Efficacy of DNK333 in Patients With COPD and Cough

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.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01287325

Enrollment

Registered

2011-02-01

Start date

2003-09-30

Completion date

Unknown

Last updated

2011-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease, Cough, DNK333

Brief summary

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

Interventions

DRUGDNK333 100 mg twice daily

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Self-reported cough	At 2 weeks

Secondary

Measure	Time frame
Sensitivity to capsaicin challenge	At 2 weeks

Countries

Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026