Trials / Terminated
TerminatedNCT04636814
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)
A 52-week, Randomized, Double-blind, Double-dummy, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg), 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
- 3,973 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHF6001 1600µg | CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily |
| DRUG | CHF6001 3200µg | CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily |
| DRUG | Placebo | CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily |
| DRUG | Roflumilast | \- 1 tablet of Roflumilast (Daliresp®), 250µg, once daily during the first 4 weeks of treatment then 1 tablet of Roflumilast (Daliresp®), 500µg, once daily for the remaining treatment period and CHF6001 matching placebo, 2 inhalations bid |
Timeline
- Start date
- 2021-07-12
- Primary completion
- 2025-12-23
- Completion
- 2025-12-23
- First posted
- 2020-11-19
- Last updated
- 2026-02-02
Locations
460 sites across 28 countries: United States, Argentina, Austria, Bosnia and Herzegovina, Bulgaria, Chile, Croatia, Czechia, Estonia, Germany, Greece, Hungary, Israel, Latvia, Mexico, Netherlands, New Zealand, North Macedonia, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04636814. Inclusion in this directory is not an endorsement.