Efficacy and safety of once-daily fluticasone furoate nasal spray in children with seasonal allergic rhinitis treated for 2 wk

• Published in: Pediatric allergy and immunology 2009-05, Vol.20 (3), p.279-286
• Main Authors: Meltzer, Eli O., Lee, Jane, Tripathy, Ita, Lim, Junghee, Ellsworth, Anna, Philpot, Edward
• Format: Article
• Language: English
• Subjects: Administration, Intranasal; allergy-mediated response; Androstadienes - administration & dosage; Androstadienes - adverse effects; Biological and medical sciences; Child; Child, Preschool; Double-Blind Method; enhanced-affinity glucocorticoid; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; General aspects; hay fever; Humans; Male; Medical sciences; nasal symptoms; Non tumoral diseases; Otorhinolaryngology. Stomatology; pediatric patients; Rhinitis, Allergic, Seasonal - drug therapy; Rhinitis, Allergic, Seasonal - immunology; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology
• ISSN: 0905-6157; 1399-3038
• DOI: 10.1111/j.1399-3038.2008.00773.x

The objective of this study was to evaluate the efficacy and safety of fluticasone furoate (FF) nasal spray 55 and 110 μg once daily in children with seasonal allergic rhinitis (SAR). Patients (n = 554) received placebo nasal spray or FF, administered using a unique side‐actuated device, in a 2‐wk, randomized, double‐blind study. Symptoms were evaluated by patients using a 4‐point categorical scale. Efficacy assessments included reflective and instantaneous total nasal symptom scores (r/iTNSS). Primary analyses were conducted in patients aged 6–11 yr in the intent‐to‐treat population (ITT); the 2–11 yr group provided supportive analyses. In patients aged 6–11 yr, FF 110 μg once daily significantly improved the daily rTNSS compared with placebo. FF 55 μg once daily was only numerically better for rTNSS and iTNSS. Secondary pre‐dose iTNSS and overall response to therapy were significant with FF 110 μg. The significant findings for FF 110 μg were supported by analyses in the entire ITT population of 2–11 yr olds. Both doses of FF were well tolerated. These study results suggest that FF nasal spray administered once daily for 2 wk is well tolerated and effective for the treatment of SAR symptoms in children aged 2–11 yr.