Lung deposition analysis of two formulations of fluticasone/salmeterol HFA pMDI in stable asthma patients

Aim Lung deposition analysis of two formulations of fluticasone/salmeterol HFA pMDI (250/25 mcg) using functional respiratory imaging (FRI) based computational fluid dynamics (CFD) in asthmatic patients. Methods In this randomised, double-blind, double-dummy, single-dose, two-period, crossover study, 16 stable adult patients with asthma received 2 puffs of either the test (Cipla Ltd, India) or the reference product (Seretide Evohaler, UK) on the first treatment day, and the alternative treatment on the second treatment day. The two dosing days were separated by a washout period of 3-7 days. The primary comparison was based on changes in airway volumes (iVaw) and surface area (iSaw) between baseline and post treatment for the test and the reference product assessed using FRI based CFD . Results Significant post treatment changes from baseline were observed for the test and the reference product. The difference in treatment effects between the test and reference product was not statistically significant for the imaging tests. Conclusions Lung deposition analysis confirm no significant difference in the treatment effects between the two formulations of fluticasone/salmeterol HFA pMDI.