Efficacy of DNK333 in Patients With COPD and Cough

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: DNK333 100 mg twice daily; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01287325

DNK333C2201

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

28 participants in 2 patient groups, including a placebo group

DNK333

Experimental group

Treatment:

Drug: DNK333 100 mg twice daily

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo