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Efficacy of Fluticasone Propionate on Lung Function and Symptoms in Wheezy Infants

Division of Respiratory Medicine, Department of Pediatrics, and Department of Epidemiology and Biostatistics, Erasmus University Medical Center/Sophia Children's Hospital, and Department of Pediatrics, Medical Center Rijnmond-Zuid, Rotterdam; Department of Pediatrics, Amphia Hospital, Breda; and Department of Pediatrics, Groene Hart Hospital, Gouda, The Netherlands

Correspondence and requests for reprints should be addressed to P. J. F. M. Merkus, M.D., Ph.D., Erasmus MC, Sophia Children's Hospital, P.O. Box 2060, 3000 CB Rotterdam, The Netherlands. E-mail: p.j.f.m.merkus{at}erasmusmc.nl

The role of inhaled corticosteroids in the treatment of recurrent or persistent wheeze in infancy remains unclear. We evaluated the effect of 3 months of treatment with inhaled fluticasone propionate, 200 µg daily (FP200), on lung function and symptom scores in wheezy infants. Moreover, we evaluated whether infants with atopy and/or eczema respond better to FP200 as compared with non-atopic infants. Forced expiratory flow (max_FRC) was measured at baseline and after treatment. Sixty-five infants were randomized to receive FP200 or placebo, and 62 infants (mean age, 11.3 months) completed the study. Mean max_FRC, expressed as a Z score, was significantly below normal at baseline and after treatment in both groups. The change from baseline of max_FRC was not different between the two treatment arms. After 6 weeks of treatment, and not after 13 weeks, the FP200 group had a significantly higher percentage of symptom-free days and a significant reduction in mean daily cough score compared with placebo. Separate analysis of treatment effect in infants with atopy or eczema showed no effect modification. We conclude that in wheezy infants, after 3 months of treatment with fluticasone, there was no improvement in lung function and no reduction in respiratory symptoms compared with placebo.

Key Words: fluticasone propionate • infant lung function testing • inhaled corticosteroids • recurrent wheeze • wheezy infants

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