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)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT04636801

Run by

Chiesi Farmaceutici S.p.A.

People needed

4710

Starts

2021-07-14

Expected to finish

2025-10-31

Last updated by the study team

2025-12-17

Who can join

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

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

Where it is running

• Chiesi Clinical Trial - Site 840480 — Northridge, California, United States
• Chiesi Clinical Trial - Site 840487 — Cutler Bay, Florida, United States
• Chiesi Clinical Trial - Site 840404 — Hollywood, Florida, United States
• Chiesi Clinical Trial - Site 840407 — Miami, Florida, United States
• Chiesi Clinical Trial - Site 840444 — Miami, Florida, United States
• Chiesi Clinical Trial - Site 840437 — Miami, Florida, United States
• Chiesi Clinical Trial - Site 840403 — Miami, Florida, United States
• Chiesi Clinical Trial - Site 840463 — Orlando, Florida, United States
• Chiesi Clinical Trial - Site 840401 — Peachtree Corners, Georgia, United States
• Chiesi Clinical Trial - Site 840478 — New Windsor, New York, United States
• Chiesi Clinical Trial - Site 840483 — Philadelphia, Pennsylvania, United States
• Chiesi Clinical Trial - Site 840474 — Kerrville, Texas, United States
• Chiesi Clinical Trial - Site 840409 — Plano, Texas, United States
• Chiesi Clinical Trial - Site 840481 — San Antonio, Texas, United States
• Chiesi Clinical Trial - Site 8455 — Durrës, Albania
• Chiesi Clinical Trial - Site 8459 — Durrës, Albania
• Chiesi Clinical Trial - Site 8457 — Elbasan, Albania
• Chiesi Clinical Trial - Site 8460 — Korçë, Albania
• Chiesi Clinical Trial - Site 8451 — Tirana, Albania
• Chiesi Clinical Trial - Site 8452 — Tirana, Albania
• Chiesi Clinical Trial - Site 8453 — Tirana, Albania
• Chiesi Clinical Trial - Site 8454 — Tirana, Albania
• Chiesi Clinical Trial - Site 8456 — Tirana, Albania
• Chiesi Clinical Trial - Site 8458 — Tirana, Albania
• Chiesi Clinical Trial - Site 840402 — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

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