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Side-effects of fluticasone in asthmatic children: no effects after dose reduction

Depts of ¹ Pulmonology, ² Pathology and Laboratory Medicine, ⁶ Paediatric Pulmonology, University Hospital Groningen, ³ Dept of Epidemiology and Biostatistics, Erasmus Medical Centre, Rotterdam, ⁴ Dept of Paediatrics, Medical Centre, Leeuwarden, and ⁵ Dept of Paediatrics, Division of Paediatric Pulmonology, Isala Klinieken, Zwolle, the Netherlands

CORRESPONDENCE: M.J. Visser, Dept of Pulmonology, University Hospital Groningen, P.O.Box 30,001, 9700 RB, Groningen, the Netherlands. Fax: 31 503619320. E-mail: M.Visser@int.azg.nl

Keywords: Adrenal cortex, bone metabolism, fluticasone, height, hyperresponsiveness

Received: February 25, 2004
Accepted April 20, 2004

This study was supported by GlaxoSmithKline (the Netherlands), De Stichting Astma Bestrijding, University Hospital Groningen and the University of Groningen.

To assess long-term effects and side-effects of fluticasone propionate (FP), a 2-yr study was performed, comparing a step-down dose approach (1,000 µg·day^–1, with reductions every 2 months to 500, 200 and 100 µg·day^–1 for the remainder of the study) versus a constant dose (200 µg·day^–1).

In 55 children with chronic persistent asthma, aged 6–10 yrs, airways hyperresponsiveness (AHR) and systemic side-effects (height, bone parameters and adrenal cortical function) were assessed at predetermined intervals in a double-blind prospective 2-yr study.

AHR improved after 4 months treatment with 1,000 µg·day^–1 FP followed by 500 µg·day^–1, without significant differences during long-term treatment between the two approaches. Dose-dependent reduction of growth velocity, adrenal cortical function and biochemical bone turnover was found during therapy with 1,000 and 500 µg·day^–1 FP when compared with 200 µg·day^–1.

In conclusion, doses of 1,000 and 500 µg·day^–1 fluticasone propionate are associated with marked reductions of growth velocity, bone turnover and adrenal cortical function. However, conventional doses (200 µg·day^–1 fluticasone propionate) appear to be safe in the long-term management of childhood asthma. From a safety point of view, high doses of fluticasone propionate should only be prescribed in exceptions, e.g. in persistent severe asthma.

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