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Fluticasone propionate in asthma: a long term dose comparison study
E Verona1, D Petrov, E Cserhati
1Medical University of Zagreb, Zagreb, Croatia. eva.verona@zg.hinet.hr
Insights
Higher dose fluticasone propionate (200 microg twice daily) improved lung function more in children with moderate to severe asthma. The 200 microg dose showed greater benefits, especially for those with more severe asthma, with similar tolerability.
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.
Background:
Few dose ranging studies have investigated optimal dosing with inhaled corticosteroids in children with asthma.
Aims:
To compare the efficacy and tolerability of fluticasone propionate 100 or 200 microg twice daily in children with moderate to severe asthma for one year.
Methods:
One year, randomised, double blind, parallel group, multicentre study. Children aged 4-11 years (n = 528) with moderate to severe asthma who had previously received high dose inhaled corticosteroids were given fluticasone propionate 100 or 200 microg twice daily for the 52 week treatment period. Efficacy (exacerbations, lung function, and symptoms) and tolerability (adverse events and cortisol levels) were measured.
Results:
There was a non-significant decreased risk of experiencing an exacerbation at any time with fluticasone propionate 200 microg twice daily compared with fluticasone propionate 100 microg twice daily. This difference reached significance among patients with more severe asthma (defined by previous inhaled corticosteroid dose >800 microg/day). Daily record card morning peak expiratory flow (PEF) in the total population improved significantly more with the higher dose of fluticasone propionate (between group difference, weeks 1-52: 11.4 l/min). Clinic visit mean PEF improved from baseline with both doses, but the response was significantly greater with the higher dose (between group difference, week 52: 17.8 l/min). Both doses were equally well tolerated and overnight urinary cortisol concentrations were unchanged or slightly increased during treatment with either dose.
Conclusion:
This long term dose comparison study shows that treatment with fluticasone propionate 200 micro g twice daily may offer benefits over a lower dose, particularly in children with more severe asthma.
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