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. (PIL

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Criteria

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.

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 COPD emphysema or mixed phenotypes.

• 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.