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.
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 significantly greater HRQL improvement than placebo at 2 weeks (P = .01), and the frequency of adverse events did not differ significantly from those seen in the placebo group.


CONCLUSIONS
The study confirmed the efficacy of levocetirizine in relieving symptoms of perennial allergic rhinitis in children between 6 and 12 years of age. A HRQL benefit greater than placebo was shown. The treatment was well tolerated.
Potter
Paul C
PC
University of Cape Town Lung Institute, Western Cape, Republic of South Africa. ppotter@uctgsh1uct.ac.za
D017332:Cetirizine / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*
D039563:Histamine H1 Antagonists, Non-Sedating; D010879:Piperazines; C472067:levocetirizine; D017332:Cetirizine