Salmeterol/fluticasone stable-dose treatment compared with formoterol/budesonide adjustable maintenance dosing: impact on health-related quality of life

Background: Improving patients' health- related quality of life ( HRQoL) is recognized as a fundamental part of asthma management. The aims of this study were to evaluate the long- term efficacy ( including symptom- free days and exacerbations) and impact on HRQoL of a stable- dose regimen of salmeterol/ fluticasone propionate ( SAL/ FP) and an adjustable maintenance dosing ( AMD) regimen of formoterol/ budesonide ( FOR/ BUD) where treatment is adjusted based on symptoms [ SAM40056]. Methods: A total of 688 outpatients with asthma receiving regular low- dose inhaled corticosteroids ( ICS) plus a long- acting beta(2)-agonist, or medium dose ICS alone participated in this randomized, double- blind, double- dummy, parallel- group, 1- year trial, which was conducted in 91 centers in 15 countries. Patients were randomized to receive 1 inhalation of SAL/ FP 50/ 250 mu g BID or 2 inhalations of FOR/ BUD 6/ 200 mu g BID during Weeks 1 - 4. For Weeks 5 - 52, patients meeting strict continuation criteria for stable asthma at Week 4 received AMD with FOR/ BUD or stable- dose SAL/ FP. Results: The percentage of symptom- free days was significantly greater ( 58.8% vs 52.1%; p = 0.034) and the annual exacerbation rate was significantly lower ( 47%; p = 0.008) with stable- dose SAL/ FP compared with FOR/ BUD AMD. A total of 568 patients completed the Asthma Quality of Life Questionnaire ( AQLQ) at least once during the study. The mean change from baseline in AQLQ overall score was numerically greater with SAL/ FP than FOR/ BUD at week 28 and week 52, but did not reach statistical significance ( p = 0.121 at Week 52). However, in a post hoc logistic regression analyses for any AQLQ improvement, significant benefits with SAL/ FP were seen at both time points ( p = 0.038 and p = 0.009, respectively). The minimally important difference of >= 0.5- point improvement in AQLQ overall score was achieved by a significantly greater number of patients receiving SAL/ FP at Week 28 ( 68% vs 60%; p = 0.049); a trend for this difference remained at Week 52 ( 71% vs 65%) ( p = 0.205). Conclusion: In this population of patients with persistent asthma, stable- dose SAL/ FP resulted in significantly greater increases in symptom- free days, a reduction in exacerbation rates, and provided greater HRQoL benefits compared with FOR/ BUD AMD.