No growth suppression in children treated with the maximum recommended dose of fluticasone propionate aqueous nasal spray for one year.
This randomized, double-blind, placebo-controlled study of fluticasone propionate aqueous nasal spray (at a maximum recommended dose of 200 micrograms each day) administered daily for one year was conducted to evaluate its potential effects on growth, measured by stadiometry, in prepubescent children with perennial allergic rhinitis (n = 150; age 3.5 to 9.0 years). The results demonstrate equivalent growth velocity over a one-year treatment period between children receiving fluticasone propionate aqueous nasal spray and children receiving vehicle placebo. In addition, children in both treatment groups had similar increases in height over the same period. Baseline height was 119.1 cm (SE = 0.72) in the fluticasone propionate group (n = 56) and 119.0 cm (SE = 0.71) in the vehicle placebo group (n = 52). Mean height at the end of one year of treatment was 125.5 cm (SE = 0.18) in the fluticasone propionate group (n = 44) and 125.4 cm (SE = 0.19) in the vehicle placebo group (n = 39) (least-squares mean difference -0.12; 95% confidence interval [-0.600, 0.352]). The effects of fluticasone propionate on one-year growth velocity were also comparable to those of vehicle placebo. The confidence interval for the treatment difference lay within the prospectively defined equivalence bounds (of -0.8, +0.8 cm/year) and contained zero. The incidence of adverse events considered to be at least possibly drug-related did not differ between the fluticasone propionate group and the vehicle placebo group. The results of this one-year, double-blind study demonstrate that fluticasone propionate aqueous nasal spray at the maximum recommended dose of two sprays per nostril (200 micrograms) once daily was equivalent to vehicle placebo with no effects on growth rate in prepubescent children.
Allen
David B
DB
University of Wisconsin Children's Hospital, 600 Highland Ave., Madison, Wisconsin 53792, USA.
Meltzer
Eli O
EO
Lemanske
Robert F
RF
Philpot
Edward E
EE
Faris
Melissa A
MA
Kral
Kenneth M
KM
Prillaman
Barbara A
BA
Rickard
Kathleen A
KA
D000280:Administration, Inhalation; D000287:Administration, Topical; D000730:Androstadienes / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001827:Body Height / Q000187:drug effects* / Q000502:physiology*; D002648:Child; D002669:Child Welfare; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005500:Follow-Up Studies; D005938:Glucocorticoids; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy / Q000503:physiopathology; D016896:Treatment Outcome
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D000068298:Fluticasone