- 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
or 100 micrograms) administered twice daily by a breath-actuated device
for 1 year.
- Growth was evaluated monthly; other safety variables and pulmonary
function were evaluated periodically.
- Children eligible for the study had normal growth rates as defined
by height measurements (one measurement taken 6 to 18 months before
the study and one at screening) between the 5th and 95th percentiles
and growth velocity between the 10th and 97th percentiles.
- The mean height increases from baseline to 52 weeks were 6.15 +/-
0.17 cm, 5.94 +/- 0.16 cm and 5.73 +/- 0.13 cm in patients treated with
twice daily doses of placebo, fluticasone propionate 50 micrograms,
and fluticasone propionate 100 micrograms, respectively (p=0.308 overall).
At the end of the treatment, corresponding values for mean growth velocity
were 6.10 +/- 0/17, 5.91 +/- 0.16, and 5.67 +/- 0.13 cm/year with placebo,
fluticasone propionate 50 micrograms and 100 micrograms, respectively
(p=0.313, overall). Corresponding values for mean change from
baseline in growth velocity were -0.11 +/- 0.15, -0.40 +/- 0.20,
-0.46 +/- 0.15 cm/year, respectively (p=0.380, overall).
- Changes in height at the end of treatment were comparable to normal
growth rates for patients of similar age.
- Skeletal maturation at baseline was comparable to chronologic age
at baseline for all treatment groups. At the end of 1 year of
treatment, the mean change from baseline in skeletal age was 1.13 +/-
0.06 years, 1.13 +/1 0.06 years, and 0.95 +/- 0.05 years in patients
treated with twice daily doses of placebo, fluticasone propionate 50
micrograms, and fluticasone propionate 100 micrograms, respectively
- The target enrollment size of 90 patients per treatment group was
chosen to provide 80% power of detecting a 1.0 cm per year difference
in height velocity between treatment groups.
- Only 66% of prepubescent patients in the placebo group completed
the 52-seek treatment period compared with more than 80% of patients
in each of the two treatment groups.
- No significant difference were noted among treatment groups with
respect to drug-related adverse events, clinical laboratory tests, and