A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

Phase 3 Terminated 4710 enrolled Chiesi Farmaceutici S.p.A.

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2021-07-14
Primary completion: 2025-10-31
Completion: 2025-10-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TRANIMILAST	Small molecule	400 ug	Inhaled
Subject	TRANIMILAST	Small molecule	800 ug	Inhaled

A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

Summary

Timeline

Drugs

Indications