Introduction and Objectives Asthma 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.

Methods Adults 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).

Results Time 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<0.001). Overall, the proportion of patients with any exacerbation was significantly lower with FLUT/FORM (18.2%) than with FORM (31.3%; p<0.001). Fewer patients experienced severe exacerbations with FLUT/FORM than FORM alone (FLUT/FORM 2.4%; FORM 9.6%; p<0.001). Similarly, fewer patients experienced any exacerbation with FLUT/FORM (26.8%) than with FLUT (32.8%; p=0.02) and fewer patients experienced severe exacerbations with FLUT/FORM than FLUT alone (FLUT/FORM 1.9%; FLUT 2.8%; p=0.36).

Conclusions Fluticasone/formoterol significantly reduces the risk of asthma exacerbations compared with its individual components. Combination therapy with fluticasone and formoterol in a single aerosol inhaler may help to improve asthma control and reduce the risk of asthma exacerbations that can impair patients' quality of life.