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Efficacy of DNK333 in Patients With COPD and Cough

This study has been completed.
Information provided by:
Novartis Identifier:
First received: January 26, 2011
Last updated: January 28, 2011
Last verified: January 2011
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: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Sensitivity to capsaicin challenge [ Time Frame: At 2 weeks ]

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


Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01287325

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

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT01287325     History of Changes
Other Study ID Numbers: DNK333C2201
Study First Received: January 26, 2011
Last Updated: January 28, 2011

Keywords provided by Novartis:
Chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on August 17, 2017