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)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT04636814

Run by

Chiesi Farmaceutici S.p.A.

People needed

3973

Starts

2021-07-12

Expected to finish

2025-12-23

Last updated by the study team

2026-02-02

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Chiesi Clinical Trial - Site 840614 — Foley, Alabama, United States
• Chiesi Clinical Trial - Site 840670 — Guntersville, Alabama, United States
• Chiesi Clinical Trial - Site 840720 — Mobile, Alabama, United States
• Chiesi Clinical Trial - Site 840643 — Saraland, Alabama, United States
• Chiesi Clinical Trial - Site 840638 — Phoenix, Arizona, United States
• Chiesi Clinical Trial - Site 840684 — Conway, Arkansas, United States
• Chiesi Clinical Trial - Site 840675 — Laguna Hills, California, United States
• Chiesi Clinical Trial - Site 840666 — Los Angeles, California, United States
• Chiesi Clinical Trial - Site 840511 — Newport Beach, California, United States
• Chiesi Clinical Trial - Site 840680 — Northridge, California, United States
• Chiesi Clinical Trial - Site 840605 — Northridge, California, United States
• Chiesi Clinical Trial - Site 840700 — Pomona, California, United States
• Chiesi Clinical Trial - Site 840531 — Westminster, California, United States
• Chiesi Clinical Trial - Site 840636 — Centennial, Colorado, United States
• Chiesi Clinical Trial - Site 840688 — Lakewood, Colorado, United States
• Chiesi Clinical Trial - Site 840735 — Brooksville, Florida, United States
• Chiesi Clinical Trial - Site 840513 — Chiefland, Florida, United States
• Chiesi Clinical Trial - Site 840652 — Clearwater, Florida, United States
• Chiesi Clinical Trial - Site 840569 — Clearwater, Florida, United States
• Chiesi Clinical Trial - Site 840545 — Coral Gables, Florida, United States
• Chiesi Clinical Trial - Site 840603 — Cutler Bay, Florida, United States
• Chiesi Clinical Trial - Site 840587 — Cutler Bay, Florida, United States
• Chiesi Clinical Trial - Site 840568 — Cutler Bay, Florida, United States
• Chiesi Clinical Trial - Site840539 — Daytona Beach, Florida, United States
• Chiesi Clinical Trial - Site 840635 — Andalusia, Alabama, United States

Full record on ClinicalTrials.gov

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