Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients

Primary objective To show the superiority of CHF 1535 (BDP/FF) pMDI (800/24 μg per day) over BDP HFA pMDI (800 μg per day) in terms of change from baseline to the entire treatment period in average pre-dose morning peak expiratory flow (PEF) in adult asthmatic patients not adequately controlled on high doses of ICS or on medium doses of ICS plus LABA. Secondary objective To evaluate the effect of CHF 1535 pMDI on clinical outcome measures and other lung function parameters and to evaluate the safety and tolerability profile.

This was a phase III, multinational, multicentre, randomised, double-blind, double-dummy, active-control, 2-arm parallel group study designed to demonstrate the superiority of CHF 1535 (200/6 μg FDC; 800/24 μg/day) vs. BDP (100 μg; 800 μg/day). The study included the following phases: * Pre-Screening Phase (Visit 0): conducted within a maximum of two weeks before the screening visit (Visit 1), aimed to explain the study to patients, obtain informed consent, and provide instructions on screening procedures, including medication restrictions. * Screening Phase (Visit 1, Week -2): Patients were assessed for eligibility and transitioned to a 2-week open-label run-in period on beclomethasone dipropionate (BDP) pMDI 800 μg/day to establish a baseline . * Randomisation Phase (Visit 2, Week 0): Patients were randomised in a 1:1 ratio to receive either CHF 1535 (800/24 µg/day) or BDP (800 µg/day) for 12 weeks, with allocation centrally assigned through an Interactive Web Response System (IWRS) to ensure balanced treatment groups. * Investigational Phase (Treatment Period: Weeks 0-12): included six scheduled visits at Weeks 2, 4, 6, 8, 10, and 12 (end of treatment) to monitor efficacy and safety. Throughout this period, patients recorded their pre-dose morning and evening peak expiratory flow (PEF), rescue medication use, and asthma symptoms daily using an electronic peak flow meter. At each visit, key assessments were conducted to evaluate lung function (FEV1, FVC, and PEF), asthma symptom scores, and the use of both rescue and study medications. Vital signs, including heart rate and blood pressure, were monitored, while safety evaluations covered adverse events, serious adverse events, and laboratory assessments. * Follow-Up Phase: conducted one week (+2 days) after the final visit (Visit 8) or early termination, the follow-up phase included a phone call to assess any unresolved adverse events (AEs) or new concomitant medications. The total study duration for each participant was 16 weeks, including the 2-week run-in period, 12-week treatment phase, and 1-week follow-up. This design allowed sufficient time to evaluate the primary and secondary endpoints while ensuring a standardized baseline before randomisation.