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A new formulation of fluticasone propionate/salmeterol in a metered-dose inhaler (MDI HFA) allows for the reduction of a daily dose of corticosteroid and provides optimal asthma control: A randomized, non- inferiority, phase IV clinical study

Respiratory Medicine Dec 03, 2020

Kupczyk M, Majak P, Kuna P, et al. - Among adults suffering from asthma ( n = 231), this randomized, multi-center, non-inferiority, phase IV clinical study was performed to compare the efficacy as well as the safety of a new formulation of fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) delivered in a metered-dose inhaler hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) consisting of fluticasone propionate/salmeterol (500 μg/50 μg, twice daily). Patients were randomized to either the study group (managed for 12 weeks with fluticasone propionate/salmeterol MDI HFA) or a control group (received fluticasone propionate/salmeterol DPI for 12 weeks). Findings demonstrated that optimal asthma control was achieved with fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) MDI HFA, and this treatment regimen was identified to be non-inferior to fluticasone propionate/salmeterol (500 μg/50 μg, twice daily) DPI.

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