Efficacy And Safety Evaluation Of A Dry Powder Inhaler Containing Salmeterol Xinafoate 25 Mcg/Fluticasone Propionate 250 Mcg In Subjects With Asthma: A Randomized, Open Label, Comparative, Active Controlled, Parallel Groups, And Multi-Centric Study.

Abstract

Background: Dry powder inhalers have now an established role in inhalation therapy with wide variation in design characteristics impacting their suitability for use in different patient populations. SPARC device structure enables higher amount of the inhaled drug to be delivered to lungs, making possible a reduction in administered dose. Objective: This study was planned to compare efficacy and safety of SPARC device containing Salmeterol 25 mcg/Fluticasone Propionate 250 mcg with Seretide Accuhaler (GSK) containing Salmeterol 50 mcg/Fluticasone Propionate 500 mcg. Methods: This was a 4-week, randomized, open-label, active-controlled, multicenter study (N= 113) of patients aged 1860 years with asthma, reversible bronchial obstruction, and FEV1 4080% of the predicted normal. After washout from ongoing asthma treatments, there was a 2-week run-in period when patients were permitted use of rescue medication (Salbutamol metered dose inhaler). Patients who successfully competed the run-in period with FEV1 4080% of the predicted normal were randomized 1:1 to SPARC device or Seretide Accuhaler ® for a 4week treatment period. Patients received twice daily inhalation between 8.00 a.m. to 10.00 a.m. and between 8.00 p.m. to 10.00 p.m. with approximately 12 hour interval between the two doses.Results: The improvements in SPARC device group (S/FP 25/250 mcg) were similar to Seretide Accuhaler group (S/FP 50/500 mcg). The FEV1 increased by 9.73% of predicted normal value in test group and 7.82% in reference group after 4-weeks of treatment. Although the S/FP 25/250 mcg group showed a trend towards more improvement than S/FP 50/500 mcg group in evening peak expiratory flow rate, all differences in subjective and objective outcome measures were not statistically significant. None of the safety measures included in this study showed important clinical differences between treatments. Conclusion: Administered at half the dose of Seretide Accuhaler, the efficacy of Sun device is not statistically significantly different on efficacy parameters evaluated.