EP4487842A1 — An inhalable formulation of fluticasone propionate and albuterol sulfate for the treatment of asthma

USPTO Abstract

This invention relates to a method for the treatment of asthma comprising 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 aged from ≥4 years, 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 one or more of prolonging the time to first severe clinical asthma exacerbation when compared to albuterol sulfate rescue treatment, reducing the total annualized systemic corticosteroid (SCS) exposure when compared to albuterol sulfate rescue treatment, and reducing the annualized severe clinical asthma exacerbation rate, when compared to albuterol sulfate rescue treatment.. Also provided is a fixed-dose dry powder inhalation composition and dry powder inhaler for performing the method of the present invention.