Rupatadine oral solution in children with persistent allergic rhinitis: A randomized, double-blind, placebo-controlled study

Background Allergic rhinitis (AR) is one of the most common chronic diseases in childhood. No large, multicentre clinical trials in children with persistent allergic rhinitis (PER) have previously been performed. Rupatadine, a newer second-generation antihistamine, effective and safe in adults, is a promising treatment for children with AR. The aim of the present study was to evaluate the efficacy and safety of a new rupatadine oral solution in children aged 611yr with PER. Methods A multicenter, randomized, double-blind, placebo-controlled study was carried out worldwide. Patients between 6 and 11yr with a diagnosis of PER according to ARIA criteria were randomized to receive either rupatadine oral solution (1mg/ml) or placebo over 6wk. The primary efficacy end-point was the change from baseline of the total nasal symptoms score (T4SS) after 4wk of treatment. Results A total of 360 patients were randomized to rupatadine (n=180) or placebo (n=180) treatment. Rupatadine showed statistically significant differences vs. placebo for the T4SS reduction both at 4 (2.5 +/- 1.9 vs. 3.1 +/- 2.1; p=0.018) and 6wk (2.7 +/- 1.9 vs. 3.3 +/- 2.1; p=0.048). Rupatadine also showed a statistically better improvement in the children's quality of life compared with placebo. Adverse reactions were rare and non-serious in both treatment groups. No QTc or laboratory test abnormalities were reported. Conclusions Rupatadine oral solution (1mg/ml) was significantly more effective than placebo in reducing nasal symptoms at 4 and 6wk and was well tolerated overall. This is the first large clinical report on the efficacy of an H1 receptor antagonist in children with PER in both symptoms and quality of life.