Am. J. Respir. Crit. Care Med., Volume 158, Number 1, July 1998, 213-219

Addition of Salmeterol versus Doubling the Dose of Beclomethasone in Children with Asthma

ANJA A. P. H. VERBERNE, CHRIS FROST, ERIC J. DUIVERMAN, MARION H. GROL, KAREL F. KERREBIJN, and the Dutch Paediatric Asthma Study Group

Department of Pediatrics, Subdivision of Pediatric Respiratory Medicine, Erasmus University and University Hospital/Sophia Children's Hospital, Rotterdam, The Netherlands; Department of Epidemiology and Population Sciences, London School of Hygiene and Tropical Medicine, Medical Statistics Unit, London, United Kingdom; Juliana Children's Hospital, The Hague; and Beatrix Children Clinic/University Hospital Groningen, The Netherlands

Studies in adults revealed that addition of salmeterol to a moderate dose of inhaled corticosteroid resulted in better symptom control and higher PEF compared with doubling the dose of inhaled corticosteroid. The aim of this three group study was to compare the effects of a moderate dose of beclomethasone, the same dose of beclomethasone with salmeterol, and a doubling dose of beclomethasone on lung function and symptoms in children with moderate asthma. A total of 177 children already treated with inhaled corticosteroids, were randomized in a double-blind parallel study either to salmeterol 50 µg twice daily (BDP400+salm), beclomethasone 200 µg twice daily (BDP800), or placebo (BDP400) in addition to beclomethasone 200 µg twice daily. No significant differences between groups were found in FEV₁, PD₂₀ methacholine, symptom scores, and exacerbation rates after 1 yr. Salmeterol resulted in slightly better PEF in the first months of treatment. FEV₁, and PD₂₀ methacholine significantly improved in all groups. After 1 yr mean changes in FEV₁, percent predicted were 4.3% (95% CI 1.3; 7.2), 5.8% (95% CI 2.9; 8.7), and 4.3% (95% CI 2.1; 6.5) for BDP400+salm, BDP800, and BDP400, respectively. Changes in airway responsiveness were 0.60 (95% CI 0.05; 1.14), 1.30 (95% CI 0.73; 1.87), and 0.80 (95% CI 0.33; 1.27) doubling doses. Growth was significantly slower in the BDP800 group. We conclude that no additional benefit was found of adding either salmeterol or more beclomethasone to a daily dose of 400 µg beclomethasone in this group of children with excellent compliance of medication.

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