EP4678170A1 — A fixed-dose dry powder inhalation formulation of fluticasone propionate and albuterol sulfate for the treatment of asthma

USPTO Abstract

This invention relates to a method of treatment of asthma comprising a pro re nata (PRN) administration of a fixed-dose dry powder inhalation composition comprising fluticasone propionate and albuterol sulfate as a rescue medication in patients, wherein the fluticasone propionate is administered at a delivered dose of 22-59 mcg per inhalation and the albuterol sulfate is administered at a delivered dose of 92-124 mcg per inhalation, and wherein the treatment provides an improved baseline-adjusted postdose forced expiratory volume in one second (FEV<sub>1</sub>) area under the effect curve from time zero to 6 hours (AUEC<sub>0-6h</sub>) when compared to fluticasone propionate treatment and an improved baseline-adjusted trough FEV<sub>1</sub> when compared to albuterol sulfate treatment.