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Efficacy and safety of formoterol turbuhaler® when added to inhaled corticosteroid treatment in children with asthma
Author(s) -
Zimmerman Barry,
D'Urzo Anthony,
Bérubé Denis
Publication year - 2004
Publication title -
pediatric pulmonology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.866
H-Index - 106
eISSN - 1099-0496
pISSN - 8755-6863
DOI - 10.1002/ppul.10404
Subject(s) - formoterol , medicine , bronchodilator , placebo , anesthesia , asthma , evening , terbutaline , corticosteroid , morning , formoterol fumarate , inhalation , budesonide , physics , alternative medicine , pathology , astronomy
Abstract This double‐blind, placebo‐controlled, randomized, parallel‐group, multicenter study was conducted in 302 children aged 6–11 years with asthma not optimally treated with inhaled corticosteroids alone. Patients continued with their existing dose of inhaled corticosteroids and in addition received placebo, formoterol 4.5 μg or formoterol 9 μg b.i.d., for 12 weeks (all delivered via Turbuhaler®). Terbutaline was available as reliever medication. The primary efficacy variable was change from baseline in morning peak expiratory flow (PEF); secondary efficacy variables included forced expiratory volume in 1 sec (FEV 1 ), serial PEF measured over 12 hr, evening PEF, asthma symptom score, and quality of life. Compared with placebo, formoterol 4.5 μg and 9 μg improved morning PEF by 8 l/min ( P = 0.035) and 11 l/min ( P = 0.0045), respectively. Evening PEF and FEV 1 were also significantly increased compared with placebo, with no statistically significant difference between formoterol doses. Lung‐function improvements compared with placebo were greater in the middle of the day. Twelve‐hour average serial PEF after 3 months increased by 24 l/min (95% CI, 9, 39 l/min) in the formoterol 9‐μg group, and by 14 l/min (95% CI, 0, 29 l/min) in the formoterol 4.5‐μg group. The incidence of severe exacerbations in both formoterol groups was numerically lower than in the placebo group, indicating that formoterol may have the potential to improve exacerbation control in children. Both formoterol doses were well‐tolerated, and tolerance to the drug's bronchodilator effect was not observed. Formoterol provided sustained improvements in lung function and was well‐tolerated in children with asthma suboptimally treated with inhaled corticosteroids alone. Pediatr Pulmonol. 2004; 37:122–127. © 2004 Wiley‐Liss, Inc.