Serious Asthma Events with Mometasone Furoate Plus Formoterol Compared With Mometasone Furoate

Publication date: Available online 8 December 2018

Source: Journal of Allergy and Clinical Immunology

Author(s): Cindy L.J. Weinstein, Nicholas Ryan, Tulin Shekar, Davis Gates, Stephen J. Lane, Ioana Agache, Robert A. Nathan, SPIRO Investigators

Abstract

Background

The safety of long-acting beta agonists added to inhaled corticosteroids for the treatment of persistent asthma has been controversial.

Objective

To determine whether administering formoterol in combination with mometasone furoate increases the risk of serious asthma outcomes compared to mometasone furoate alone.

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 serious asthma outcomes (adjudicated hospitalization, intubation, or death) compared to mometasone furoate alone. The key efficacy endpoint was asthma exacerbation (composite of hospitalizations ≥24 h, emergency visits <24 h requiring systemic corticosteroid, or systemic corticosteroid for ≥3 consecutive days).

Results

Among 11,729 patients (mometasone furoate-formoterol, n=5868; mometasone furoate, n=5861), a total of 81 serious asthma outcomes, all asthma-related hospitalizations, were observed in 71 patients; 45 events from 39 patients on mometasone furoate-formoterol and 36 events from 32 patients on mometasone furoate. The hazard ratio for the first serious asthma outcome in the mometasone furoate-formoterol versus mometasone furoate group was 1.22 (95% CI: 0.76 to 1.94, p=0.411). Asthma exacerbation occurred in 1487 patients; 708 on mometasone furoate-formoterol and 779 on 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 to 0.98, p=0.021).

Conclusions

The addition of formoterol to mometasone maintenance therapy did not increase the risk of serious asthma-related events and reduced the risk of asthma exacerbation.

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