Real-life effectiveness of asthma treatment with a fixed-dose fluticasone/formoterol pressurised metered-dose inhaler - Results from a non-interventional study.

Abstract

Prospective, non-interventional study of fixed-dose inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) combination therapy with fluticasone propionate/formoterol fumarate (FP/FORM) across a spectrum of community-based patients with asthma in a real-life setting. In FP/FORM-treated patients aged ≥12 years, asthma control (Asthma Control Test™ [ACT]), incidence of severe exacerbations, lung function, quality of life (asthma quality of life questionnaire [AQLQ]) and adverse events (AEs) were assessed over one year. Almost 40% (n=555) of the full analysis population (N=1410) were receiving ICS/LABA therapy prior to enrolment; 69.8% completed the study. Asthma control (mean ACT±standard deviation) improved from 16.3±5.0at baseline to 19.8±4.5at study end. ACT scores were significantly (p<0.0001) higher than baseline at all observation timepoints, including the first assessment at 4-6 weeks. The percentage of patients with asthma control increased (baseline: 30.9%; study end: 62.4%), and the percentage of patients with ≥1 severe asthma exacerbation decreased (12 months before: 35.8%; during study: 5.9%). Lung function (forced expiratory volume in one second, peak expiratory flow) improved from baseline to each observation timepoint (p<0.0001 for all). Improvement in asthma status was accompanied by ameliorated quality of life: AQLQ scores improved significantly from baseline to all observation timepoints (p<0.0001 for all). AEs accorded with the summary of product characteristics. After study completion, 70% of patients continued FP/FORM treatment. In this one-year study, FP/FORM treatment was associated with clinically relevant improvements in asthma status in a diverse population of patients under real-life conditions.