Pharmacotherapy consists of oral and intranasal H1 antihistamines, intranasal corticosteroids, oral and intranasal decongestants, intranasal anticholinergics, intranasal cromolyn and leukotriene receptor antagonists. Antihistamines effectively reduce pruritis, sneezing and watery rhinorrhea and are a mainstay therapy for allergic rhinitis. Montelukast helps to reduce symptoms of allergic rhinitis that are not controlled with antihistamines alone. It reversibly inhibits cysteinyl leukotrienes (CysLTs), specifically leukotrienes D4 (LTD4), thus decreasing congestion and stuffiness associated with allergic rhinitis. Montelukast, as mono-therapy proves to be effective in improving daytime and night-time symptoms in patients with allergic rhinitis. However, a combination therapy of montelukast with antihistamines could provide enhancing and complementary effects, thereby reducing both the daytime and night time symptoms effectively. Combination of levocetirizine with montelukast has shown a significant improvement in patients with allergic rhinitis. But, only few studies are available for the effect of combination therapy of montelukast and levocetirizine on the Indian …show more content…
Clinic visits were scheduled at screening (visit 1), after a 14 day run-in period (visit 2), after every 2 weeks of treatment according to randomisation for 6 weeks (visit 3,4,5). During the run-in period patients received only Tripolidine HCl and Pseudoephedrine HCl as needed to relieve symptoms. During the randomization period patients were randomly allocated using random number table to receive Tab Levocetirizine 5mg and Montelukast 10mg in the treatment group or levocetirizine 5mg in control group once daily at bed time for 6 weeks. The allergic rhinitis and conjunctivitis symptoms were assessed on a 4-point scale (0 to 3) for both daytime (diary card completed in the evening) and night-time (diary card completed on awakening). Safety evaluation included spontaneously reported adverse events throughout the study. The primary outcome measure was the mean change of the total daytime nasal symptom scores (PDTS), defined as the average score of four daytime nasal symptoms and the secondary outcomes were the mean changes of the night-time nasal symptom scores (PNTS), daytime eye symptom scores (PES), composite symptom scores (PCS) (average score of day and night-time nasal symptom score). Statistical analysis was carried out where P<0.05) more as compared to control group from 4th week onwards in PDTS score