NCT04636801

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)

A 52-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,710 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Experimental: CHF6001 1600µg	CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).
DRUG	Experimental: CHF6001 3200µg	CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).
DRUG	Placebo	CHF6001 matching placebo, 2 inhalations bid.

Timeline

• Start date: 2021-07-14
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2020-11-19
• Last updated: 2025-12-17

Locations

447 sites across 30 countries: United States, Albania, Argentina, Australia, Austria, Bosnia and Herzegovina, Bulgaria, Chile, China, Czechia, Georgia, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, North Macedonia, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study