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Otolaryngol Head Neck Surg. 2008 Jan;138(1):30-7. doi: 10.1016/j.otohns.2007.10.023.

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

Author information

  • 1Fundacion CIDEA, Allergy and Respiratory Research Unit, Buenos Aires, Argentina. maspero@ciudad.com.ar

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.

PMID:
18164990
[PubMed - indexed for MEDLINE]
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