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
Overview
- Phase
- Phase 2
- Intervention
- BCT197 placebo
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Mereo BioPharma
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with COPD (Stage II to IV) with a COPD exacerbation.
- •Smoking history of 10 pack years.
- •Females must not be of child-bearing potential.
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
Arms & Interventions
Treatment C
Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules
Intervention: BCT197 placebo
Treatment C
Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules
Intervention: Prednisone
Treatment D
Single oral dose of 20mg dose of BCT197 capsules
Intervention: BCT197
Treatment F
Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6
Intervention: BCT197
Treatment H
Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
Intervention: BCT197
Treatment B/G/E/I
Matching placebo comparator arm
Intervention: Prednisone placebo
Treatment B/G/E/I
Matching placebo comparator arm
Intervention: BCT197 placebo
Treatment A
Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
Intervention: BCT197
Treatment A
Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
Intervention: Prednisone placebo
Outcomes
Primary Outcomes
Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second
Time Frame: 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 Outcomes
- 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)