Back to resultsEfficacy of DNK333 in Patients With COPD and Cough
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DNK333 100 mg twice daily
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Cough, DNK333
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate COPD
- Forced expiratory volume in 1 second (FEV1) ≥30% predicted
- FEV1/FVC (forced vital capacity) <70%
- Significant amount of cough and minimal amount of sputum production, both as judged by self reporting
Exclusion criteria:
- Upper or lower airway infection within 4 weeks prior to screening
- COPD exacerbation within 4 weeks prior to screening
- Past history or current diagnosis of congestive heart failure, cirrhosis or hepatic failure
- History of lung cancer or pulmonary resection/thoracic radiotherapy
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DNK333
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Self-reported cough
Secondary Outcome Measures
Sensitivity to capsaicin challenge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01287325
Brief Title
Efficacy of DNK333 in Patients With COPD and Cough
Official Title
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Clinical Efficacy, Tolerability and Safety of Two Weeks Treatment With DNK333 100 mg Bid in Patients With COPD and Cough.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients with COPD and cough.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease, Cough, DNK333
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DNK333
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DNK333 100 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Self-reported cough
Time Frame
At 2 weeks
Secondary Outcome Measure Information:
Title
Sensitivity to capsaicin challenge
Time Frame
At 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate COPD
Forced expiratory volume in 1 second (FEV1) ≥30% predicted
FEV1/FVC (forced vital capacity) <70%
Significant amount of cough and minimal amount of sputum production, both as judged by self reporting
Exclusion criteria:
Upper or lower airway infection within 4 weeks prior to screening
COPD exacerbation within 4 weeks prior to screening
Past history or current diagnosis of congestive heart failure, cirrhosis or hepatic failure
History of lung cancer or pulmonary resection/thoracic radiotherapy
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Zuidlaren
Country
Netherlands
Facility Name
Novartis Investigative Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy of DNK333 in Patients With COPD and Cough
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