Placebo-controlled study of montelukast and budesonide on short-term growth in prepubertal asthmatic children.
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 microg 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).


CONCLUSIONS
Montelukast 5 mg did not significantly affect short-term LLGR in prepubertal children.
Pedersen
Søren
S
University of Southern Denmark, Kolding Hospital, Kolding, Denmark. spconsult@post1.tele.dk
Agertoft
Lone
L
Williams-Herman
Debora
D
Kuznetsova
Olga
O
Reiss
Theodore F
TF
Knorr
Barbara
B
Dass
S Balachandra
SB
Wolthers
Ole D
OD
D000085:Acetates / Q000494:pharmacology* / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000494:pharmacology* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001827:Body Height / Q000187:drug effects*; D019819:Budesonide / Q000494:pharmacology* / Q000627:therapeutic use; D002648:Child; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007866:Leg / Q000254:growth & development*; D008297:Male; D011804:Quinolines / Q000494:pharmacology* / Q000627:therapeutic use; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D019819:Budesonide; C093875:montelukast