Overview

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.

Eligibility

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.