Extrait

This study will update the original mixed treatment comparison (MTC) of fluticasone furoate/vilanterol (FF/VI) in comparison to alternative inhaled corticosteroid/long-acting beta-agonists (ICS/LABAs) in asthma (carried out in 2013; study id 200341) with recent literature (studies published since December 2012). The primary objective is to evaluate the relative treatment efficacy of FF/VI compared with alternative ICS/LABAs licensed for the treatment of Asthma, based on lung function measured as mean change from baseline in morning Peak Expiratory Flow (PEF) (averaged over the study period), and mean change from baseline in FEV1. The primary comparisons will include European Union (EU)-authorised fixed dose treatment regimens: 1) FF/VI compared with fluticasone propionate and salmeterol; 2) FF/VI compared with budesonide and formoterol; 3) FF/VI compared with budesonide propionate and formoterol; 4) FF/VI compared with fluticasone propionate and formoterol. Secondary objectives are to evaluate FF/VI versus the comparators on: 1) Yearly or annualized rate of the composite moderate/severe exacerbations; 2) Yearly or annualized rate of any exacerbations; 3) Asthma Quality of Life Questionnaire (AQLQ); Study Design: Bayesian, hierarchical, mixed treatment comparisons (MTCs) Data Source: Systematic literature review of Asthma treatments that was conducted separately. Analysis: Analyses will be conducted, contingent upon availability of comparator data. Models will include known predictors of treatment outcomes. Exacerbation endpoint will be analyzed in patients with a history of exacerbations as documented in the supporting clinical trial publications. RELVAR is a registered trademark of the GlaxoSmithKline group of companies.

Critère d'inclusion

• Asthma

Liens

• gsk