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Placebo‐controlled study of montelukast and budesonide on short‐term growth in prepubertal asthmatic children
Author(s) -
Pedersen Søren,
Agertoft Lone,
WilliamsHerman Debora,
Kuznetsova Olga,
Reiss Theodore F.,
Knorr Barbara,
Dass S. Balachandra,
Wolthers Ole D.
Publication year - 2007
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.20666
Subject(s) - medicine , montelukast , placebo , budesonide , asthma , crossover study , corticosteroid , anesthesia , confidence interval , leukotriene e4 , randomized controlled trial , wheeze , leukotriene , alternative medicine , pathology
Background Inhaled corticosteroids and anti‐leukotriene agents are widely used in the treatment of pediatric asthma. Although data on the effect of corticosteroids on growth are available, there are few such data on anti‐leukotriene agents. The aim of this study was to assess the influence of montelukast on short‐term lower leg growth rate (LLGR) in prepubertal children with asthma. Methods Forty‐two boys (6‐ to 12‐year old) and 29 girls (6‐ to 11‐year old) with mild asthma were randomized to 1 of 2 crossover arms, with two treatment sequences per arm: montelukast 5 mg once daily/placebo or inhaled dry powder budesonide 200 µg twice daily/placebo. Budesonide was used as a positive control to ensure that the method was sensitive enough to detect a suppression of LLGR. The 3‐week double‐blind treatment period was followed by a 3‐week washout. Primary outcome was LLGR over the 3‐week treatment, measured by knemometry. Results Ninety‐four percent of patients completed the study. Mean LLGR was similar between patients receiving montelukast and placebo treatments: mean difference, −0.02 mm/week [95% confidence interval −0.14, 0.11]. Mean LLGR in patients receiving budesonide was significantly less than for those receiving placebo (difference of −0.16 mm/week [−0.25, −0.06], P = 0.002). Mean LLGR was similar for patients taking placebo in the two arms (0.43 and 0.44 mm/week). Conclusion Montelukast 5 mg did not significantly affect short‐term LLGR in prepubertal children. Pediatr Pulmonol. 2007; 42:838–843. © 2007 Wiley‐Liss, Inc.