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Confirmed safety and efficacy of mometasone furoate/formoterol in asthma

Published online: December 8, 2018

Concerns about the safety and appropriate use of beta-agonists in the treatment of asthma prompted the United States Food and Drug Administration (FDA) to issue restrictions on the use of orally inhaled combination medicines containing inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA). In 2006, FDA also added a black box warning advising prescribers and patients about the risk of serious asthma related events, including death. However, because it was unclear whether concurrent use of an ICS with a LABA (ICS/LABA combinations) would mitigate the safety risks observed with LABA monotherapy, FDA required four manufacturers of LABA-containing asthma medicines to conduct similarly designed, but separate, studies to evaluate the risk of serious asthma-related events and asthma exacerbations with their specific ICS/LABA medicines compared to the ICS alone.

In a paper recently published in The Journal of Allergy & Clinical Immunology (JACI), Weinstein and colleagues reported on serious asthma-related outcomes (hospitalization, intubation and death) and asthma exacerbations (asthma deterioration resulting in: hospitalizations ≥24 h, emergency visits <24 h requiring systemic corticosteroid, or systemic corticosteroid for ≥3 consecutive days), observed in a 26-week study of 11,729 adult and adolescent patients with asthma enrolled in 431 clinical study centers worldwide. Patients randomly received an inhaler containing one of two possible asthma maintenance medications: mometasone furoate alone (MF) or mometasone furoate plus formoterol fumarate (MF/F). Neither the researchers, physicians nor patients knew which inhaler the patient received; however, the assigned dose of inhaled corticosteroid was determined by the patients’ previous asthma maintenance medication and the physician’s assessment of the patients’ current level of asthma control. Patients who had been receiving any daily asthma medication could participate if they had between one and four asthma exacerbations within the past year. However, patients could not participate if they had a history of life-threatening asthma or their asthma was currently unstable.

The researchers’ analysis showed that patients taking MF or MF/F had a similar low risk of asthma-related events: all of the observed asthma-related events were hospitalizations; no patients required intubation for asthma and no patients died due to asthma after 26 weeks, even if they stopped taking their assigned asthma medication early. In addition, the study showed a significantly lower risk of asthma exacerbation in patients receiving MF/F.  

The authors concluded that these results alleviate concerns of serious asthma-related risks when the LABA (formoterol) and the ICS (mometasone furoate) are used concurrently and reinforce the value of MF/F as an asthma maintenance therapy by reducing asthma exacerbations.  

Collectively, the data from the four individual studies served as the basis for FDA’s removal of the black box warning for all ICS/LABA asthma medications.  

The Journal of Allergy and Clinical Immunology (JACI) is an official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.