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.

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