Safety & Efficacy of BCT197A2201 in Chronic Obstructive Pulmonary Disease (COPD) Patients Presenting With an Exacerbation
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01332097
First received: April 7, 2011
Last updated: May 17, 2013
Last verified: May 2013
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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
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: | May 17, 2013 |
| 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Prednisone Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013