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Published ahead of print on November 5, 2004, doi:10.1164/rccm.200402-227OC

Am. J. Respir. Crit. Care Med., Volume 171, Number 4, February 2005, 328-333

A more recent version of this article appeared on February 15, 2005
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Submitted on March 3, 2004
Accepted on November 3, 2004

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

Ward Hofhuis1, Els C Van der Wiel1, Eveline M Nieuwhof1, Wim CJ Hop2, Marjo J Affourtit3, Frank J Smit4, Anja APH Vaessen-Verberne5, Florens GA Versteegh6, Johan C de Jongste1, and Peter JFM Merkus1*

1 Department of Pediatric Pulmonology, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands, 2 Department of Epidemiology and Biostatistics, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands, 3 Department of Pediatrics, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands, 4 Department of Pediatrics, Medical Center Rijnmond-Zuid, Rotterdam, The Netherlands, 5 Department of Pediatrics, Amphia Hospital, Breda, The Netherlands, 6 Department of Pediatrics, Groene Hart Hospital, Gouda, The Netherlands

* To whom correspondence should be addressed. 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 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 (V'maxFRC) 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 V'maxFRC in Z score was significantly below normal at baseline and after treatment in both groups. The change from baseline of V'maxFRC 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 to 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 treatment with fluticasone there was no improvement in lung function and no reduction in respiratory symptoms compared to placebo.
Key words: Wheezy infants Recurrent wheeze Infant lung function testing Inhaled steroids Fluticasone propionate




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