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)

Eligibility 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.
• * 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.