Objective: To determine whether inhaled fluticasone propionate has lon
g-term effects on growth in children with persistent asthma. Study des
ign: In a double-blind, randomized, parallel-group, multicenter study,
325 prepubescent children with persistent asthma and normal growth ra
tes were treated with placebo or inhaled fluticasone propionate powder
50 mu g or 100 mu g administered twice daily by a breath-actuated dev
ice for 1 year. Growth was evaluated monthly, whereas other safety var
iables and pulmonary function were evaluated periodically. Results: Th
e prepubescent patients showed no statistically significant difference
s in mean height, mean growth velocity, or mean skeletal age between a
ny 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 mu g group, and 5.73 +/-
0.13 cm in the fluticasone propionate 100 mu g group (p = 0.308, overa
ll). Conclusions: Prepubescent children treated with fluticasone propi
onate 50 mu g and 100 mu g 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.