A 52-week, Randomized, Double-blind, Double-dummy, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg), Parallel Group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis.

CLI-06001AA1-05

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.

2021-07-12

2027-09-11

2027-09-18

Recruiting

Early phase I

3980

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 3980, 'type': 'ESTIMATED'}}

2024-04-18