Introduction and Objectives Poor asthma control impacts on patients' health and reduces their quality of life. Despite a rise in the proportion of patients receiving treatment, asthma remains uncontrolled in many patients. A new therapy option combining the inhaled corticosteroid fluticasone propionate (FLUT) with the long-acting ß2-agonist formoterol fumarate (FORM) in a single aerosol inhaler (FLUT/FORM; flutiform®) has been developed for the treatment of asthma. This integrated analysis of data from five randomised, double-blind, parallel-group phase 3 studies assessed the effects of FLUT/FORM compared with FLUT alone on the percentage of asthma control days.
Methods Symptomatic adult and adolescent patients with mild, moderate or severe asthma were randomly assigned to receive FLUT/FORM (100/10, 250/10 or 500/20 μg twice daily) or the equivalent nominal dose of FLUT alone (100, 250 or 500 μg twice daily) for 8 or 12 weeks. Most patients randomised to treatment had uncontrolled asthma. The percentage change in asthma control days (defined as those with no use of rescue medication, an asthma symptom score reporting no symptoms and a sleep disturbance score indicating that the patient slept through the night) was assessed from baseline to study end.
Results At baseline, the percentage of asthma control days was low in both groups (FLUT/FORM [n=623]: 12.8%; FLUT [n=623]: 12.6%). FLUT/FORM combination therapy was superior to FLUT alone for improvement in percentage of asthma control days. At study end, patients in the FLUT/FORM group experienced a mean of 62.4% asthma control days, an improvement of 49.6% from baseline, whereas FLUT treatment was associated with 54.8% asthma control days (42.2% change from baseline). FLUT/FORM provided a statistically significant improvement in asthma control days compared with FLUT alone (least-squares mean difference [95% CI]: 7.5% [3.21 to 11.84]; p<0.001).
Conclusions Fluticasone/formoterol combination therapy is superior to fluticasone monotherapy for improving the percentage of asthma control days over 8 or 12 weeks' treatment in adults and adolescents with mild, moderate or severe asthma. These data suggest the combination of fluticasone and formoterol in a single aerosol inhaler will provide an effective option for asthma maintenance therapy.