Mometasone furoate/formoterol (MF/F) is under study for treatment of persistent asthma. We report findings from an investigation performed to identify overall MF/F safety and tolerability characteristics across all efficacy/safety Phase III MF/F trials.
Adverse event (AE) data from five randomized trials (two 12-week, two 26-week, and one 52-week) investigating MF/F administered via a metered dose inhaler (MDI) were analyzed. Subjects (≥ 12 years old) had persistent asthma (≥ 12 months). Investigated treatment arms in this analysis included twice-daily MF/F (100/10 mcg, 200/10 mcg, 400/10 mcg), twice-daily mometasone furoate monotherapy (MF-MDI: 100 mcg, 200 mcg, 400 mcg), twice-daily formoterol monotherapy (F-MDI: 10 mcg), and placebo.
Data from 2897 subjects randomized to 12-week (MF/F: n = 859, MF: n = 240), 26-week (MF/F: n = 373, MF: n = 380, F: n = 390, placebo: n = 384), or 52-week (MF/F: n = 271) treatments were analyzed. In the 12-week and 26-week treatment trials, the most common treatment-emergent AEs were: headache (12-week: [MF/F-200/10=7.6%, MF/F-400/10=2.0%, MF-400=3.3%]; 26-week: [MF/F-100/10=6.6%, MF/F-200/10=4.7%, MF-100=5.9%, MF-200=5.2%, F-10=3.8%, placebo=3.6%]), nasopharyngitis (12-week: [MF/F-200/10=5.1%, MF/F-400/10=4.7%, MF-400=5.4%]; 26-week: [MF/F-100/10=9.3%, MF/F-200/10=6.3%, MF-100=6.9%, MF-200=7.8%, F-10=5.1%, placebo=3.1%]), and upper respiratory tract infection (12-week: [MF/F-200/10=2.6%, MF/F-400/10=3.1%, MF-400=1.7%]; 26-week: [MF/F-100/10=5.5%, MF/F-200/10=5.8%, MF-100=9.0%, MF-200=8.3%, F-10=8.2%, placebo=7.6%]). In the 52-week treatment trial, the most common treatment-emergent AEs were headache (MF/F-200/10=23.4%, MF/F-400/10=23.8%), nasopharyngitis (MF/F-200/10=20.6%, MF/F-400/10=16.2%), and bronchitis (MF/F-200/10=12.1%, MF/F-400/10=15.4%). The incidence of serious AEs (SAEs) was low (12-week: [MF/F-200/10=1.5%, MF/F-400/10=1.2%, MF-400=1.3%]; 26-week: [MF/F-100/10=2.2%, MF/F-200/10=2.6%, MF-100=2.7%, MF-200=1.6%, F-10=1.0%, placebo-1.0%]; 52-week: [MF/F-200/10=5.0%, MF/F-400/10=6.2%]). Asthma-related SAEs were uncommon (n = 5); only one subject reported an asthma-related SAE considered treatment related (26-week: F-10 [severe asthma exacerbation]). Discontinuations due to AEs were low (12-week: [MF/F-200/10=2%, MF/F-400/10=1%, MF-400=2%]; 26-week: [MF/F-100/10=4%, MF/F-200/10=2%, MF-100=3%, MF-200=3%, F-10=5%, placebo=3%]; 52-week: [MF/F-200/10=4%, MF/F-400/10=5%]). No unusual or unexpected AEs were reported and no treatment-related deaths occurred.
We investigated the safety and tolerability of MF/F-MDI across all efficacy/safety Phase III trials, MF/F-MDI treatment was found to be consistently safe and well tolerated.
Treatment with MF/F-MDI was found to be consistently safe and well tolerated.
Jorge Maspero, Grant monies (from industry related sources) This study was funded by Schering-Plough. Dr Maspero has participated as a principal investigator in clinical trials from GlaxoSmithKline, Astra-Zeneca, Schering-Plough, and Novartis. Dr Cherrez Ojeda declares that he has no known potential conflicts of interest.; Employee Dr Nolte is an employee of Schering-Plough.; Consultant fee, speaker bureau, advisory committee, etc. Dr Maspero has served on speakers bureaus for Schering-Plough, GlaxoSmithKline, Astra Zeneca, Novartis and advisory committees for Merck and GlaxoSmithKline.; Other Editorial support was provided by Ray Beck, Jr, PhD of UBC Scientific Solutions, who was funded by Schering-Plough.; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Mometasone furoate/formoterol combination therapy is under investigation for treatment of persistent asthma.