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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: BCT197
* Drug: Prednisone placebo
* Drug: BCT197 placebo
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules | Drug: BCT197<br> <br> Drug: Prednisone placebo<br>* capsules<br>|
| Placebo Comparator: Treatment B/G/E/I<br>Matching placebo comparator arm | Drug: Prednisone placebo<br>* capsules<br>Drug: BCT197 placebo<br>* capsules<br>|
| Active Comparator: Treatment C<br>Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules | Drug: BCT197 placebo<br>* capsules<br>Drug: Prednisone<br>* capsules<br>|
| Experimental: Treatment D<br>Single oral dose of 20mg dose of BCT197 capsules | Drug: BCT197<br> <br> |
| Experimental: Treatment F<br>Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6 | Drug: BCT197<br> <br> |
| Experimental: Treatment H<br>Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6 | Drug: BCT197<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second | 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 | Day 5, Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO | 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. | Up to Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Exacerbation, Pulmonary Inflammation