[The effect of a single dose of formoterol using an aerosol inhaler in asthmatic children. A randomized, controlled, double-blind study].
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.
Lebecque
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Pneumologie Pédiatrique, Cliniques St-Luc, Université Catholique de Louvain, Bruxelles, Belgique.
Vliers
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De Saint-Moulin
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Godding
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D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000336:Aerosols; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004361:Drug Tolerance; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D010919:Placebos; D013997:Time Factors
D000318:Adrenergic beta-Agonists; D000336:Aerosols; D001993:Bronchodilator Agents; D004983:Ethanolamines; D010919:Placebos; D000420:Albuterol; D000068759:Formoterol Fumarate
Effet d'une dose unique de formotérol par voie d'aérosol-doseur chez l'enfant asthmatique. Une étude randomisée, contrôllée, en double aveugle.