Mometasone combined with formoterol, compared with mometasone alone, to treat adult and adolescent patients with persistent asthma did not increase the risk of asthma-related adverse events and reduced the risk of asthma exacerbation, according to a study published in The Journal of Allergy and Clinical Immunology.
In a randomized, double-blind trial (SPIRO; ClinicalTrials.gov Identifier: NCT01471340), a team of investigators evaluated whether the addition of formoterol to mometasone maintenance therapy would affect asthma exacerbation and associated risks. The primary outcome measured was serious asthma, including asthma-related hospitalizations, intubations, and mortality. The main efficacy end point was asthma exacerbation, which included ≥24 hours of hospitalization, >24 hours of emergency visits requiring systemic corticosteroid administration, or systemic corticosteroid use for ≥3 consecutive days.
Of the 11,729 patients included in the study, 5868 were treated with mometasone furoate and formoterol and 5861 were treated with mometasone furoate alone. Patients who smoked were eligible to participate, but those who smoked more than 10 pack-years were excluded from the study.
The investigators reported 81 severe asthma outcomes in 71 patients (all asthma-related hospitalizations): 45 events from 39 patients and 36 events from 32 patients in the combination and mometasone furoate groups, respectively. The hazard ratio for the first serious asthma event in the combination group vs single treatment group was 1.22.
In addition, 1487 patients experienced asthma exacerbation: 708 in the combination treatment group and 779 in the single-treatment group. The hazard ratio for the first asthma exacerbation in the combination-treatment group vs single-treatment group was 0.89.
“These results alleviate concerns of serious asthma-related risks associated with long-acting beta agonists with concomitant use of inhaled corticosteroids and reinforce the value of mometasone furoate-formoterol combination therapy in maintaining asthma control,” the investigators concluded.
Disclosure: This study was funded by Merck & Co., Inc.
Weinstein CLJ, Ryan N, Shekar T, et al; for the SPIRO investigators. Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate [published online December 8, 2018]. J Allergy Clin Immunol. doi: 10.1016/j.jaci.2018.10.065