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Xyzal (Levocetirizine) Reduces Symptoms of Persistent Allergic Rhinitis: Presented at EAACI

By Jill Stein

PARIS, FRANCE -- June 10, 2003 -- Long-term therapy with levocetirizine (Xyzal) alleviates symptoms of persistent allergic rhinitis (PER), investigators reported here on June 9^th at the 22^nd Congress of the European Academy of Allergology and Clinical Immunology.

Claus Bachert, MD, PhD, Ghent University in Ghent, Belgium, led an international team of researchers in the Xyzal in Persistent Rhinitis Trial (XPERT), the first study to examine the long-term effects of an H1-antagonist over 6 months in patients with PER after the condition was newly classified in the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines.

Allergic rhinitis was previously divided into seasonal, perennial, and occupational, based on the length of exposure to allergens. ARIA felt this classification was suboptimal, and accordingly issued a new classification that is based on duration and severity and is subdivided into "intermittent" or "persistent" and into "mild" or "moderate-severe." PER last more than 4 days per week and more than 4 weeks, suggesting the presence of chronic inflammation.

The randomised, double blind, placebo-controlled, parallel-group, multi-center study included patients sensitised to both house dust mites and pollens and satisfied the ARIA criteria for PER with a total 5-symptom score of 6 or greater for at least 4 days during the selection week.

Overall, 724 patients were screened; 278 were randomised to levocetirizine treatment and 273 to placebo. Patients were treated for six months, and the impact of the treatment was observed using an electronic diary. The average age was 30 years; gender distribution was nearly even (56.3% female).

The Rhinoconjunctivitis Quality of Life Questionnaire was used to determine impairment of physical, emotional, and social functioning based on 28 questions across seven domains, each score ranging from 0 (no impairment) to 6 (major impairment). In addition, the more generic Health-Related Quality of Life questionnaire (the SF-36) was used.

Levocetirizine treatment resulted in a significant (P<0.001) improvement in the symptoms of rhinitis compared to placebo over the first 4 weeks (5.43 versus 6.56). This improvement was sustained over 6 months (P<0.001). Individual symptom scores were significantly decreased compared to placebo as early as Week 1 for most symptoms.

After 4 weeks, health-related quality of life was better in the levocetirizine group as measured by the Rhinitis Quality of Life questionnaire (P<0.001, 47.5% relative improvement over placebo) and SF-36 Physical Component Score (P<0.001). The difference in the Rhinitis Quality of Life overall score over the 6 months was clinically and statistically significant.

The study also found that fewer patients who were treated with levocetirizine developed co-morbidities. As a result, fewer medical resources were used for the management of PER and its co-morbidities by the active treatment group over the evaluation period.

"The results confirm that long-term treatment with levocetirizine is not only effective at treating symptoms of PER but can also significantly improve quality of life," said Dr. G. Walter Canonica, a study co-author at the University of Genoa.


[Study title: Levocetirizine Long-Term Treatment In Patients Suffering From Persistent Allergic Rhinitis. Abstract 239]

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