NCT04636801|TerminatedPhase 3DMCFDA Drug

Study Stopped

Strategic decision by Sponsor; not due to safety reasons

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)

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

Chiesi Farmaceutici S.p.A.ClinicalTrials.gov

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2 other identifiers

CLI-06001AA1-042020-003666-40

Study Type

interventional

Target

4,710

Locations

29 countries

Sites

441

Timeline

RegisteredNov 2020

StartedJul 2021

CompletionOct 2025

Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

4,710

participants targeted

Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease

Timeline

Completed

Started Jul 2021

Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach

29 countries

441 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

November 16, 2020

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed

8 months until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4.3 years

First QC Date

November 16, 2020

Last Update Submit

December 11, 2025

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDChronic BronchitisPDE4 inhibitoranti-inflammatory respiratory drugTanimilast

Outcome Measures

Primary Outcomes (1)

The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period.
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
Up to 52 weeks

Secondary Outcomes (12)

The time to first moderate or severe exacerbation.
Up to 52 weeks
The annual rate of severe exacerbation.
Up to 52 weeks
The time to first severe exacerbation.
Up to 52 weeks
The number of on-treatment severe exacerbations.
Up to 52 weeks
Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52.
At Week 52
+7 more secondary outcomes

Study Arms (3)

CHF6001 1600µg

EXPERIMENTAL

Drug: Experimental: CHF6001 1600µg

CHF6001 3200µg

EXPERIMENTAL

Drug: Experimental: CHF6001 3200µg

CHF6001 Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PlaceboDRUG

CHF6001 matching placebo, 2 inhalations bid.

CHF6001 Placebo

Experimental: CHF6001 1600µgDRUG

CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).

CHF6001 1600µg

Experimental: CHF6001 3200µgDRUG

CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).

CHF6001 3200µg

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults aged ≥ 40 years with COPD and chronic bronchitis
Current or ex-smokers (history ≥ 10 pack years).
Post-bronchodilator FEV1 \<60% of the subject predicted normal value and FEV1/FVC ratio \< 0.7.
At least, one moderate or severe COPD exacerbation in previous year.
CAT score ≥ 10
Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit

You may not qualify if:

Subjects with current asthma.
Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.
Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
Subjects with COPD emphysema or mixed phenotypes.
Subjects with known respiratory disorders other than COPD.
Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy.
Subjects under Roflumilast treatment within 6 months before study entry.
Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
Subjects with clinically significant cardiovascular.
Subjects with a significant neurological disease.
Subjects with clinically significant laboratory abnormalities.
Subjects with moderate or severe hepatic impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chiesi Farmaceutici S.p.A.lead

Study Sites (447)

Chiesi Clinical Trial - Site 840402

Sheffield, Alabama, 35660-4020, United States

Location

Chiesi Clinical Trial - Site 840480

Northridge, California, 91324-6200, United States

Location

Chiesi Clinical Trial - Site 840487

Cutler Bay, Florida, 33189-1230, United States

Location

Chiesi Clinical Trial - Site 840404

Hollywood, Florida, 33021, United States

Location

Chiesi Clinical Trial - Site 840407

Miami, Florida, 33144-2100, United States

Location

Chiesi Clinical Trial - Site 840444

Miami, Florida, 33144, United States

Location

Chiesi Clinical Trial - Site 840437

Miami, Florida, 33165-2075, United States

Location

Chiesi Clinical Trial - Site 840403

Miami, Florida, 33175-3598, United States

Location

Chiesi Clinical Trial - Site 840463

Orlando, Florida, 32822-5806, United States

Location

Chiesi Clinical Trial - Site 840401

Peachtree Corners, Georgia, 30071-2656, United States

Location

Chiesi Clinical Trial - Site 840478

New Windsor, New York, 12553-7754, United States

Location

Chiesi Clinical Trial - Site 840483

Philadelphia, Pennsylvania, 19140, United States

Location

Chiesi Clinical Trial - Site 840474

Kerrville, Texas, 78028-9640, United States

Location

Chiesi Clinical Trial - Site 840409

Plano, Texas, 75025, United States

Location

Chiesi Clinical Trial - Site 840481

San Antonio, Texas, 78229, United States

Location

Chiesi Clinical Trial - Site 8455

Durrës, Albania

Location

Chiesi Clinical Trial - Site 8459

Durrës, Albania

Location

Chiesi Clinical Trial - Site 8457

Elbasan, Albania

Location

Chiesi Clinical Trial - Site 8460

Korçë, Albania

Location

Chiesi Clinical Trial - Site 8451

Tirana, Albania

Location

Chiesi Clinical Trial - Site 8452

Tirana, Albania

Location

Chiesi Clinical Trial - Site 8453

Tirana, Albania

Location

Chiesi Clinical Trial - Site 8454

Tirana, Albania

Location

Chiesi Clinical Trial - Site 8456

Tirana, Albania

Location

Chiesi Clinical Trial - Site 8458

Tirana, Albania

Location

Chiesi Clinical Trial - Site 32415

Buenos Aires, 7540, Argentina

Location

Chiesi Clinical Trial - Site 32407

Buenos Aires, Argentina

Location

Chiesi Clinical Trial - Site 32410

Buenos Aires, Argentina

Location

Chiesi Clinical Trial - Site 32454

Buenos Aires, Argentina

Location

Chiesi Clinical Trial - Site 32457

Caba, Argentina

Location

Chiesi Clinical Trial - Site 32459

CABA, Argentina

Location

Chiesi Clinical Trial - Site 32414

Ciudad Autonoma de Buenos Aire, Argentina

Location

Chiesi Clinical Trial - Site 32403

Córdoba, Argentina

Location

Chiesi Clinical Trial - Site 32409

Córdoba, Argentina

Location

Chiesi Clinical Trial - Site 32401

Florida, Argentina

Location

Centro de Medicina Respiratoria - Concepcion del Uruguay - site 32463

Forestal Entre Ríos, 89862-000, Argentina

Location

Chiesi Clinical Trial - Site 32455

La Plata, Argentina

Location

Chiesi Clinical Trial - Site 32458

Mar del Plata, Argentina

Location

Chiesi Clinical Trial - Site 32462

Mar del Plata, Argentina

Location

Chiesi Clinical Trial - Site 32405

Mendoza, Argentina

Location

Chiesi Clinical Trial - Site 32411

Mendoza, Argentina

Location

Chiesi Clinical Trial - Site 32413

Mendoza, Argentina

Location

Chiesi Clinical Trial - Site 32402

Monte Grande, Argentina

Location

Chiesi Clinical Trial - Site 32406

Quilmes, Argentina

Location

Chiesi Clinical Trial - Site 32453

Rosario, Argentina

Location

Chiesi Clinical Trial - Site 32460

San Fernando, Argentina

Location

Chiesi Clinical Trial - Site 32408

San Juan Bautista, Argentina

Location

Chiesi Clinical Trial - Site 32412