Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)

This was a Phase III, multicenter, randomized, double-blind, double-dummy, active-controlled, 2-arm parallel-group study designed to evaluate the non-inferiority of CHF 1535 100/6 µg pMDI (400/24 µg/day) versus Symbicort® Turbohaler® 160/4.5 µg (640/18 µg/day) in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). The study included the following phases: * Screening and Run-in Phase (Visit 1, Weeks -6 to 0): Patients underwent eligibility assessments, including spirometry and medical history review. Eligible participants entered a 6-week open-label run-in period with Symbicort® Turbohaler® 160/4.5 µg (640/18 µg/day) to establish baseline parameters and standardize therapy before randomization. * Randomization Phase (Visit 2, Week 0): Patients meeting eligibility criteria were randomized in a 1:1 ratio to receive either CHF 1535 100/6 µg pMDI (400/24 µg/day) or Symbicort® Turbohaler® 160/4.5 µg (640/18 µg/day) for 24 weeks. Randomization was performed via an Interactive Web Response System (IWRS) to ensure balanced treatment allocation. * Investigational Phase (Treatment Period: Weeks 0-24): Patients attended scheduled visits at Weeks 4, 12, 18, and 24 to assess treatment efficacy and safety. Daily assessments included pre-dose morning Peak Expiratory Flow (PEF), rescue medication use, and COPD symptom scores, recorded using an electronic diary. At each visit, lung function (FEV1, FVC, IC, and PEF), COPD symptom scores, and rescue medication use were evaluated. Vital signs (heart rate, blood pressure), adverse events (AEs), serious adverse events (SAEs), and laboratory assessments were monitored throughout the study. * Follow-Up Phase: A safety follow-up phone call was conducted 7-14 days after the final visit (Week 24) or early termination to assess any unresolved adverse events (AEs) or newly reported concomitant medications. The total study duration per participant was 30 weeks, including the 6-week run-in period, 24-week treatment phase, and follow-up assessment.