Long-term Safety and Tolerability of Two Doses of Mometasone Furoate/Formoterol (MF/F) Combination, Administered Via a Metered-dose Inhaler, for the Treatment of Moderate-to-severe Persistent Asthma

RATIONALE: The combination of mometasone furoate and formoterol (MF/F) administered via a single metered-dose inhaler (MDI) is in development for the treatment of asthma.We report findings from a randomized, parallel-group, multicenter, open-label, evaluator-blinded study assessing the long-term safety of medium- and high-dose MF/F compared to fluticasone propionate/salmeterol MDI (F/S) combination. METHODS: Patients (≥12 years) with moderate-to-severe persistent asthma previously treated with medium- to high-dose inhaled corticosteroids were randomized to twice-daily doses of either medium-dose MF/F (200/10 μg), medium-dose F/S (250/50 μg), high-dose MF/F (400/10 mg) or high-dose F/S (500/50 μg) for 1 year. The primary endpoint was the number and percent of patients reporting adverse events (AEs). RESULTS: 404 patients were randomized (medium-dose MF/F, n = 141; high-dose MF/F, n = 130; medium-dose F/S, n = 68; high-dose F/S, n = 65). Medium and high MF/F combination doses were well tolerated and were associated with AEs of frequency and nature similar to AEs observed with F/S. The most common treatment-related AEs in the MF/F group were dysphonia (medium-dose MF/F, 5.0%, high-dose MF/F, 3.1%) and headache (medium-dose MF/F, 4.3%; high-dose MF/F, 3.1%); in the F/S group, headache (medium-dose F/S, 5.9% and high-dose F/S, 1.5%) and arthralgia (medium-dose F/S, 4.4%; high-dose F/S, 1.5%). Oral candidiasis was uncommon (MF/F overall, 1.1%; F/S overall, 2.2%). Six patients experienced serious AEs that were possibly drug-related; ocular changes (high-dose MF/F, n = 4; medium-dose F/S, n = 1); and pneumonia (medium- dose MF/F n = 1). CONCLUSIONS: MF/F was well tolerated over 1 year at medium and high doses, with a safety profile similar to F/S and no unusual/unexpected AEs. Oral candidiasis was uncommon in this study.