Improvements in asthma outcomes following 1 year of treatment with salmeterol/fluticasone or fluticasone alone when stepped up to achieve guideline-defined total control

Abstract

Rationale The aim of asthma management guidelines is to achieve and maintain control, however, the benefits of this approach have not been formally studied. Methods Patients with uncontrolled asthma, stratified according to prior medication (S1: ICS-naïve; S2: low-dose ICS; S3: moderate-dose ICS), were randomized to either salmeterol/fluticasone propionate (Seretide ®/Advair ®; SFC) or fluticasone propionate (Flixotide ®/Flovent ®; FP). Treatment was stepped-up every 12 weeks until GINA/NIH-defined Total Control was achieved (or maximum dose reached) in Phase I (12 to 36 weeks) and then maintained at that dose in Phase II (until week 52). Asthma Quality of Life Questionnaire (AQLQ) scores, pre-bronchodilator FEV 1, and exacerbation rates were assessed. Results Large, clinically meaningful improvements in mean overall AQLQ scores were seen for SFC and FP across all strata in Phase I (S1: 1.5 vs 1.3, p=0.053; S2: 1.3 vs 1.0, p<0.001; S3: 1.1 vs 0.8, p=0.005) and Phase II (S1: 1.6 vs 1.4, p=0.081; S2: 1.3 vs 1.2, p=0.008; S3: 1.2 vs 1.0, p=0.006), with near-maximal scores in both groups at endpoint. The increase in FEV 1 was significantly greater with SFC than FP alone in all strata, in both Phase I and II. The mean annual rate of exacerbations requiring oral corticosteroids and/or hospitalization or emergency visits were low in both treatment groups but significantly lower with SFC vs FP in each stratum (S1: 0.07 vs 0.12; p<0.001; S2: 0.12 vs 0.17; p=0.006; S3: 0.27 vs 0.36; p=0.019). Conclusions A treatment strategy that aims to achieve GINA/NIH-defined Total Control results in marked improvement in asthma outcomes, with greater improvements with salmeterol/fluticasone versus fluticasone alone.