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OpenTrials
Completed

NCT Number: NCT01287325

Efficacy of DNK333 in Patients With COPD and Cough

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Cough Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative Site, Zuidlaren, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNK333 100 mg twice daily

Drug

Placebo

Drug

Primary outcomes

  1. Self-reported cough

    Time frame: At 2 weeks

Secondary outcomes

  1. Sensitivity to capsaicin challenge

    Time frame: At 2 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2004
First posted
Feb 1, 2011
Registry last updated
Feb 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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