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Systematic review of the dose-response relation of inhaled fluticasone propionate

M Masoli1, M Weatherall, S Holt

  • 1Medical Research Institute of New Zealand, Wellington, New Zealand.

Archives of Disease in Childhood
|September 24, 2004
PubMed

Insights

Inhaled fluticasone shows optimal asthma control in children between 100-200 mcg daily. Higher doses may offer additional benefits for severe asthma but carry a risk of adrenal suppression.

Area of Science:

  • Pediatric Pulmonology
  • Pharmacology
  • Clinical Medicine

Background:

  • Asthma is a common chronic respiratory disease in children.
  • Inhaled corticosteroids (ICS) are a cornerstone of asthma management.
  • Determining optimal and safe dosing of ICS in pediatric populations is crucial.

Purpose of the Study:

  • To evaluate the dose-response relationship of inhaled fluticasone propionate in children with asthma.
  • To assess the impact of fluticasone dosing on both asthma efficacy and adrenal function.
  • To identify potential plateau effects and safety concerns at different fluticasone dosages.

Main Methods:

  • Systematic review of double-blind, randomized, dose-response studies of inhaled fluticasone in children.
  • Studies included were of at least 4 weeks duration.
  • Efficacy outcomes included FEV1, peak expiratory flow, night awakenings, and beta-agonist use; adrenal function was assessed via urinary and plasma cortisol levels.

Main Results:

  • Efficacy data from 7 studies (1733 children) indicated a plateau in response between 100-200 mcg/day, with potential additional benefit at 400 mcg/day in severe asthma.
  • Adrenal function data from 5 studies (1096 children) showed no significant difference in 24-hour urinary cortisol at 100-200 mcg/day compared to placebo.
  • However, one study indicated significant overnight urinary cortisol suppression at 400 mcg/day compared to 200 mcg/day.

Conclusions:

  • The dose-response curve for inhaled fluticasone in children suggests efficacy plateaus between 100-200 mcg/day.
  • While 400 mcg/day may offer additional efficacy in severe pediatric asthma, it is associated with evidence of adrenal suppression.
  • Further data is needed to establish dose-response beyond 400 mcg/day.
Abstract

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