• The Journal of pediatrics · Aug 2005

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma.

    • Nancy K Ostrom, Bruce A Decotiis, William R Lincourt, Lisa D Edwards, Kathleen M Hanson, Jacqueline R Carranza Rosenzweig, and Courtney Crim.
    • Allergy and Asthma Medical Group and Research Center, A.P.C., San Diego, California 92123, USA. information@allergyandasthma.com
    • J. Pediatr. 2005 Aug 1; 147 (2): 213-20.

    ObjectiveTo evaluate efficacy, safety, health outcomes, and cost-effectiveness of fluticasone propionate (FP) versus montelukast (MON) in 342 children (6 to 12 years of age) with persistent asthma.Study DesignRandomized, double-blind, 12-week study of treatment with FP inhalation powder 50 mug twice daily or MON chewable 5 mg once daily for 12 weeks.ResultsCompared with MON, FP significantly increased mean percent change from baseline FEV1 (forced expiratory volume in 1 second) (P=.002), morning PEF (peak expiratory flow) (P=.004), evening PEF (P=.020), and percent rescue-free days (P=.002) at end point, and it significantly reduced nighttime symptom scores (P <.001) and mean total (P=.018), and nighttime (P <.001) albuterol use. Withdrawals from the study were more frequent with MON (21%) than with FP (13%). Adverse events (69% vs 71%) and mean end point to baseline 12-hour urinary cortisol excretion ratios were similar. Parents and physicians were more satisfied with FP treatment than with MON (P=.006 and P=.016, respectively, at Week 12). Mean total daily asthma-related cost per patient in the FP group was approximately one-third of that in the MON group ($1.25 vs $3.49).ConclusionFP was significantly more effective than MON in improving pulmonary function, asthma symptoms, and rescue albuterol use. Both therapies had similar safety profiles. Parent- and physician-reported satisfaction ratings were higher with FP treatment, and asthma-related costs were lower.

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