Levocetirizine improves health-related quality of life and health status in persistent allergic rhinitis.

Background: Allergic rhinitis is a chronic respiratory disorder with a detrimental impact on health-related quality of life (HRQOL) and health status. Enhancement and maintenance of patient function and well-being are therefore considered as essential.

Objective: To determine whether long-term treatment with levocetirizine 5mg improves HRQOL and health status in persistent allergic rhinitis (PER) patients assessed with RQLQ and SF-36 scales over a 6-month period.

Methods: The Xyzal in PER Trial (XPERT) was a multi-center, double-blind, parallel-group study. A total of 551 patients were randomized to receive levocetirizine 5mg or placebo once daily for 6 months and assessed for symptoms, HRQOL (Rhinoconjunctivitis Quality of Life Questionnaire: RQLQ) and health status (SF-36). Sensitivity of the RQLQ and SF-36 to disease severity was tested to ensure their suitability for use in PER patients. Treatment effect was assessed by means of repeated measures analyses.

Results: Over the 6-month treatment period, levocetirizine showed statistically significant improvements over placebo in HRQOL (P < 0.001 for all RQLQ domains and overall scores) and health status (P < or = 0.004 for SF-36 physical and mental summary scores; P < 0.05 for all SF-36 scales). The relative improvement of levocetirizine over placebo exceeded the predefined clinically meaningful threshold of 30% for all RQLQ scores and the improvement from baseline was 3 times the established MID for RQLQ.

Conclusion: The RQLQ and SF-36 could be used to measure HRQOL and health status in PER patients. Long-term treatment with levocetirizine provides sustained improvement of HRQOL and reduces disease burden in PER patients.