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)

Chiesi

Status and phase: Enrolling; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04636814

2020-003648-97 (EudraCT Number)

CLI-06001AA1-05

Details and patient eligibility

About

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.

Enrollment: 3,980 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,980 participants in 4 patient groups, including a placebo group

CHF6001 1600µg

Experimental group

Treatment:

Drug: CHF6001 1600µg

CHF6001 3200µg

Experimental group

Treatment:

Drug: CHF6001 3200µg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Roflumilast

Active Comparator group

Treatment:

Drug: Roflumilast