Rupatadine oral solution improves rhino‐conjunctive symptoms control in children with 6‐11 years weighing ≥25 kg with persistent allergic rhinitis

Abstract

Background Clinical trials with the newer 2nd generation antihistamines in children under the age of 12 years have been performed previously but further studies are needed in order to show efficacy and safety in the most unfavourable clinical conditions such as persistent allergic rhinitis (PER). Rupatadine oral solution was developed for children with allergic rhinitis in view of its rapid onset of action and its lack of relevant side effects. These advantages were confirmed previously in a phase III study in children 6-11 years. Objective To assess the efficacy and safety of rupatadine (RUP) oral solution in a subgroup of children between 6 and 11 years weighing ≥25 kg with PER. Methods A subanalysis was performed from a previous placebocontrolled study carried out in patients between 6-11 years diagnosed as PER according to ARIA criteria. This analysis included patients with a positive prick test, weight ≥25 kg and basal nasal symptoms score (including rhinorrhea, nasal blockage, sneezing and nasal itching assessment) ≥24 obtained in 4 days throughout the 2-week screening period. Patients were allocated to treatment with either RUP oral solution (1 mg/ml) or placebo during 6 weeks. The dose was 5 ml of oral solution. The main efficacy endpoint was the change from baseline of the nasal (4TSS) and global symptoms (5TSS) score at 4 and 6 weeks of treatment. Furthermore the assessment of children’ sq uality of life at 4, 6w eeks by means of PRQLQ was also evaluated.