Clinical study on the efficacy and safety of nebulized fluticasone propionate inhalation solution compared with oral prednisone in children with acute exacerbation of asthma
Abstract：Objective To investigate the efficacy and safety of fluticasone propionate (FP) inhalation solution compared with oral prednisone (PRE) in Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma.Methods This was a randomized,double-blind,double-dummy,active-controlled,parallelgroup,multi-center,non-inferiority study involving subjects (aged 4 to 16 years old,inclusive) with an acute exacerbation of asthma [to compare the morning Peak expiratory flow (AM PEF).Oral PRE once daily 2 mg/(kg· d),up to 40 mg/ d for 4 d,then 1 mg/(kg· d) or half of the original dose,up to 20 mg/d for 3 d) for 7 d.The study comprised a 7-d treatment period and a 14-d follow-up period].Results In terms of the primary efficacy endpoint mean AM PEF,the low limit of 95％ CI was-9.64 L/min,which was above the pre-defined non-inferiority margin-12 L/min.Conclusion FP inhalation solution was shown to be non-inferior to oral PRE in the treatment of acute exacerbation of asthma in Chinese pediatric and adolescent patients.FP inhalation solution demonstrates good safety.
Keywords：futicasone propionateprednisoneasthmaacute exacerbationPEF
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 708-712 )