Abstract
Objective: The combination of inhaled corticosteroid (ICS) and long-acting β2-agonist is recommended for treatment of patients with persistent asthma inadequately controlled on ICS monotherapy. This study was conducted to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) administered through metered-dose inhaler (MDI) in patients with persistent asthma previously on medium- to high-dose ICS. Methods: This was a 52-week, randomized, multicenter, parallel-group, open-label, evaluator-blinded study. At baseline, 404 patients (aged ≥12 years) were stratified according to their previous ICS dose (medium or high), then randomized 2:1 to receive twice-daily treatment of MF/F (200/10 or 400/10 μg) or fluticasone propionate/salmeterol (FP/S; 250/50 or 500/50 μg). The primary endpoint was the number and percentage of patients reporting any adverse event (AE). Additional safety evaluations included plasma cortisol 24-hour area under the curve (AUC0−24 h) and ocular changes. Pulmonary function, asthma symptoms, and use of rescue medication were monitored. Results: The incidence of ≥1 treatment-emergent AE was similar across treatment groups (MF/F 200/10 μg, 77.3% [n= 109]; FP/S 250/50 μg, 82.4% [n= 56]; MF/F 400/10 μg, 79.2% [n= 103]; FP/S 500/50 μg, 76.9% [n= 50]). Rates of treatment-related AEs were also similar across treatment groups (MF/F 200/10 μg, 28.4%; FP/S 250/50 μg, 23.5%; MF/F 400/10 μg, 23.1%; FP/S 500/50 μg, 20.0%). Headache (3.7%) and dysphonia (2.7%) were the most common treatment-related AEs overall. The nature and frequency of AEs and the decreases in plasma cortisol AUC0−24 h observed with MF/F treatment were similar to those observed with FP/S treatment. Ocular events were rare (2–6% overall incidence among treatment groups); in particular, no posterior subcapsular cataracts were reported. Only three patients discontinued the study because of treatment-related ocular AEs (two for lens disorders in the MF/F 400/10 μg group; one for reduced visual acuity in the FP/S 250/50 μg group) and no asthma-related deaths occurred. Furthermore, MF/F showed numerical improvement in lung function and clinical benefits by reducing asthma symptoms and rescue medication use. Conclusions: One-year treatment with the new combination therapies – twice-daily MF/F-MDI 200/10 and 400/10 μg – is safe and well tolerated in patients with persistent asthma.
Highlights
Asthma is a chronic respiratory disease characterized by reversible bronchoconstriction, bronchial hyperresponsiveness, and inflammation, with episodes of asthma worsening occurring in response to various stimuli [1,2,3,4]
There were no asthma-related deaths or intubations, and only two patients on mometasone furoate/formoterol (MF/F) discontinued the study owing to treatment-related adverse event (AE)
Data from two shorter studies, including a 26week study (MF/F 200/10 μg, Mometasone furoate (MF) 200 μg, F 10 μg, and placebo treatment groups) [26] and a 12-week study (MF/F 200/10 μg, MF/F 400/10 μg, and MF 400 μg treatment groups) [27] indicated that no new signals were observed for MF/F compared with its monocomponents
Summary
Asthma is a chronic respiratory disease characterized by reversible bronchoconstriction, bronchial hyperresponsiveness, and inflammation, with episodes of asthma worsening occurring in response to various stimuli [1,2,3,4]. With their anti-inflammatory properties, inhaled corticosteroids (ICSs) are the first-line therapy to relieve persistent asthma symptoms of all severities [1,2,3,4]. Formoterol (F), a LABA, when administered as monotherapy, rapidly dilates airway smooth muscle and maintains control over 24 hours, thereby improving lung function and reducing asthma symptoms [16,17,18,19]
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