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NCT04636801 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Chiesi Farmaceutici S.p.A..
- Terminated
- Registry status
- Phase 3
- Development phase
- 4,710
- Enrollment target
NCT04636801: Clinical Trial Phase 3 study, sponsored by Chiesi Farmaceutici S.p.A..
NCT04636801 is a Phase 3 study that was terminated before completion, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 4,710 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (510% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04636801, a Phase 3 study, was terminated before completion, sponsored by Chiesi Farmaceutici S.p.A..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4,710 participants
- Enrollment target
Study 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.
Primary Outcome
Moderate or severe exacerbation is defined by symptomatic worsening of COPD: * Moderate: requiring use of systemic corticosteroid (oral/IV/IM corticosteroids), and/or use of antibiotics * Severe: requiring hospitalisation or resulting in death
Interventions
- DRUG Placebo
- DRUG Experimental: CHF6001 1600µg
- DRUG Experimental: CHF6001 3200µg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,710 participants |
| Start Date | 2021-07-14 |
| Est. Completion | 2025-10-31 |
| Phase | Phase 3 |
Why NCT04636801 stopped before completion
NCT04636801 is an interventional study that assigns participants to a tested intervention. Its 4,710 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (510% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04636801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04636801 about?
NCT04636801 is a clinical study titled "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)". 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.
What is the current status of trial NCT04636801?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4,710 participants. The study started on 2021-07-14. Estimated completion is 2025-10-31.
What interventions are being tested in trial NCT04636801?
The interventions under investigation include: Placebo (DRUG), Experimental: CHF6001 1600µg (DRUG), Experimental: CHF6001 3200µg (DRUG).
Who is sponsoring clinical trial NCT04636801?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04636801's enrollment target sits among peer trials
4,710 54th of 2000 higher than 1,947 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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