HOUSTON — The addition of formoterol to mometasone furoate was well tolerated and provided significant improvement in lung function in children with asthma compared with mometasone furoate alone, according to the results of a Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT02741271) presented at the American College of Allergy, Asthma, & Immunology Annual Scientific Meeting held November 7-11, 2019 in Houston, Texas.
Researchers evaluated 181 children aged 5 to 11 years with a history of asthma for ≥6 months with confirmed bronchodilator reversibility and whose symptoms were adequately controlled on inhaled corticosteroids/long-acting beta-agonist combination therapy for ≥4 weeks. After a 2-week run-in period with twice-daily 100 µg mometasone furoate, eligible patients received 24 weeks of treatment with formoterol (administered in a double-blind fashion) and were followed for safety through 26 weeks. The primary efficacy end point was the change in baseline in the morning post-dose 60-minute area under the curve percent predict forced expiratory volume in 1 second across 12 weeks of treatment.
The patients received either twice-daily 100/10 µg mometasone furoate-formoterol (n=91) or twice-daily 100 µg mometasone furoate alone (n=90). Across the 12-week evaluation period, mometasone furoate-formoterol was superior to mometasone furoate alone with a treatment advantage of 5.21% (P <.001). Mometasone furoate-formoterol achieved a superior onset of action at 5 minutes post-dose on day 1 compared with mometasone furoate alone. Approximately 50% of patients experienced ≥1 treatment-emergent adverse events, but fewer occurred in the mometasone furoate-formoterol group.
The researchers concluded that the addition of formoterol to mometasone furoate in children aged 5 to 11 years with persistent asthma provided significant, rapid, and sustained improvement in lung function compared with mometasone furoate alone.
Weinstein C, Gates D, Zhang X, et al. Efficacy and safety of mometasone furoate/formoterol compared with mometasone furoate in children with persistent asthma. Presented at: American College of Allergy, Asthma, & Immunology Annual Scientific Meeting 2019; November 7-11, 2019; Houston, TX. Abstract P211.