Perennial rhinitis in the under 4s: a difficult problem to treat safely and effectively? A comparison of intranasal fluticasone propionate and ketotifen in the treatment of 2-4-year-old children with perennial rhinitis

Abstract

To compare the safety and efficacy of fluticasone propionate aqueous nasal spray (FPANS) and oral ketotifen in children aged 2-4 years with perennial rhinitis. A randomized, multicentre, double-blind, double dummy, placebo-controlled study. Paediatric patients between the ages of 2-4 years with perennial rhinitis. Rhinitis symptoms score (parent-rated), clinical evaluation of symptoms (investigator-rated) and adverse event profiles during the treatment period. Patients treated with FPANS had a significant reduction in both the total night-time rhinitis symptom assessment for weeks 4-6 (p-value 0.036), and the total daytime rhinitis symptom score over the same period (p-value 0.049). Generally, except for nasal itching/rubbing over weeks 1-3, the patients taking FPANS had lower recorded symptom scores for all individual symptoms measured. Nasal blockage, in particular, was significantly reduced over the 4-6 week period (p-value 0.027). The overall investigator-rated clinical evaluation showed substantial improvement or improvement in nine of 12 of the children taking FPANS compared with four of 14 taking ketotifen. Finally, there were no reports of serious adverse events, the incidence of drug-related adverse events was low and there was no statistical difference between the groups. FPANS may be an appropriate treatment to control the symptoms of rhinitis in children between 2 and 4 years old.