Trial · 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)
NCT04636801, Phase 3, Terminated, Chiesi Farmaceutici S.p.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT04636801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04636801
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT04636801
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4,710 participants, actual
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Experimental: CHF6001 1600µg, Experimental: CHF6001 3200µg, Placebo
- First posted
- 2020-11-19
- Last updated
- 2025-12-17
- Other registries' IDs
- eudract:2020-003666-40
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period. | Up to 52 weeks | 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 |
| Secondary | The time to first moderate or severe exacerbation. | Up to 52 weeks | |
| Secondary | The annual rate of severe exacerbation. | Up to 52 weeks | |
| Secondary | The time to first severe exacerbation. | Up to 52 weeks | |
| Secondary | The number of on-treatment severe exacerbations. | Up to 52 weeks | |
| Secondary | Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52. | At Week 52 | |
| Secondary | Change from baseline in SGRQ total and domain scores at week 52. | At week 52 | |
| Secondary | SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52. | At week 52 | |
| Secondary | Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores | Up to 52 weeks | |
| Secondary | E-RS response (change from baseline E-RS Total score ≤ -2) at week 52. | At week 52 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04636801
GET https://conductscience.org/api/trials/v1/NCT04636801/registered