Asthma control using fluticasone propionate/salmeterol: GOAL study re-analysis using GINA 2016 guidelines

Background: Asthma management aims to improve control and reduce future risk of poor outcomes, including exacerbations. Inhaled fluticasone propionate/salmeterol (FP/SAL) is effective in achieving and maintaining control and reducing exacerbations. Aim: To evaluate the efficacy of FP/SAL in achieving asthma control, defined as per symptom domain control levels in GINA 2016, and absence of exacerbations. Methods: A post hoc analysis of the GOAL study including 3416 patients in the intent-to-treat population. At randomisation, patients were stratified by prior medication: inhaled corticosteroid (ICS)-naive (Stratum [S1])/low-dose ICS (S2)/medium-dose ICS (S3), and assigned to receive FP/SAL or FP. Primary endpoint: proportion of patients that achieved well-controlled (WC) or partially-controlled (PC) asthma and no exacerbations; secondary endpoint: WC asthma and no exacerbations. Control was evaluated during the last 4 weeks of each dose titration step. Results: In all strata, more patients achieved WC/PC asthma with FP/SAL v FP: S1, 91% v 85% (p=0.003); S2, 86% v 82% (p=0.072); S3 76% v 66% (p Conclusion: A greater proportion of patients who entered the study with uncontrolled asthma achieved WC and PC asthma according to GINA 2016 criteria with FP/SAL than with FP alone. Funding: GSK (SAM40027)