Fluticasone propionate in asthma: a long term dose comparison study

Area of Science:

• Pediatric Pulmonology
• Pharmacology
• Clinical Trials

Background:

• Optimal dosing of inhaled corticosteroids (ICS) in pediatric asthma remains understudied.
• Limited dose-ranging studies exist for ICS in children with asthma.

Purpose of the Study:

• To compare the efficacy and tolerability of fluticasone propionate at 100 microg versus 200 microg twice daily.
• To evaluate these doses in children aged 4-11 years with moderate to severe asthma over one year.

Main Methods:

• A one-year, randomized, double-blind, parallel-group, multicenter study.
• 528 children with moderate to severe asthma received fluticasone propionate 100 or 200 microg twice daily.
• Efficacy outcomes included exacerbations, lung function (peak expiratory flow), and symptoms; tolerability assessed via adverse events and cortisol levels.

Main Results:

• The higher fluticasone propionate dose (200 microg) showed significantly greater improvements in morning and clinic visit peak expiratory flow (PEF).
• A non-significant trend towards reduced exacerbations was observed with the 200 microg dose, which became significant in patients with more severe asthma (previous ICS >800 microg/day).
• Both doses were well-tolerated, with no significant changes in overnight urinary cortisol levels.

Conclusions:

• Fluticasone propionate 200 microg twice daily may offer superior benefits compared to 100 microg twice daily for children with moderate to severe asthma.
• The higher dose is particularly advantageous for children with more severe asthma.
• Long-term treatment with either dose demonstrated good tolerability.