A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma

摘要

Abstract Objectives Asthma affects over 6 million children in the United States alone. This study investigated the efficacy and long‐term safety of mometasone furoate‐formoterol (MF/F) and MF monotherapy in children with asthma. Materials and Methods This phase 3, multicenter, randomized controlled trial evaluated metered‐dose inhaler twice daily (BID) dosing with MF/F 100/10?μg or MF 100?μg in children, aged 5 to 11 years, with a history of asthma for greater than or equal to 6 months and confirmed bronchodilator reversibility, who were adequately controlled on inhaled corticosteroid/long‐acting beta‐agonist combination therapy for greater than or equal to 4 weeks. After a 2‐week run‐in on MF 100?μg BID, eligible patients received 24 weeks of double‐blind treatment and were followed for safety up to 26 weeks. The primary efficacy endpoint was the change from baseline in AM postdose 60‐minute AUC %predicted FEV1% across 12 weeks of treatment. Results A total of 181 participants received at least one dose of MF/F (n?=?91) or MF (n?=?90). MF/F was superior to MF across the 12‐week evaluation period, with a treatment advantage of 5.21 percentage points ( P ??.001). Superior onset of action with MF/F over MF was achieved as early as 5?minutes postdose on day 1. Overall, approximately 50% of participants experienced one or more treatment‐emergent adverse events, with fewer occurring in the MF/F group. Conclusions In children 5 to 11 years of age with persistent asthma, the addition of F to MF was well tolerated and provided significant, rapid, and sustained improvement in lung function compared with MF alone.