drugset / Trial / NCT01730404

Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients

NCT01730404

Phase 2 Completed 55 enrolled Chiesi Farmaceutici S.p.A.
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

EvaluationDrugModalityDoseRoute
Comparator Roflumilast Small molecule
Subject TRANIMILAST Small molecule 1200 ug Inhaled