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A 52-week, Placebo-controlled...

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)

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4710 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CHF6001 1600µg

Group Type EXPERIMENTAL

Experimental: CHF6001 1600µg

Intervention Type DRUG

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

CHF6001 3200µg

Group Type EXPERIMENTAL

Experimental: CHF6001 3200µg

Intervention Type DRUG

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

CHF6001 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

CHF6001 matching placebo, 2 inhalations bid.

Interventions

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Experimental: CHF6001 1600µg

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

Intervention Type DRUG

Experimental: CHF6001 3200µg

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

Intervention Type DRUG

Placebo

CHF6001 matching placebo, 2 inhalations bid.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus F. Rabe, Prof.

Role: PRINCIPAL_INVESTIGATOR

LungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY

Locations

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Chiesi Clinical Trial - Site 840402

Sheffield, Alabama, United States

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Chiesi Clinical Trial - Site 840480

Northridge, California, United States

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Chiesi Clinical Trial - Site 840487

Cutler Bay, Florida, United States

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Chiesi Clinical Trial - Site 840404

Hollywood, Florida, United States

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Chiesi Clinical Trial - Site 840407

Miami, Florida, United States

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Chiesi Clinical Trial - Site 840444

Miami, Florida, United States

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Chiesi Clinical Trial - Site 840437

Miami, Florida, United States

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Chiesi Clinical Trial - Site 840403

Miami, Florida, United States

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Chiesi Clinical Trial - Site 840463

Orlando, Florida, United States

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Chiesi Clinical Trial - Site 840401

Peachtree Corners, Georgia, United States

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Chiesi Clinical Trial - Site 840478

New Windsor, New York, United States

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Chiesi Clinical Trial - Site 840483

Philadelphia, Pennsylvania, United States

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Chiesi Clinical Trial - Site 840474

Kerrville, Texas, United States

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Chiesi Clinical Trial - Site 840409

Plano, Texas, United States

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Chiesi Clinical Trial - Site 840481

San Antonio, Texas, United States

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Chiesi Clinical Trial - Site 8455

Durrës, , Albania

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Chiesi Clinical Trial - Site 8459

Durrës, , Albania

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Chiesi Clinical Trial - Site 8457

Elbasan, , Albania

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Chiesi Clinical Trial - Site 8460

Korçë, , Albania

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Chiesi Clinical Trial - Site 8451

Tirana, , Albania

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Chiesi Clinical Trial - Site 8452

Tirana, , Albania

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Chiesi Clinical Trial - Site 8453

Tirana, , Albania

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Chiesi Clinical Trial - Site 8454

Tirana, , Albania

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Chiesi Clinical Trial - Site 8456

Tirana, , Albania

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Chiesi Clinical Trial - Site 8458

Tirana, , Albania

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Chiesi Clinical Trial - Site 32415

Buenos Aires, , Argentina

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Chiesi Clinical Trial - Site 32407

Buenos Aires, , Argentina

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Chiesi Clinical Trial - Site 32410

Buenos Aires, , Argentina

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Chiesi Clinical Trial - Site 32454

Buenos Aires, , Argentina

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Chiesi Clinical Trial - Site 32457

Caba, , Argentina

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Chiesi Clinical Trial - Site 32459

CABA, , Argentina

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Chiesi Clinical Trial - Site 32414

Ciudad Autonoma de Buenos Aire, , Argentina

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Chiesi Clinical Trial - Site 32403

Córdoba, , Argentina

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Chiesi Clinical Trial - Site 32409

Córdoba, , Argentina

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Chiesi Clinical Trial - Site 32401

Florida, , Argentina

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Centro de Medicina Respiratoria - Concepcion del Uruguay - site 32463

Forestal Entre Ríos, , Argentina

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Chiesi Clinical Trial - Site 32455

La Plata, , Argentina

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Chiesi Clinical Trial - Site 32458

Mar del Plata, , Argentina

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Chiesi Clinical Trial - Site 32462

Mar del Plata, , Argentina

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Chiesi Clinical Trial - Site 32405

Mendoza, , Argentina

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Chiesi Clinical Trial - Site 32411

Mendoza, , Argentina

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Chiesi Clinical Trial - Site 32413

Mendoza, , Argentina

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Chiesi Clinical Trial - Site 32402

Monte Grande, , Argentina

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Chiesi Clinical Trial - Site 32406

Quilmes, , Argentina

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Chiesi Clinical Trial - Site 32453

Rosario, , Argentina

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Chiesi Clinical Trial - Site 32460

San Fernando, , Argentina

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