In subjects with moderate or severe persistent asthma, a combination of inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA) is a therapeutic option according to current asthma guidelines. We report safety and tolerability findings for mometasone furoate/formoterol (MF/F) administered via a metered-dose inhaler (MDI), in subjects with persistent asthma previously treated with medium-dose ICS (alone or with a LABA).
In this randomized, placebo-controlled, double-blind, double-dummy, multicenter study, a 26-week treatment phase was preceded by a 2-to-3-week, open-label, run-in phase (MF MDI 200mcg twice-daily [BID] monotherapy). Eligibility criteria included: age ≥ 12 years, asthma diagnosis ≥ 12 months, and previous treatment with a stable medium-dose ICS (alone or with a LABA) ≥ 2 weeks before screening. Subjects were randomized to 4 treatment arms (MF/F MDI 200/10mcg BID; MF MDI 200mcg BID monotherapy; F MDI 10mcg BID monotherapy; and placebo). Adverse events (AEs) and other clinical safety measures were recorded.
781 subjects were randomized (MF/F, n = 191; MF, n = 192; F, n = 202; placebo, n = 196). Baseline demographics and asthma characteristics were balanced between the treatment arms (mean age: 42.4 ± 15.4 years). The most common treatment-emergent AEs (≥ 5% of any treatment group) were nasopharyngitis (MF/F=6.3%, MF=7.8%, F=6.4%, placebo=3.6%), upper respiratory tract infection (MF/F=5.8%, MF=8.3%, F=5.9%, placebo=8.7%), and headache (MF/F=4.7%, MF=5.2%, F=3.0%, placebo=3.6%). Few treatment-related AEs were observed (MF/F=8.9%, MF=5.7%, F=5.4%, placebo=7.7%). Most AEs were mild or moderate in intensity. Discontinuations due to AEs during the double-blind treatment period were low (MF/F=2%, MF=3%, F=4%, placebo=4%) and few serious AEs (SAEs) occurred (MF/F, n = 6; MF, n = 3; F, n = 3; placebo, n = 3). Asthma-related SAEs included severe viral infection (MF/F, n = 1), mild asthma (MF, n = 1), and severe asthma (F, n = 1); only 1 SAE (F, severe asthma) was considered possibly treatment-related. No deaths occurred.
Incidence of AEs and discontinuations due to AEs with MF/F treatment were comparable to MF and F in subjects with persistent asthma previously treated with a medium-dose ICS (alone or with a LABA).
In this 26-week study, MF/F therapy was found to be safe and well-tolerated.
Robert Nathan, Grant monies (from industry related sources) This study was funded by Schering-Plough. Dr Nathan has received grant support from Abbott, Alcon, AstraZeneca, Ception, Dey, Dyax, Genentech, GlaxoSmithKline, MAP, MedImmune, Novartis, sanofi-aventis, Schering-Plough, and TEVA. Dr Nayak has received grants, honoraria, or educational support from Abbott, AstraZeneca, sanofi-aventis, Schering-Plough, Sepracor, Teva, UCB Pharma, and Merck.; Employee Dr Nolte is an employee of Schering-Plough.; Consultant fee, speaker bureau, advisory committee, etc. Dr Nathan has served on speakers bureaus for AstraZeneca, Genentech, GlaxoSmithKline, Novartis, sanofi-aventis, Schering-Plough and UCB and as a consultant for Genentech, GlaxoSmithKline, Merck, Novartis, Schering-Plough, and TEVA. Dr Pearlman has served on advisory boards for AstraZeneca, Novartis, Sepracor, and Icagen and on a speaker bureau for AstraZeneca. Dr Nayak has served on advisory boards or received honoraria for speaking from Abbott, AstraZeneca, sanofi-aventis, Schering-Plough, Sepracor, Teva, UCB Pharma, and Merck.; 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.