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[The effect of a single dose of formoterol using an aerosol inhaler in asthmatic children. A randomized, controlled,
P Lebecque1, S Vliers, T De Saint-Moulin
1Pneumologie Pédiatrique, Cliniques St-Luc, Université Catholique de Louvain, Bruxelles, Belgique.
Insights
Inhaled formoterol, a long-acting beta-2-agonist, demonstrated a significantly longer duration of action compared to salbutamol in children with asthma. This study highlights formoterol
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Respiratory Medicine
Background:
- Asthma management in children requires effective bronchodilators.
- Long-acting beta-2-agonists (LABAs) offer sustained bronchodilation.
- Formoterol is a novel LABA with potential for improved asthma control.
Purpose of the Study:
- To compare the duration of action of inhaled formoterol versus salbutamol in pediatric asthma patients.
- To evaluate the efficacy of different formoterol dosages.
- To assess the safety profile of formoterol in this population.
Main Methods:
- Double-blind, randomized, cross-over study design.
- 16 children (8-12 years) with moderate to severe asthma participated.
- Inhaled treatments included placebo, salbutamol (200 mcg), and formoterol (12 or 24 mcg).
- Lung function (FEV1, PEF) was measured over 8-12 hours post-inhalation.
Main Results:
- Formoterol showed significant improvement over placebo for FEV1 at 8 hours (p=0.006) and PEF at 12 hours (p=0.01).
- Formoterol's PEF improvement was significant compared to salbutamol at 8 hours (p=0.03).
- No significant lung function differences were observed between 12 mcg and 24 mcg formoterol doses.
- Minimal side-effects were reported for formoterol.
Conclusions:
- Inhaled formoterol provides a significantly longer duration of bronchodilation compared to salbutamol in children with asthma.
- Formoterol is effective and well-tolerated in pediatric asthma patients.
- The 12 mcg and 24 mcg doses of formoterol exhibited similar efficacy and safety profiles.
Abstract:
The duration of action of inhaled formoterol, a new long-acting beta-2-agonist, was compared to inhaled salbutamol and placebo in a double-blind, randomized, cross-over study in 16 children (8-12 years old) with stable moderate to serve asthma. Mean baseline FEV1 was 68 +/- 8% predicted. On the 4 study days, baseline FEV1 was within 15% of the FEV1 on visit 1. Two-three days apart, each patient inhaled either placebo, salbutamol (200 micrograms) formoterol (12 or 24 micrograms). FEV1 and PEF were measured repeatedly during 8 and 12 hours respectively. After formoterol, improvement over placebo remained significant at 8 hours for FEV1 (p = 0.006) and 12 hours for PEF (p = 0.01). When compared to salbutamol, it was significant at 8 hours for PEF (p = 0.03). There were no significant differences in lung function when comparing the 12 micrograms and 24 micrograms doses of formoterol. Side-effects were minimal.
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