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

Eur Respir J. 2004 Sep;24(3):420-5. doi: 10.1183/09031936.04.00023904.

Abstract

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 microg.day(-1), with reductions every 2 months to 500, 200 and 100 microg.day(-1) for the remainder of the study) versus a constant dose (200 microg.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 microg.day(-1) FP followed by 500 microg.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 microg.day(-1) FP when compared with 200 microg.day(-1). In conclusion, doses of 1,000 and 500 microg.day(-1) fluticasone propionate are associated with marked reductions of growth velocity, bone turnover and adrenal cortical function. However, conventional doses (< or =200 microg.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.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex / drug effects
  • Androstadienes / administration & dosage*
  • Androstadienes / adverse effects*
  • Androstadienes / therapeutic use
  • Asthma / drug therapy*
  • Bone Density / drug effects
  • Bone and Bones / drug effects
  • Bronchial Hyperreactivity / drug therapy
  • Bronchodilator Agents / administration & dosage*
  • Bronchodilator Agents / adverse effects*
  • Bronchodilator Agents / therapeutic use
  • Child
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Fluticasone
  • Growth / drug effects
  • Humans
  • Male
  • Prospective Studies

Substances

  • Androstadienes
  • Bronchodilator Agents
  • Fluticasone