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Efficacy of DNK333 in Patients With COPD and Cough

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01287325
First received: January 26, 2011
Last updated: January 28, 2011
Last verified: January 2011
History of Changes
  Purpose

This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients with COPD and cough.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: DNK333 100 mg twice daily
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Self-reported cough [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity to capsaicin challenge [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: September 2003
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DNK333 Drug: DNK333 100 mg twice daily
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287325

Locations
Netherlands
Novartis Investigative Site
Zuidlaren, Netherlands
United Kingdom
Novartis Investigative Site
London, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01287325     History of Changes
Other Study ID Numbers: DNK333C2201
Study First Received: January 26, 2011
Last Updated: January 28, 2011
Health Authority: Netherlands: Medicines Evaluation Board (MEB)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Chronic obstructive pulmonary disease
Cough
DNK333

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013