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

<p>Inclusion Criteria:</p><ul><li>Adults aged ≥ 40 years, with COPD and with chronic bronchitis.</li><li>Current smokers or ex-smokers (history of ≥10 pack years).</li><li>Post-bronchodilator FEV1 &lt;50% of the patient predicted normal value and FEV1/FVC ratio &lt; 0.7.</li><li>At least, one moderate or severe COPD exacerbation in the previous year.</li><li>CAT score ≥10.</li><li>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.</li></ul>

<p>Exclusion Criteria:</p><ul><li>Subjects with current asthma.</li><li>Subjects with moderate or severe COPD exacerbation 4 weeks before study entry and randomisation</li><li>Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.</li><li>Subjects with primary diagnosis of emphysema not related to COPD.</li><li>Subjects with known respiratory disorders other than COPD.</li><li>Subjects with lung volume reduction surgery.</li><li>Subjects with active cancer or a history of lung cancer.</li><li>Subjects under Roflumilast treatment within 6 months before study entry.</li><li>Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.</li><li>Subjects with clinically significant cardiovascular condition.</li><li>Subjects with neurological disease.</li><li>Subjects with clinically significant laboratory abnormalities.</li><li>Subjects with moderate or severe hepatic impairment.</li></ul>