Clinical Research Directory

Inclusion Criteria: * Adults aged ≥40 years. * Confirmed diagnosis of COPD according to GOLD criteria. * Post-bronchodilator FEV₁/FVC \<0.70 on spirometry. * Severe airflow limitation (FEV₁ \<50% predicted). * History of frequent exacerbations, defined as ≥2 moderate exacerbations or ≥1 severe exacerbation requiring hospitalisation during the previous 12 months. * Receiving optimised inhaled therapy with LABA + LAMA, with or without ICS, according to clinical indication. * Clinically stable at the time of enrolment, with no acute COPD exacerbation. * Able to provide written informed consent and comply with study visits and treatment. Exclusion Criteria: * Diagnosis of bronchial asthma or other significant chronic respiratory disease. * Active respiratory infection, pneumonia, tuberculosis, or current acute COPD exacerbation. * Significant uncontrolled cardiovascular disease or clinically important cardiac arrhythmia. * Severe hepatic impairment or significant liver disease. * Known allergy or contraindication to roflumilast or azithromycin/macrolides. * History of significant QT prolongation or use of medicines with a major risk of QT prolongation. * Current or recent long-term treatment with roflumilast or prophylactic azithromycin/macrolide therapy. * Patients requiring systemic corticosteroids or antibiotics for an acute exacerbation at the time of enrolment. * Pregnant or breastfeeding women. * Patients with conditions likely to interfere with study treatment, follow-up, or outcome assessment.