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
  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:


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 April 16, 2014