Real-life effectiveness of asthma treatment with a fixed-dose fluticasone/formoterol pressurised metered-dose inhaler – Results from a non-interventional study. (October 2017)

• Record Type: Journal Article
• Authors: Schmidt, O.; Petro, W.; Hoheisel, G.; Kanniess, F.; Oepen, P.; Langer-Brauburger, B.
• Is Part Of: Respiratory medicine. Volume 131(2017)
• Page Start: 166
• Page End: 174
• Publication Date: 2017-10
• Subjects: Asthma control -- Quality of life -- Fluticasone -- Formoterol -- Fixed combination -- Non-interventional; Chest -- Diseases -- Periodicals; Chest -- Diseases -- Great Britain -- Periodicals; Respiratory organs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Appareil respiratoire -- Maladies -- Périodiques; Thorax -- Maladies -- Périodiques; Appareil respiratoire -- Maladies -- Traitement -- Périodiques; Electronic journals; 616.2
• DOI: 10.1016/j.rmed.2017.08.017
• Languages: English
• ISSNs: 0954-6111

Abstract

Abstract: Objective: 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. Methods: 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. Results: 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 ± 5.0 at baseline to 19.8 ± 4.5 at 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. Conclusion: 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. Highlights: Prospective, non-interventional study in 1563 community-based patients with asthma. First real-life data set with fluticasone propionate/formoterol fumarate (FP/FORM). Clinically important improvement in asthma control and quality of life with FP/FORM. Decreased incidence of severe asthma exacerbations with FP/FORM. Improvements were evident 1 month after treatment start and sustained for 12 months.