Cetirizine 5mg Provides Effective Relief of Worst Seasonal Allergy Symptoms in Children Ages 2-6 Years

Data from a randomized controlled trial (RCT) were analyzed to evaluate the efficacy of cetirizine 5mg syrup for relief of worst seasonal allergic rhinitis (SAR) symptom(s) in children. A company-sponsored RCT was identified in which children ages 2-6 years were randomly allocated to cetirizine 5mg syrup or placebo for SAR symptom relief. Severity scores for 4 symptoms, including sneezing, runny nose, itchy eyes, and itchy nose were recorded daily for 2 weeks. Of these symptoms, those with the highest baseline scores were predefined as the subjects’ worst symptom(s) in this analysis. When multiple symptoms shared the same highest (worst) baseline score, the daily average of ratings was calculated to represent the post-baseline rating of subjects’ worst symptom(s). Daily ratings of worst symptom(s) were averaged over 2 weeks. Change from baseline was the efficacy endpoint. Children with any baseline symptom severity score ≥1 (0=none, 3=severe) were analyzed. In these children, mean baseline worst symptom scores were 2.3 (SD=0.59;range 1-3, N=53) for cetirizine and 2.4 (SD=0.57; range 1-3, N=53) for placebo, with no significant difference between groups (P=0.481). Over 2 weeks, the LS mean change from baseline worst symptom score for cetirizine was -1.3 (SE=0.08, N=53) and -1.0 (SE=0.08; N=53) for placebo (cetirizine versus placebo, P<0.001). Percent difference in relief achieved with cetirizine 5mg was 37.3% compared with placebo. Cetirizine 5mg syrup effectively relieves subjects’ worst symptom(s), including sneezing, runny nose, itchy eyes, and itchy nose, in children ages 2-6 years with SAR.