A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

Phase 3 Terminated 3973 enrolled Chiesi Farmaceutici S.p.A.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.

Timeline

Start: 2021-07-12
Primary completion: 2025-12-23
Completion: 2025-12-23

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Roflumilast	Small molecule	500 ug	Oral
Subject	TRANIMILAST	Small molecule	1600 ug	Inhaled
Subject	TRANIMILAST	Small molecule	3200 ug	Inhaled

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

Summary

Timeline

Drugs

Indications