IngentaConnect Once-Daily Fluticasone Propionate is as Effective as Twice-Daily ...

Abstract:

Objective: To test the hypothesis that once-daily treatment with fluticasone propionate is as effective as twice-daily treatment in children with well controlled asthma.

Design: Multicentre, randomised, double-blind, parallel-group study.

Setting: General practice, 86 UK centres.

Patients: 328 children with a diagnosis of asthma and a mean age of 10 years (range 4–16 years), mean duration of asthma of 5.5 years, and a mean percentage predicted forced expiratory volume in 1 second prior to randomisation of 93% were randomised.

Interventions: Patients entered a 4-week, open run-in period, receiving fluticasone propionate 50

g twice daily via a Diskus™ inhalation device. Patients whose asthma was well controlled according to predefined criteria were randomised to receive either fluticasone propionate 100

g at night and placebo in the morning (once daily [od] group; n = 151) or fluticasone propionate 50

g twice daily (bd) [bd group; n = 177] for 8 weeks.

Main outcome measures: Mean morning peak expiratory flow over the 8 weeks of treatment, recorded daily, adjusted for baseline, age, height and sex.

Results: The 90% CI for the treatment difference in morning peak flow (bd–od) in the intention-to-treat population was –1.9 to 5.3 L/min, demonstrating clinical equivalence between bd and od administration. Fifteen patients withdrew from the study due to asthma-related problems, ten patients from the od group and five from the bd groups (p = 0.10). Both groups remained well controlled in terms of lung function, symptoms and use of relief medication throughout the study.

Conclusions: Once-daily treatment with fluticasone propionate 100

g at night is as effective as 50

g twice daily in children with well controlled mild-to-moderate asthma.

The full text electronic article is available for purchase. You will be able to download the full text electronic article after payment.

$62.95 plus tax Refund Policy

Once-Daily Fluticasone Propionate is as Effective as Twice-Daily Treatment in Stable, Mild-to-Moderate Childhood Asthma