Efficacy and safety of levocetirizine on symptoms and health-related quality of life of children with perennial allergic rhinitis: a double-blind, placebo-controlled randomized clinical trial
Abstract
BACKGROUND: This randomized study examined the efficacy and safety of levocetirizine in pediatric patients with perennial allergic rhinitis. Health-related quality of life (HRQL) was also investigated, which is particularly relevant in children because of the effects of rhinitis on learning, social activities, and comorbidity.
OBJECTIVE: To evaluate the effect of levocetirizine on the Total 4 Symptoms Score, the 50% response rate, the Pediatric Rhinitis Quality of Life Questionnaire (PRQLQ), and investigators' global evaluation of symptom improvement.
METHODS: Double-blind, placebo-controlled, randomized, multicenter trial of levocetirizine, 5 mg once daily for 4 weeks, in 306 children with perennial allergic rhinitis aged 6 to 12 years. There were 154 children in the levocetirizine arm and 152 in the placebo group who completed daily diary cards, and the PRQLQ and investigators' global evaluations were conducted at 3 visits.
RESULTS: The levocetirizine group showed a significant improvement in 2-week and 4-week Total 4 Symptoms Score compared with placebo (P = .001 and P = .008, respectively). The 50% response rate for the first 2 weeks was 12.3% for the levocetirizine group compared with 3.9% for the placebo group (P = .01). The investigators' global evaluation also favored levocetirizine, because 57.1% of the children in the levocetirizine group were considered markedly or moderately improved compared with 44.7% in the placebo group. Levocetirizine also provided a…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 306 participants or records.
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