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Published on: November 4, 2010
Efficacy and tolerability of formoterol Turbuhaler in children
A Von Berg1, F Papageorgiou Saxoni, S Wille
1Marien Hospital, Wesel, Germany.
Insights
Formoterol Turbuhaler effectively treats mild to moderate asthma in children. This study shows significant improvements in lung function and reduced medication use with formoterol, demonstrating good tolerability.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
Background:
- Asthma is a common chronic respiratory disease in children.
- Effective maintenance therapy is crucial for managing pediatric asthma.
- Formoterol Turbuhaler is a long-acting beta-agonist (LABA) used for asthma treatment.
Purpose of the Study:
- To evaluate the efficacy and tolerability of formoterol Turbuhaler in children with mild to moderate asthma.
- To compare two doses of formoterol (4.5 and 9 microg twice daily) against placebo.
Main Methods:
- A 12-week, randomized, double-blind, placebo-controlled trial.
- 248 children aged 6-17 years with mild to moderate asthma participated.
- Primary endpoint: change in morning Peak Expiratory Flow (PEF). Secondary endpoints included FEV1, reliever medication use, and nighttime awakenings.
Main Results:
- Formoterol 9 microg twice daily significantly improved morning PEF compared to placebo (13 l/min increase).
- Both formoterol doses significantly increased pre-bronchodilator FEV1 (5.2-6.7%) and reduced daytime reliever medication use.
- Formoterol 9 microg also significantly reduced nighttime reliever use and asthma-related awakenings.
Conclusions:
- Formoterol Turbuhaler at 4.5 and 9 microg twice daily is effective for maintenance therapy in children with mild to moderate asthma.
- Both doses were well-tolerated, showing similar tolerability to placebo.
- Formoterol demonstrates significant benefits in lung function and symptom control for pediatric asthma patients.
Abstract:
A randomised, double-blind trial was undertaken to investigate the efficacy and tolerability of formoterol Turbuhaler in children with mild to moderate asthma. After a two-week run-in, 248 children aged 6-17 years were randomised to receive formoterol 4.5 and 9 pmicro b.i.d. or placebo for 12 weeks. Morning PEF (primary variable), was significantly improved versus placebo only in the formoterol 9 pmicro b.i.d. group (13 l/min, 95% CCI 1.9, 24.2%; p = 0 .02). Both formoterol 4.5 and 9 pmicro significantly increased the pre-bronchodilator FEV1 by 5.2-6.7% (p < 0 .05) and reduced use of daytime relief medication versus placebo (p < 0 .05). Formoterol 9 pmicro significantly reduced night-time reliever use and awakenings due to asthma versus placebo (p < 0.05). Both doses of formoterol were as well tolerated as placebo. In conclusion, formoterol 4.5 and 9 micro b.i.d. is effective and well tolerated as maintenance therapy in children with mild to moderate asthma.
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