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Background The safety of long-acting β-agonists added to inhaled corticosteroids for the treatment of persistent asthma has been controversial. Objective We sought to determine whether administering formoterol in combination with mometasone furoate increases the risk of serious asthma outcomes (SAOs) compared with mometasone furoate alone. This clinical trial is registered as NCT01471340. Methods We conducted a 26-week, randomized, double-blind trial in adolescent and adult patients (≥12 years) with persistent asthma in 35 countries with the primary objective of evaluating whether mometasone furoate–formoterol increases the risk of SAOs (adjudicated hospitalization, intubation, or death) compared with mometasone furoate alone. The key efficacy end point was asthma exacerbation (composite of hospitalization of ≥24 hours, emergency department visits of <24 hours requiring systemic corticosteroids, or use of systemic corticosteroids for ≥3 consecutive days). Results Among 11,729 patients (mometasone furoate–formoterol, n = 5,868; mometasone furoate, n = 5,861), a total of 81 SAOs, all asthma-related hospitalizations, were observed in 71 patients: 45 events from 39 patients receiving mometasone furoate–formoterol and 36 events from 32 patients receiving mometasone furoate. The hazard ratio for the first SAO in the mometasone furoate–formoterol versus mometasone furoate group was 1.22 (95% CI, 0.76-1.94; P =.411). Asthma exacerbation occurred in 1,487 patients: 708 receiving mometasone furoate–formoterol and 779 receiving mometasone furoate. The hazard ratio for the first asthma exacerbation in the mometasone furoate–formoterol versus mometasone furoate group was 0.89 (95% CI, 0.80-0.98; P =.021). Conclusions The addition of formoterol to mometasone furoate maintenance therapy did not increase the risk of serious asthma-related events and reduced the risk of asthma exacerbation. [ABSTRACT FROM AUTHOR]

Introduction. Inhaled delivery devices that are easy to use and facilitate dose tracking may lead to improved patient satisfaction and adherence. Patient satisfaction with a metered-dose inhaler (MDI) with an integrated dose counter containing a fixed-dose mometasone furoate/formoterol combination (MF/F MDI dose counter) was evaluated in subjects with persistent asthma or chronic obstructive pulmonary disease. Methods. In this multicenter study (N = 272, age range: 12-92 years), subject experience and satisfaction with MDI devices was evaluated using baseline and poststudy surveys. Subjects responded to the baseline survey based on their previous MDI experience, then received MF/F MDI 100/10 μg with the integrated dose counter for 4 weeks before completing the poststudy survey. This evaluation was part of a broader study objective to assess performance of the MF/F MDI dose counter. Results. At baseline, 52% of subjects reported being extremely satisfied with their previous MDI. After using the MF/F MDI dose counter, a relative increase of 43% in overall satisfaction was observed. Approximately 90% of subjects agreed the MF/F dose counter helped them track doses and was easy to use; >80% agreed the inhaler was of good quality and well designed. Subjects agreed the dose counter relieved anxiety about running out of medication (68%) or taking a subtherapeutic dose (65%). Nearly 80% of subjects had no reservations about the MF/F MDI dose counter, and most subjects stated they would request it from their physician (66%) and recommend it to a friend (75%). Conclusions. The MF/F MDI dose counter was found to be easy to use and have overall high patient satisfaction. [ABSTRACT FROM AUTHOR]

Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation, and periodic asthma deteriorations. This study was performed to evaluate the effect of mometasone furoate (MF)/formoterol (F) combination, 200/10 μg, administered twice daily (b.i.d.) on asthma deteriorations and pulmonary function in patients with asthma uncontrolled on medium-dose inhaled corticosteroid (ICS). After 2- to 3-week open-label run-in with MF 200 μg b.i.d., patients (≥12 years) were randomized to 26 weeks of treatment with MF/F 200/10 μg, MF 200 μg, F 10 μg, or placebo b.i.d. Coprimary end points were time to first asthma deterioration (MF/F versus F) and bronchodilation, assessed by the area under the curve of the change in forced expiratory volume in 1 second 0-12 hours (FEV1 AUC0-12h; MF/F versus MF). A total of 781 patients were randomized. Treatment with MF/F 200/10 μg reduced asthma deteriorations and clinically judged deteriorations (i.e., deterioration resulting in emergency treatment, hospitalization, or treatment with additional excluded asthma medication [i.e., systemic corticosteroids]). The proportion of patients experiencing asthma deteriorations was MF/F, 30.4%; MF, 33.9%; F, 54.0%; placebo, 55.6% (p < 0.001, MF/F versus F and placebo). There was a sixfold reduction in clinically judged deteriorations with MF/F versus F and placebo (p < 0.001). Lung function improved more rapidly with MF/F than MF and placebo. Mean change from baseline FEV1 AUC0-12h at week 12 was MF/F, 11.7% versus MF, 5.7%; F, 8.5%; and placebo, 3.9% (p < 0.001). Treatment-related AEs were rare and similar across groups. Treatment with MF/F 200/10 μg was effective in reducing the risk of asthma deteriorations. MF/F was safe and provided rapid and sustained bronchodilation in patients with asthma. [ABSTRACT FROM AUTHOR]

An abstract of the article "Efficacy and safety of combined medium-dose mometasone furoate/formoterol (MF/F) in persistent asthmatics," by Robert A. Nathan, David S. Pearlman, Hendrik Nolte, and Anjuli Nayak is presented.