H1-antihistamine treatment in young atopic children: effect on urticaria
Abstract
BACKGROUND: There are few published, randomized, double-masked, placebo-controlled, clinical trials of interventions for urticaria in the pediatric population.
OBJECTIVE: To study the effect of long-term treatment with the H1-antihistamine levocetirizine on urticaria in young atopic children.
METHODS: In the randomized, double-masked, parallel-group Early Prevention of Asthma in Atopic Children Study, children with atopic dermatitis aged 12 to 24 months at enrollment received levocetirizine, 0.125 mg/kg, or matching placebo twice daily for 18 months. On a diary card, the child's caregiver recorded the days on which urticaria was observed. This was validated by the study investigator and entered into the electronic case report form, along with any additional relevant information.
RESULTS: A total of 510 atopic children (mean +/- SEM age, 19.4 +/- 0.2 months) composed the intention-to-treat population. During the subsequent 18 months, 27.5% (70/255) of the children taking levocetirizine and 41.6% (106/255) of the children taking placebo experienced urticaria (P < .001). The mean +/- SEM number of urticaria episodes was 0.71 +/- 0.11 in those receiving levocetirizine and 1.71 +/- 0.25 in those receiving placebo (P < .001). The mean +/- SEM duration of urticaria episodes was 4.43 +/- 1.57 days in those receiving levocetirizine and 5.36 +/- 1.27 days in those receiving placebo (P < .001).
CONCLUSIONS: Urticaria is common in atopic toddlers and deserves recognition as an important…
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: 510 participants or records.
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