Efficacy of DNK333 in Patients With COPD and Cough

Chronic Obstructive Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287325
• Other study ID #: DNK333C2201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 26, 2011
• Last updated: January 28, 2011
• Start date: September 2003

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• DNK333 100 mg twice daily

• Placebo

Locations

Country	Name	City	State
Netherlands	Novartis Investigative Site	Zuidlaren
United Kingdom	Novartis Investigative Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported cough		At 2 weeks	No
Secondary	Sensitivity to capsaicin challenge		At 2 weeks	No