P112 Fluticasone propionate/formoterol fumarate combination therapy reduces the risk of exacerbations compared with its individual components in patients with asthma

Introduction and ObjectivesAsthma remains uncontrolled in many patients, as indicated by exacerbations, deteriorating symptoms and impaired quality of life. A new option has been developed for the maintenance treatment of asthma, combining the inhaled corticosteroid fluticasone propionate (FLUT) with the long-acting ß2-agonist formoterol fumarate (FORM) in a single aerosol inhaler (FLUT/FORM; flutiform®). A pooled analysis of data from up to five randomised, double-blind, parallel-group phase 3 studies assessed the effects of FLUT/FORM on asthma exacerbations.MethodsAdults and adolescents with mild, moderate or severe asthma were randomised to FLUT/FORM (100/10, 250/10 or 500/20 μg twice daily), the equivalent nominal dose of FLUT monotherapy (100, 250 or 500 μg twice daily; five studies) or FORM monotherapy (10 μg twice daily; three studies) for 8 or 12 weeks. The endpoints assessed were time to first exacerbation and proportion of patients experiencing an exacerbation. Exacerbations were defined as peak expiratory flow rate >30% below baseline, awakening at night due to asthma, use of rescue medication 3–4 times per day (each on =2 consecutive days; mild-to-moderate exacerbation), need for additional therapy, or emergency visit or hospitalisation due to asthma (severe exacerbation).ResultsTime to first exacerbation (any severity) was significantly longer with FLUT/FORM (n=641) than with FLUT (n=643; p=0.01). Similarly, time to first exacerbation was significantly longer with FLUT/FORM (n=341) than FORM (n=345; p