Efficacy and Safety of Combined Mometasone Furoate/Formoterol 100/10ìg Twice Daily in Subjects with Asthma Inadequately Controlled on Low-Dose Inhaled Corticosteroids

Background: Asthma is a variable disease. Optimal control in clinical practice often requires the use of therapy at varying doses. Availability of treatments at multiple strengths is therefore essential. These are results from a 6-month trial of combined mometasone furoate/formoterol (MF/F) 100/10 μg administered via a metered-dose inhaler (MDI) as treatment for asthma deterioration (ie, severe asthma exacerbation) and bronchoconstriction in asthmatics previously treated with low-dose inhaled corticosteroids (ICS).

Methods: In a randomized, multicenter, double-blind, placebo-controlled study in asthma subjects (≥12 y) on ICS with/without a long-acting β₂-agonist (LABA), subjects were assigned to 2–3 weeks of open-label MF 100 twice daily (BID), followed by 26 weeks of MF/F 100/10 μg, MF 100 F 10 or placebo (all BID). Co-primary endpoints were time to first asthma deterioration across the 26-week treatment period (MF/F vs F) and change from baseline to week 12 in serial (0−12 h) forced expiratory volume in 1 second (FEV₁) (MF/F vs MF). Adverse events (AEs) were monitored.

Results: 746 subjects (mean: age=38.3 y, asthma duration=14.77 y, FEV₁ % predicted=75.08, reversibility=18.69%, Asthma Control Questionnaire=1.31) were randomized to 1 of the 4 treatment groups. MF/F increased the time to first asthma deterioration thus decreasing the proportion of subjects experiencing asthma deterioration during the study (MF/F=16.5%; vs MF=28.2% [P=.006]; vs F=44.7% [P<.001]; and vs placebo=45.7% [P<.001]). Mean FEV₁ AUC_0–12h over baseline at week 12 were MF/F=4.00 L x h; MF=2.53 L x h; F=3.83 L x h; and placebo=1.11 L x h. Low rates of AEs were observed and were similar between treatment arms.

Conclusions: In asthmatics previously treated with low-dose ICS with or without a LABA, MF/F 100/10 μg BID was more effective than placebo, MF, or F (all administered by MDI) in reducing asthma deteriorations and improving lung function.