[Efficacy and safety of budesonide inhalation suspension nebulization by mesh nebulizer in Japanese infants and young children with bronchial asthma in 12-week, randomised, open study].
OBJECTIVE
This study evaluated the efficacy and safety of Budesonide Inhalation Suspension (BIS) nebulazation by mesh nebulizer in children ages 6 months to 4 years with moderate to severe persistent asthma.


METHODS
This 12-week, randomized, open study involved 30 asthmatic children. They were randomized 3 different nebulizer groups, Pari TurboBoy +LC Plus nebulizer, Pari eMotion and Omron MicroAir NE-22U. BIS administered 0.25 mg once daily (qd). Efficacy was assessed by daily card. Safety was assessed by adverse event, plasma cortisol and growth.


RESULTS
Baseline concentrations of plasma cortisol were significantly high in the group of Omron MicroAir NE-22U compared to other group. Plasma cortisol were decreased significantly at 4 weeks in Omron MicroAir NE-22U compared with baseline, but those in no subjects decreased under normal range. Asthma symptoms were improved significantly from baseline to 12-week.


CONCLUSIONS
This study demonstrate that usage of mesh nebulizer in BIS 0.25 mg qd is effective and safe in young asthmatic children.
Tezuka
Junichiro
J
Department of Pediatrics, Fukuoka National Hospital. tezuka@mfukuoka2.hosp.go.jp
Motomura
Chikako
C
Ikei
Junko
J
Ide
Koji
K
Kando
Naoyuki
N
Goto
Makiko
M
Taba
Naohiko
N
Hayashi
Daisuke
D
Murakami
Yoko
Y
Moriyasu
Yoshio
Y
Soebijanto
Keiji
K
Shibata
Rumiko
R
Okada
Kenji
K
Okada
Hiroshi
H
Nishima
Sankei
S
D000280:Administration, Inhalation; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage*; D002675:Child, Preschool; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers; D013535:Suspensions
D005938:Glucocorticoids; D013535:Suspensions; D019819:Budesonide