Safety & Efficacy of BCT197A2201 in Chronic Obstructive Pulmonary Disease (COPD) Patients Presenting With an Exacerbation

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01332097

Collaborator

(none)

183

Enrollment

Locations

Arms

Duration (Months)

30.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: BCT197 Drug: Prednisone placebo Drug: BCT197 placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

183 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules	Drug: BCT197 Drug: Prednisone placebo capsules
Placebo Comparator: Treatment B single oral dose of BCT197 placebo capsules + single oral dose of prednisone placebo capsules	Drug: Prednisone placebo capsules Drug: BCT197 placebo capsules
Active Comparator: Treatment C single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules	Drug: Prednisone placebo capsules Drug: BCT197 placebo capsules
Experimental: Treatment D single oral dose of 20mg dose of BCT197 capsules	Drug: BCT197
Placebo Comparator: Treatment E single oral dose of BCT 197 placebo capsules	Drug: BCT197 placebo capsules
Experimental: Treatment F single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6	Drug: BCT197
Placebo Comparator: Treatment G single oral dose of BCT 197 placebo capsules on Day 1 and Day 6	Drug: BCT197 placebo capsules
Experimental: Treatment H single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6	Drug: BCT197
Placebo Comparator: Treatment I single oral dose of BCT 197 placebo capsules on Day 1 and Day 6	Drug: BCT197 placebo capsules

Outcome Measures

Primary Outcome Measures

The improvement in FEV1 over the first 5 days of treatment in Parts I and II, and improvement in FEV1 over the first 10 days in Parts III and IV, relative to placebo. Measure: FEV1 [5 days and 10 days]

Secondary Outcome Measures

Time to recovery using the EXACT-PRO 14 point patient reported outcome Measure: EXACT-PRO [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novartis Investigative Site	Plovdiv	Bulgaria	4000
2	Novartis Investigative Site	Russe	Bulgaria	7002
3	Novartis Investigative Site	Bucuresti	Romania	50159
4	Novartis Investigative Site	Moscow	Russian Federation	107014
5	Novartis Investigative Site	Moscow	Russian Federation	117292
6	Novartis Investigative Site	St. Petersburg	Russian Federation	191015