Rupatadine oral solution for 2-5-year-old children with allergic rhinitis: a safety, open-label, prospective study.

ABSTRACT:

Background

There are few clinical trials that assess the efficacy of antihistamines in very young children. Rupatadine is a second-generation antihistamine indicated for the treatment of allergic rhinitis (AR) and urticaria. In this study, AR symptoms were evaluated before and after daily 1 mg/mL rupatadine oral solution administration in 2-5-year-old children.

Methods

A multicenter open-label study was carried out in 2-5-year-old children with AR. Safety assessments were collected during the study including spontaneous adverse events, vital signs, and electrocardiogram (QTc interval). Additionally, evaluations of Total Five Symptoms Score (T5SS, including: nasal congestion; sneezing; rhinorrhoea; itchy nose, mouth, throat, and/or ears; and itchy, watery, and red eyes) were

SUBMITTER: Santamaria E 

PROVIDER: S-EPMC6128281 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature