The Efficacy, Tolerance and Acceptance of a New Fixed-Dose Salmeterol and Fluticasone Propionate Dry-Powder Inhaler—Salflumix Easyhaler® in COPD Patients in the Daily Clinical Practice

Abstract

The efficacy of the fix-dose salmeterol/fluticasone propionate combination in chronic obstructive pulmonary disease (COPD) was only shown for the original product. This investigator-initiated study aimed to prove the efficacy and safety of Salflumix Easyhaler®, a second-entry product (dry-powder inhaler) in a real-life setting. The efficacy of the therapy was assessed in 440 COPD outpatients (36.1% classified as C&D groups according to GOLD) using the COPD assessment test (CAT) and the modified Medical Research Council (mMRC). During 86 ± 30 days, the frequency of COPD with a big and very big impact on life (CAT > 20 pts); and high scores of dyspnea (mMRC ≥ 2) decreased from 60.7% and 57.5% at I visit to 15.2% and 22.6% at III visits, respectively (p < 0.001). There was a greater improvement in newly diagnosed patients than those who switched from other devices due to insufficient disease control or patient dissatisfaction with the used inhaler. Patients’ satisfaction was scored 3.2–3.5 in a 4 pts scale. Physicians scored the burden related to the use of Salflumix Easyhaler® as very low. Adherence exceeded 90%. This study supports effectiveness, satisfaction, and convenience with the use of this new product in COPD, and shows that ICS-containing DPI therapy is still improperly prescribed for patients with a low risk of COPD exacerbation in real-life settings.