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Rupatadine oral solution in children with persistent allergic rhinitis: A randomized, double‐blind, placebo‐controlled study
Author(s) -
Potter Paul,
Maspero Jorge F.,
Vermeulen Jan,
Barkai László,
Németh Ildikó,
Baillieau Rene A.,
Garde Jesús M.,
Giralt Josep,
Doménech Alejandro,
Izquierdo Iñaki,
Nieto Antonio
Publication year - 2013
Publication title -
pediatric allergy and immunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.269
H-Index - 89
eISSN - 1399-3038
pISSN - 0905-6157
DOI - 10.1111/pai.12036
Subject(s) - medicine , placebo , antihistamine , randomized controlled trial , adverse effect , clinical endpoint , double blind , anesthesia , alternative medicine , pathology
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 6–11 yr with PER . Methods A multicenter, randomized, double‐blind, placebo‐controlled study was carried out worldwide. Patients between 6 and 11 yr with a diagnosis of PER according to ARIA criteria were randomized to receive either rupatadine oral solution (1 mg/ml) or placebo over 6 wk. The primary efficacy end‐point was the change from baseline of the total nasal symptoms score (T4 SS ) after 4 wk 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 T 4 SS reduction both at 4 (−2.5 ± 1.9 vs. −3.1 ± 2.1; p = 0.018) and 6 wk (−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 QT c or laboratory test abnormalities were reported. Conclusions Rupatadine oral solution (1 mg/ml) was significantly more effective than placebo in reducing nasal symptoms at 4 and 6 wk and was well tolerated overall. This is the first large clinical report on the efficacy of an H 1 receptor antagonist in children with PER in both symptoms and quality of life.