Serious Asthma Outcomes and Asthma Exacerbations with Maintenance on Inhaled Corticosteroid (Mometasone Furoate)/Long-Acting Beta Agonist (Formoterol) Combination Compared to Step Down to Mometasone Monotherapy

Abstract Background Due to historical safety concerns with use of long-acting beta agonists in asthma, step-down from inhaled corticosteroid/long-acting beta agonist (ICS/LABA) combination therapy to ICS monotherapy is recommended once asthma control is achieved. Objective To evaluate the benefit/risk question about whether asthma patients who achieve disease control on fixed-dose ICS/LABA combination therapy, such as MF/F, should continue with this therapy or be stepped down to ICS monotherapy, such as MF. Methods Using data from 8,447 clinically stable patients with persistent asthma in the SPIRO trial who had been receiving a stable dose of ICS/LABA for ≥ 4 weeks, this post-hoc analysis evaluated the risk of SAOs (adjudicated hospitalization, intubation, or death) and AEX (composite of hospitalizations ≥ 24 h, emergency visits Results There was no significant difference in SAO risk among patients maintained on ICS/LABA with MF/F compared to those who stepped down from ICS/LABA to MF [HR 1.03 (95% CI 0.61, 1.75), p = 0.913]. The risk of AEX was significantly lower in patients maintained on ICS/LABA with MF/F compared to those who stepped down from ICS/LABA to MF [HR 0.87 (95% CI 0.78, 0.98), p = 0.020]. Conclusions In this post-hoc analysis of a large dataset, maintenance on ICS/LABA with MF/F is not associated with an increased risk of SAOs and also significantly reduces the risk of AEX compared with step-down from ICS/LABA to MF. ClinicalTrials.gov number, NCT01471340.