Efficacy and safety of fluticasone propionate hydrofluoroalkane inhalation aerosol in four- to eleven-year-old children with asthma: A randomized, double-blinded, placebo-controlled study

摘要

This randomized, double-blinded, placebo-controlled study assessed the efficacy and tolerability of fluticasone propionate hydrofluoroalkane delivered via metered-dose inhaler without spacer. Children ages 4 to 11 years with ≥6 months' history of asthma requiring pharmacotherapy who were outpatients at primary and secondary care centers were eligible. Fluticasone, 88 μg (n = 160) or placebo (n 81) was administered twice daily for 12 weeks. The primary efficacy end point was mean change in percent predicted morning predose clinic peak expiratory flow (PEF) from baseline to end point. Secondary end points were mean change from baseline to endpoint in percent predicted forced expiratory volume in 1 second (FEV1), morning and evening diary PEF, asthma symptom scores, daily rescue albuterol use, nighttime awakenings, duration of participation in the study, and improvement in asthma severity. Children treated with fluticasone had significantly (p = 0.003) greater improvements from baseline to endpoint in percent predicted morning predose clinic PEF (10.1% versus 3.9%) compared to children who received placebo. Morning and evening diary; PEF, FEV1, percent predicted FEV1 albuterol use, and nighttime awakenings were all significantly improved (p < 0.05) relative to placebo. The week 12 improvement in asthma severity was significantly higher in the fluticasone group (30%) than in the placebo group (16%) (p = 0.028). The adverse event profile and 12-hour overnight urinary cortisol excretion for children treated with fluticasone was comparable to that of children who received placebo. Compared to placebo, fluticasone propionate hydrofluoroalkane 88 μg twice daily significantly improved asthma symptoms and was well tolerated. Mary Ann Liebert, Inc.