drugset / Trial / NCT02986321

A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD

NCT02986321

Phase 2 Completed 1130 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the dose-response relationship of different doses of CHF6001 and to identify the optimal dose (s) in terms of benefit/risk ratio for further development in the target patient population.

Timeline

Start
2016-12-15
Primary completion
2017-10-04
Completion
2018-01-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 800 ug
Subject TRANIMILAST Small molecule 400 ug Inhaled
Subject TRANIMILAST Small molecule 800 ug Inhaled
Subject TRANIMILAST Small molecule 1200 ug Inhaled
Subject TRANIMILAST Small molecule 1600 ug Inhaled