A 2-Week, Crossover Study to Investigate the Effect of Fluticasone Furoate Nasal Spray on Short-Term Growth in Children with Allergic Rhinitis

• Published in: Clinical therapeutics Vol. 29; no. 8; pp. 1738 - 1747
• Main Authors: Gradman, Josefine, MD, Caldwell, Mark F., MB, ChB, Wolthers, Ole D., MD, DMSci
• Format: Journal Article
• Language: English
• Published: Belle Mead, NJ EM Inc USA 01.08.2007; Excerpta Medica; Elsevier Limited
• Subjects: Administration, Intranasal; Adrenal Cortex Hormones - administration & dosage; Adrenal Cortex Hormones - adverse effects; Aerosols; Allergies; Androstadienes - administration & dosage; Androstadienes - adverse effects; Asthma; Bioavailability; Biological and medical sciences; Child; Children & youth; Cross-Over Studies; Double-Blind Method; Female; fluticasone furoate; glucocorticoid; Growth and Development - drug effects; Growth Disorders - chemically induced; Growth Disorders - physiopathology; Hay fever; Hormones; Humans; Immunology; Internal Medicine; knemometry; Lower Extremity - growth & development; Male; Medical Education; Medical sciences; nasal spray; Non tumoral diseases; Otorhinolaryngology. Stomatology; Pediatrics; Pharmacokinetics; Pharmacology. Drug treatments; Rhinitis; Rhinitis, Allergic, Perennial - drug therapy; Rhinitis, Allergic, Seasonal - drug therapy; short-term growth; Steroids; Time Factors; Treatment Outcome; Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology; Denmark; short-term growth; fluticasone furoate; glucocorticoid; nasal spray; knemometry; Human; Short term; Immunopathology; Allergy; Nose disease; Rhinitis; Growth; Spraying; Intranasal administration; Crossover study; Glucocorticoid; Fluticasone furoate; ENT disease; Child
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2007.08.017

Abstract 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 µg 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. Conclusion: In this study, fluticasone furoate nasal spray 110 µg QD for 2 weeks had no effect on lower-leg growth rate in these prepubertal children with allergic rhinitis.