A 2-week, crossover study to investigate the effect of fluticasone furoate nasal spray on short-term growth in children with allergic rhinitis.
BACKGROUND
It is essential to assess potential growth effects of any newly developed corticosteroid. Fluticasone furoate is a recently approved, enhanced- affinity intranasal corticosteroid with low systemic bioavailability and proven efficacy in treating allergic rhinitis.


OBJECTIVE
The aim of the current study was to assess whether treatment with fluticasone furoate nasal spray affected the short-term lower-leg growth rate in children with allergic rhinitis.


METHODS
Prepubertal children with seasonal or perennial allergic rhinitis of at least 1 year's duration were included in this single-center, randomized, double-blind, placebo-controlled, crossover study. The study consisted of 4 periods, each of 2 weeks' duration screening, then 2 treatment periods separated by a washout). Study medications were fluticasone furoate nasal spray 110 microg and placebo nasal spray, both administered QD in the morning. The primary end point, lower-leg growth rate (measured in millimeters per week), was assessed by knemometry. Adverse events were also assessed.


RESULTS
Fifty-eight patients were randomized to the study and comprised the intent-to-treat (ITT) population (mean [SD] age, 9.1 [1.4] years; 39 males, 19 females). Five patients were excluded from the ITT group due to protocol violations; thus, 53 patients (mean [SD] age, 9.0 [1.4] years; 35 males, 18 females) comprised the growth population (a de facto per-protocol group). In the growth population, the adjusted mean lower-leg growth rate was 0.40 and 0.42 mm/wk with fluticasone furoate and placebo, respectively. The difference in adjusted mean lower-leg growth rate between fluticasone furoate and placebo was -0.016 mm/wk (95% CI, -0.13 to 0.10). Fluticasone furoate was noninferior to placebo, as the lower boundary of the 95% CI was above the prespecified noninferiority margin of -0.20 mm/wk. These results were supported by the ITT analysis. Fluticasone furoate nasal spray was well tolerated and had an adverse-event profile similar to that of placebo nasal spray. Nasopharyngitis (placebo, 4; fluticasone furoate, 1) and headache (placebo, 3; fluticasone furoate, 1) were the most frequent adverse events during the treatment periods.


CONCLUSIONS
In this study, fluticasone furoate nasal spray 110 microg QD for 2 weeks had no effect on lower-leg growth rate in these prepubertal children with allergic rhinitis.
Gradman
Josefine
J
Asthma and Allergy Clinic, Children's Clinic Randers, Randers, Denmark. j.gradman@dadlnet.dk
Caldwell
Mark F
MF
Wolthers
Ole D
OD
D000281:Administration, Intranasal; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects*; D000336:Aerosols; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006130:Growth Disorders / Q000139:chemically induced* / Q000503:physiopathology; D048788:Growth and Development / Q000187:drug effects; D006801:Humans; D035002:Lower Extremity / Q000254:growth & development*; D008297:Male; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000336:Aerosols; D000730:Androstadienes; C523187:fluticasone furoate