drugset / Trial / NCT01730404
Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients
RandomizedCrossoverQuadruple-blindTreatment
Summary
Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics (effect on biological markers of inflammation in induced sputum and in blood, and on pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of daily inhaled dosing.
Timeline
- Start
- 2012-10
- Primary completion
- 2013-10
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Roflumilast | Small molecule | — | — |
| Subject | TRANIMILAST | Small molecule | 1200 ug | Inhaled |