment A	BCT197	Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
Treatment A	Prednisone placebo	Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
Treatment B/G/E/I	Prednisone placebo	Matching placebo comparator arm
Treatment B/G/E/I	BCT197 placebo	Matching placebo comparator arm
Treatment C	BCT197 placebo	Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules
Treatment C	Prednisone	Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules

Primary Outcome Measures

Name	Time	Method
Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second	Day 5, Day 10	Change in FEV1 from baseline to Day 5 or baseline to Day 10 measured in mL Measure: FEV1 Change in Forced Expiry Volume in 1 second

Secondary Outcome Measures

Name	Time	Method
Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO	Up to Day 29	EXAcerbations of Chronic pulmonary disease tool patient reported outcome (EXACT-PRO) Rolling Average Improvement from Day 1 to Day 29. EXACT-PRO is a 14 point patient reported daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Minimum score is 0 and Maximum score is 14 (higher scores indicate worsening indicative of an exacerbation). Reported value is LS mean improvement from at Day 29 compared to D1 of the study.