title: Rupatadine oral solution in children with persistent allergic rhinitis: A randomized, double-blind, placebo-controlled study.
abstract: 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 (T4SS) 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 T4SS 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 QTc 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 H1 receptor antagonist in children with PER in both symptoms and quality of life.
authors: Allergy Diagnostic and Clinical Research Unit, Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors: Paul
authors: P
authors: Potter
authors: Jorge F
authors: JF
authors: Maspero
authors: Jan
authors: J
authors: Vermeulen
authors: László
authors: L
authors: Barkai
authors: Ildikó
authors: I
authors: Németh
authors: Rene A
authors: RA
authors: Baillieau
authors: Jesús M
authors: JM
authors: Garde
authors: Josep
authors: J
authors: Giralt
authors: Alejandro
authors: A
authors: Doménech
authors: Iñaki
authors: I
authors: Izquierdo
authors: Antonio
authors: A
authors: Nieto
mesh_terms: D000284:Administration, Oral; D000704:Analysis of Variance; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001118:Argentina; D002648:Child; D003533:Cyproheptadine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D011788:Quality of Life; D065631:Rhinitis, Allergic; D012221:Rhinitis, Allergic, Perennial / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D013019:South Africa; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D039563:Histamine H1 Antagonists, Non-Sedating; C103639:rupatadine; D003533:Cyproheptadine