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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01332097
First received: April 7, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: BCT197
Drug: Prednisone placebo
Drug: BCT197 placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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 [ Time Frame: 5 days and 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recovery using the EXACT-PRO 14 point patient reported outcome Measure: EXACT-PRO [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: March 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332097

Locations
Bulgaria
Novartis Investigative Site
Plovdiv, Bulgaria, 4000
Novartis Investigative Site
Russe, Bulgaria, 7002
Romania
Novartis Investigative Site
Bucuresti, Romania, 50159
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 117292
Novartis Investigative Site
Moscow, Russian Federation, 107014
Novartis Investigative Site
St. Petersburg, Russian Federation, 191015
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01332097     History of Changes
Other Study ID Numbers: CBCT197A2201, 2010-021723-27
Study First Received: April 7, 2011
Last Updated: February 19, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency

Keywords provided by Novartis:
Chronic Obstructive Pulmonary Disease
Exacerbation
Pulmonary Inflammation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Prednisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014