Persistent Allergic Rhinitis and the XPERT Study

Abstract

Allergic rhinitis (AR) is a chronic disease with an increasing trend in most of the Western Countries. It may significantly impair the individual quality of life (QoL) and also represents a social burden for its economic costs. Levocetirizine (XYZAL; UCB Pharma) as a second generation, nonsedating H1-antihistamine, has been shown to be clinically effective in patients with AR in different randomized controlled trials. The XPERT (XYZAL in Persistent Rhinitis Trial) is the first large, long-term clinical study involving patients with persistent rhinitis as defined by ARIA (Allergic Rhinitis and its Impact on Asthma). The XPERT was a 6-month double-blind, placebo-controlled, multicenter, multinational trial in 551 subjects. Adults with persistent rhinitis sensitized to both grass pollen and house dust mites were randomized to receive levocetirizine 5 mg/d or placebo. Two primary objectives were considered: comparison of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score and Total 5 Symptoms Score (rhinorrhea, sneezing, nasal congestion, and nasal and ocular pruritus) (T5SS) between active and control group over a period of 4 weeks. As secondary endpoints, similar evaluations at 1 week and 3, 4, 5, and 6 months, summary scores for a general health status questionnaire (Medical Outcomes Survey Short Form 36), comorbidities, pharmacoeconomic and safety evaluations. Levocetirizine significantly improved both the RQLQ overall score and the T5SS from week 1 to 6 months (P < .001). Medical Outcomes Survey Short Form 36 summary scores were also improved in the group treated with levocetirizine with respect to placebo. Treatment cessation because of lack of efficacy, comorbidities, and overall costs of disease, and comorbidities per working patient per month (160.27 vs 108.18) were lower in the levocetirizine group. In conclusion, levocetirizine resulted to improve the quality of life and the symptoms related to AR and also to reduce the overall costs of the disease after 6 months treatment.