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Long-Term Levocetirizine Improves Persistent Allergic Rhinitis, Study Shows : Presented at EAACI

By Michael Smith

AMSTERDAM, THE NETHERLANDS -- June 14, 2004 -- Persistent rhinitis can be successfully treated over the long term by the modern antihistamine levocetirizine, reports a team of researchers.

This finding was presented at the 23rd Congress of the European Academy of Allergology and Clinical Immunotherapy (EAACI) by Paul Van Cauwenberge, MD, of Ghent University Hospital in Ghent, Belgium. The XPERT study is the first large-scale clinical trial to demonstrate that long-term use of an anti-histamine can benefit patients with persistent allergic rhinitis, he said.

The study name is taken from the trade name of the drug: Xyzal in Persistent Rhinitis Trial (XPERT). Dr. Van Cauwenberge was one of several researchers presenting different aspects of the data derived from the study. The XPERT study was a 6-month, double-blind, placebo-controlled trial in 551 patients and was carried out in several centers in Europe.

Persistent allergic rhinitis is defined in the World Health Organization's ARIA guidelines as the presence of allergic rhinitis for 4 or more days a week for more than 4 weeks.

Such a condition can interfere with both work and sleep, Dr. Van Cauwenberge said, as well as having detrimental effects on quality of life.

The main study end point was the change in total symptom score, based on the 5 major symptoms of rhinitis: nasal congestion, sneezing, rhinorrhea, and nasal and ocular pruritus.

The symptoms were evaluated daily by patients using an electronic diary and a 4-point scale from 0, meaning no symptom, to 3, meaning a severe symptom, Dr. Van Cauwenberge said.

The researchers found that overall, levocetirizine did significantly better than placebo, reducing the total symptoms scores by about 1.14 – a difference that remained over the entire 6-month treatment period.

The drug improved 4 of the individual symptoms - sneezing, rhinorrhea, nasal and ocular pruritus – by more than 20% at every time point in the study. Nasal congestion was improved by at least 15% at every time point, he said.

Patients had persistent relief of symptoms over the entire period, regardless of seasonality, with relief starting as early as week 1 of the study. Dr. Van Cauwenberge
concluded.


254 - Efficacy results of the XPERT 6-month study

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