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)

Chiesi

Status and phase: Active, not recruiting; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Experimental: CHF6001 3200µg; Drug: Experimental: CHF6001 1600µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04636801

2020-003666-40 (EudraCT Number)

CLI-06001AA1-04

Details and patient eligibility

About

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.

Enrollment: 3,435 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,435 participants in 3 patient groups, including a placebo group

CHF6001 1600µg

Experimental group

Treatment:

Drug: Experimental: CHF6001 1600µg

CHF6001 3200µg

Experimental group

Treatment:

Drug: Experimental: CHF6001 3200µg

CHF6001 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo