Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis.

Abstract

OBJECTIVE:

To evaluate the safety and efficacy of once-daily (QD) fluticasone furoate (FF) nasal spray in children with perennial allergic rhinitis (PAR).

STUDY DESIGN:

A global, randomized, double-blind, placebo-controlled study.

SUBJECTS AND METHODS:

Pediatric patients (aged 2-11 years; n = 558) with PAR received once-daily placebo, FF 110 microg, or FF 55 microg for 12 weeks. Efficacy was evaluated by nasal symptom scores. General safety and corticosteroid-specific safety (nasal and ophthalmic examinations, and hypothalamic-pituitary-adrenal assessments) were assessed.

RESULTS:

No findings of clinical concern were identified from the safety assessments. For primary efficacy analysis of mean change from baseline over the first 4 weeks of treatment in daily reflective total nasal symptom score, FF 55 microg demonstrated significant improvement (P = 0.003) compared with placebo; however, the improvement for FF 110 microg versus placebo did not reach statistical significance (P = 0.073).

CONCLUSION:

FF QD was well tolerated and demonstrated efficacy in children aged 2 to 11 years with PAR.

• Authors: Jorge F Máspero, Andres Rosenblut, Albert Finn Jr, Junghee Lim, Wei Wu, Edward Philpot
• Journal: Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery (Otolaryngol Head Neck Surg) Vol. 138 Issue 1 Pg. 30-7 (Jan 2008) ISSN: 0194-5998 [Print] England
• PMID: 18164990 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Androstadienes
• Anti-Allergic Agents
• Fluticasone

Topics

• Administration, Oral
• Androstadienes (administration & dosage, pharmacokinetics)
• Anti-Allergic Agents (administration & dosage, pharmacokinetics)
• Child
• Child, Preschool
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Fluticasone
• Follow-Up Studies
• Humans
• Male
• Rhinitis, Allergic, Perennial (blood, drug therapy)
• Treatment Outcome