Methods: An 8-week randomized, double-blind, parallel study. Patients were assigned to 2 arms: 14 received levocetirizine 5 mg and montelukast 10 mg individual tablets; 14 received levocetirizine 5 mg plus montelukast 10 mg combination tablet. Symptom scoring using the Specific Immunotherapy Questionnaire (SITQ) were obtained at baseline, then at 2 weeks, 4 weeks and 8 weeks thereafter of treatment.
Results: Patients on levocetirizine and montelukast combination tablet had significant improvement on nasal symptoms scores, eye symptom scores, total symptom scores after 2 weeks and 4 weeks of treatment (P<0.05). In patients given levocetirizine and montelukast individual tablets, only the nasal symptoms (diff=2.5, p=0.0123) were significantly improved after 2 weeks of treatment. However, the eye symptom score and total symptom score were significantly improved (p<0.05) after 4 weeks and 8 weeks of treatment. The Quality of Life (QOL) scores between the two groups were only significantly different at 8 weeks of treatment with those given the combination tablet having a significant improvement of QOL from baseline (p value=0.03), compared to those given the individual tablets. The mean difference of the symptom scores between the individual tablets and combination tablet of montelukast and levocetirizine showed no significant difference (P>0.05).
Conclusions: Treatment with the combination tablet of levocetirizine and montelukast is equally efficacious with the individual preparation in controlling nasal symptoms, eye symptoms, and total symptoms in patients with Moderate to Severe Persistent Allergic Rhinitis. The quality of life scores however, did not show significant improvement after 8 weeks of treatment with the individual tablets. Despite this, results showed no significant mean difference when compared to the change in QOL score of the individual preparation of levocetirizine and montelukast.