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A 52-week, Placebo- and Activ...

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)

Last Updated: 2026-01-13

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

3973 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2025-12-16

Brief Summary

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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.

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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

CHF6001 1600µg

Intervention Type DRUG

CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily

CHF6001 3200µg

Group Type EXPERIMENTAL

CHF6001 3200µg

Intervention Type DRUG

CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily

Roflumilast

Group Type ACTIVE_COMPARATOR

Roflumilast

Intervention Type DRUG

\- 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

Interventions

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CHF6001 1600µg

CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily

Intervention Type DRUG

CHF6001 3200µg

CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily

Intervention Type DRUG

Placebo

CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily

Intervention Type DRUG

Roflumilast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults aged ≥ 40 years, with COPD and with chronic bronchitis.
* Current smokers or ex-smokers (history of ≥10 pack years).
* Post-bronchodilator FEV1 \<50% of the patient predicted normal value and FEV1/FVC ratio \< 0.7.
* At least, one moderate or severe COPD exacerbation in the 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 before study entry and randomisation
* Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
* Subjects with primary diagnosis of emphysema not related to COPD.
* Subjects with known respiratory disorders other than COPD.
* Subjects with lung volume reduction surgery.
* Subjects with active cancer or a history of lung cancer.
* 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 condition.
* Subjects with 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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Fernando J. MARTINEZ, Prof.

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA

Locations

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Chiesi Clinical Trial - Site 840635

Andalusia, Alabama, United States

Site Status

Chiesi Clinical Trial - Site 840614

Foley, Alabama, United States

Site Status

Chiesi Clinical Trial - Site 840670

Guntersville, Alabama, United States

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Chiesi Clinical Trial - Site 840720

Mobile, Alabama, United States

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Chiesi Clinical Trial - Site 840643

Saraland, Alabama, United States

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Chiesi Clinical Trial - Site 840638

Phoenix, Arizona, United States

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Chiesi Clinical Trial - Site 840684

Conway, Arkansas, United States

Site Status

Chiesi Clinical Trial - Site 840675

Laguna Hills, California, United States

Site Status

Chiesi Clinical Trial - Site 840666

Los Angeles, California, United States

Site Status

Chiesi Clinical Trial - Site 840511

Newport Beach, California, United States

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Chiesi Clinical Trial - Site 840680

Northridge, California, United States

Site Status

Chiesi Clinical Trial - Site 840605

Northridge, California, United States

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Chiesi Clinical Trial - Site 840700

Pomona, California, United States

Site Status

Chiesi Clinical Trial - Site 840531

Westminster, California, United States

Site Status

Chiesi Clinical Trial - Site 840636

Centennial, Colorado, United States

Site Status

Chiesi Clinical Trial - Site 840688

Lakewood, Colorado, United States

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Chiesi Clinical Trial - Site 840735

Brooksville, Florida, United States

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Chiesi Clinical Trial - Site 840513

Chiefland, Florida, United States

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Chiesi Clinical Trial - Site 840652

Clearwater, Florida, United States

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Chiesi Clinical Trial - Site 840569

Clearwater, Florida, United States

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Chiesi Clinical Trial - Site 840545

Coral Gables, Florida, United States

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Chiesi Clinical Trial - Site 840603

Cutler Bay, Florida, United States

Site Status

Chiesi Clinical Trial - Site 840587

Cutler Bay, Florida, United States

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Chiesi Clinical Trial - Site 840568

Cutler Bay, Florida, United States

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Chiesi Clinical Trial - Site840539

Daytona Beach, Florida, United States

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Chiesi Clinical Trial - Site 840554

DeBary, Florida, United States

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Chiesi Clinical Trial - Site 840625

Doral, Florida, United States

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