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PEDIATRICS Vol. 113 No. 2 February 2004, pp. e87-e94

ELECTRONIC ARTICLE

Twelve-Month Safety and Efficacy of Inhaled Fluticasone Propionate in Children Aged 1 to 3 Years With Recurrent Wheezing

Hans Bisgaard, MD*, David Allen, MD{ddagger}, Janusz Milanowski, MD§, Ilia Kalev, MD||, Lisa Willits, MSc and Patricia Davies, PhD

* Copenhagen University Hospital, Copenhagen, Denmark
{ddagger} University of Wisconsin Children’s Hospital, Madison, Wisconsin
§ Klinika Chorób Puc, Lublin, Poland
|| Medical University Pediatric Hospital of Pulmonary Disease, Sofia, Bulgaria
GlaxoSmithKline, Greenford, Middlesex, United Kingdom

Objective. Our aim was to compare the 12-month safety and efficacy of fluticasone propionate (FP) and sodium cromoglycate (SCG) in children aged 1 to 3 years with mild to moderate recurrent wheeze.

Methods. The study was a randomized, parallel-group, open-label multicenter study of 625 children, aged 1 to 3 years, with recurrent wheeze randomized in a 3:1 ratio to treatment for 52 weeks with FP (100 µg twice daily) via metered-dose inhaler and Babyhaler spacer device or SCG (5 mg 4 times daily) via metered-dose inhaler and Nebuhaler spacer device, respectively.

Results. There was no significant difference in mean adjusted growth rates between the 2 groups: 84.0 mm/year in the FP group versus 86.4 mm/year in the SCG group (difference FP-SCG: –2.4 mm/year; 95% confidence interval: –6.6 to 1.8). Growth comparisons were independent of age, gender, previous use of steroid, or whether measured as length and/or height. Serum and urinary cortisol concentrations showed a statistically significant suppression of 10% and 14%, respectively, but the number of patients with serum cortisol levels below the lower normal limit was reduced during the trial. Both treatments were well tolerated. The most common drug-related adverse events were cough (2% FP vs 1% SCG) and hoarseness (1% FP vs 0% SCG). One incident of cataract was observed at baseline and 1 after FP treatment; the latter had resolved after 12 months. The efficacy of FP was superior to SCG with fewer cases of symptom worsening, exacerbations, and requirements for oral steroid treatment and more symptom-free days and days without use of rescue treatment.

Conclusions. Twelve months of treatment with inhaled FP (100 µg twice daily) in preschool children aged 1 to 3 years with recurrent wheeze has no effect on growth and no other clinically important side effects but is more efficacious than SCG.

Key Words: fluticasone propionate • sodium cromoglycate • asthma • wheeze • preschool children • growth velocity • cortisol

Abbreviations: ICS, inhaled corticosteroid • FP, fluticasone propionate • BUD, budesonide • MDI, metered dose inhaler • SCG, sodium cromoglycate • DRC, daily record card • CI, confidence interval • OR, odds ratio

Received for publication May 27, 2003; Accepted Oct 14, 2003.




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