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

Abstract

The objective of this study was to evaluate the efficacy and safety of fluticasone furoate (FF) nasal spray 55 and 110 microg 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 microg once daily significantly improved the daily rTNSS compared with placebo. FF 55 microg once daily was only numerically better for rTNSS and iTNSS. Secondary pre-dose iTNSS and overall response to therapy were significant with FF 110 microg. The significant findings for FF 110 microg 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.

Fluticasone Furoate Nasal Spray is Effective and Well Tolerated for Perennial Allergic Rhinitis in Adolescents and Adults

“…The only adverse events that were reported in at least 3% of patients in either group and were more common with FFNS than placebo were epistaxis (15 and 8%, respectively) and nasopharyngitis (5 and 1%, respectively). These results corroborate previous findings in perennial and seasonal allergic rhinitis [16][17][18][19][20][21][22][23][24][25] and are consistent with the low absolute bioavailability (Ͻ0.5%) of fluticasone furoate. 15 FFNS was also well tolerated in a randomized, double-blind, placebo-controlled study involving 12 months of daily treatment of perennial allergic rhinitis.…”

Safety and efficacy of fluticasone furoate nasal spray in Japanese children 2 to <15 years of age with perennial allergic rhinitis: A multicentre, open-label trial

“…The percentage of patients with quantifiable plasma levels of FF in the 2e5 years group was low and comparable to that in the 6e14 years group, indicating low systemic exposure both in older and younger children as young as 2 years. The absence of quantifiable plasma levels of FF in most children after 2 or 12 weeks of FFNS 55 and 110 mg was reported in a clinical study in non-Japanese children, 15,16 which is consistent with the results in this study. In adult nonJapanese healthy male and female volunteers, bioavailability of FFNS was assessed as low, 0.5%.…”

“…In clinical studies in non-Japanese children aged 2 to <12 years, FFNS 55 and 110 mg had similar AE profiles to the placebo. 15,16 In these studies FFNS 55 and 110 mg were reported to be well tolerated, which is consistent with the results in this study. The absence of quantifiable plasma levels of FF in most patients 0.5e2 h after the last dose in the 12-week treatment period demonstrates low systemic exposure of FFNS 55 mg.…”

“…Although well studied in healthy volunteers and patients with AR, including non-Japanese children aged 2e11 years with PAR or SAR, 15,16 the clinical efficacy, safety, and systemic exposure of FFNS in Asian children, including Japanese children, have, to our knowledge, not been investigated. Therefore, we conducted two clinical studies to evaluate the efficacy and safety of FFNS 55 mg in Japanese children.…”

Treatment of Allergic Rhinitis: Anticholinergics, Glucocorticotherapy, Leukotriene Antagonists, Omalizumab and Specific-Allergen Immunotherapy

“…Symptomatic relief of allergic rhinitis begins 8 hours after administration and lasts for 24 hours (Máspero et al, 2008;Nathan RA et al, 2008;Vasar et al, 2008;Baroody et al, 2009;Meltzer et al, 2009). …”