Growth in asthmatic children treated with fluticasone propionate. Fluticasone Propionate Asthma Study Group.
OBJECTIVE
To determine whether inhaled fluticasone propionate has long-term effects on growth in children with persistent asthma.


METHODS
In a double-blind, randomized, parallel-group, multicenter study, 325 prepubescent children with persistent asthma and normal growth rates were treated with placebo or inhaled fluticasone propionate powder 50 microg or 100 microg administered twice daily by a breath-actuated device for 1 year. Growth was evaluated monthly, whereas other safety variables and pulmonary function were evaluated periodically.


RESULTS
The prepubescent patients showed no statistically significant differences in mean height, mean growth velocity, or mean skeletal age between any of the treatment groups at any time. Over a period of 1 year, mean height (+/- SE) increased 6.15 +/- 0.17 cm in the placebo group, 5.94 +/- 0.16 cm in the fluticasone propionate 50 microg group, and 5.73 +/- 0.13 cm in the fluticasone propionate 100 microg group (p = 0.308, overall).


CONCLUSIONS
Prepubescent children treated with fluticasone propionate 50 microg and 100 microg administered twice daily for 1 year grew at rates similar to placebo-treated control subjects and at rates equal to expected growth velocity for age.
Allen
D B
DB
University of Wisconsin Children's Hospital, Madison 53792-4108, USA.
Bronsky
E A
EA
LaForce
C F
CF
Nathan
R A
RA
Tinkelman
D G
DG
Vandewalker
M L
ML
Konig
P
P
D000280:Administration, Inhalation; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005938:Glucocorticoids / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006128:Growth / Q000187:drug effects*; D006801:Humans; D008297:Male
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D005938:Glucocorticoids; D000068298:Fluticasone