Efficacy of DNK333 in Patients With COPD and Cough

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Placebo; Drug: DNK333 100 mg twice daily

• Registration Number: NCT01287325
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-04
• Status Verified: 2011-01
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-28
• Last Update Submitted: 2011-01-28
• Study First Posted: 2011-02-01
• Last Update Posted: 2011-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
DNK333	DNK333 100 mg twice daily	-

Primary Outcome Measures

Name	Time	Method
Self-reported cough	At 2 weeks

Secondary Outcome Measures

Name	Time	Method
Sensitivity to capsaicin challenge	At 2 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 London, United Kingdom