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)

Phase 3

Active, not recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Placebo

• Registration Number: NCT04636801
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-19
• Study Start: 2021-07-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-12-29
• Study Completion: 2026-01-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3435

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHF6001 Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The time to first severe exacerbation.	Up to 52 weeks
The time to first moderate or severe exacerbation.	Up to 52 weeks
SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52.	At week 52
Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores	Up to 52 weeks
E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.	At week 52
Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average rescue medication use (number of puffs)	Up to 52 weeks
Time to study medication discontinuation for any reason.	Up to 52 weeks
Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component.	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
Change from baseline in SGRQ total and domain scores at week 52.	At week 52
The annual rate of severe exacerbation.	Up to 52 weeks

Trial Locations

Locations (447)

Chiesi Clinical Trial - Site 840402; 🇺🇸 Sheffield, Alabama, United States

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

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