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A placebo controlled trial of fluticasone propionate in asthmatic children
C A MacKenzie1, E G Weinberg, E Tabachnik
1Department of Paediatrics, University of Sheffield, Western Bank, UK.
Insights
Inhaled fluticasone propionate significantly improved lung function and asthma symptoms in children. This study found the steroid treatment effective and safe for pediatric asthma management.
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Clinical Medicine
Background:
- Childhood asthma requires effective and safe treatment options.
- Inhaled corticosteroids are a cornerstone of asthma management.
- Fluticasone propionate offers high topical potency and low systemic bioavailability.
Purpose of the Study:
- To evaluate the efficacy and safety of inhaled fluticasone propionate in children with asthma.
- To compare fluticasone propionate with placebo in a pediatric asthma population.
Main Methods:
- A double-blind, randomized study involving 258 children with asthma.
- Participants received fluticasone propionate (50 micrograms twice daily) or placebo via Diskhaler for 4 weeks.
- Outcome measures included lung function (PEFR), symptom scores, beta 2-agonist use, and adrenal function.
Main Results:
- Fluticasone propionate significantly increased both morning and evening PEFR compared to placebo.
- Significant improvements were observed in symptom scores and beta 2-agonist rescue medication use.
- No significant adverse effects were noted, with basal plasma cortisol remaining within normal limits.
Conclusions:
- Inhaled fluticasone propionate at 50 micrograms twice daily is superior to placebo in treating childhood asthma.
- The treatment demonstrates a favorable safety profile with no evidence of adverse effects in pediatric patients.
Abstract:
Fluticasone propionate is a synthetic steroid for use by the inhaled route. It's high topical potency and low systemic bioavailability make it suitable for use in asthmatic children. A total of 258 children were randomised in a double-blind study to receive fluticasone propionate (50 micrograms bd) as the dry powder formulation inhaled via a Diskhaler inhaler, or matched placebo (with current therapy) for 4 weeks throughout which time diary cards were completed. During clinic visits lung function and adrenal function were measured. Fluticasone propionate produced a significantly greater increase in morning peak expiratory flow rate (PEFR) (adjusted mean difference over days 1-28, 17 l/min (95% CI; 10, 24); P < 0.001) and evening PEFR (adjusted mean difference over days 1-28, 16 l/min (95% CI; 9, 23); P < 0.001). In addition, diary card symptom scores, beta 2-agonist rescue and clinic lung function improved significantly on fluticasone propionate. There were few adverse events and basal plasma cortisol remained within the normal range. In conclusion fluticasone propionate at 50 micrograms bd is superior to placebo (current therapy) in the treatment of childhood asthma with no evidence of adverse effects.