Background Drug selection for optimal treatment of allergic rhinitis may be difficult and involve many diverse factors.
Objective To evaluate montelukast, in the treatment of patients with seasonal allergic rhinitis, as an adjuvant to mainstay therapies, i.e., antihistamines and corticosteroids.
Methods The study was a prospective, three-phased (per lasted 2 weeks) clinical trial. In phase I, patients were separated into two groups, based on the predominating symptoms: (1) runners (patients with moderate to severe sneezing/itchy, watery nose/itchy, watery eyes), and (2) blockers (patients with moderate to severe nasal congestion). The runners received antihistamine loratidine 10 mg daily, and the blockers received intranasal corticosteroid mometasone furoate 200 µg. In phase II, if patients were dissatisfied with the initial treatment, they were assigned to receive another study drug additionally. In phase III, for the patients unsatisfied with the treatment of loratidine plus mometasone furoate, montelukast 10 mg once daily was added.
Results Of the 169 patients who entered phase I, 150 could be evaluated for treatment efficacy and safety. There were 108 runners and 42 blockers. Physicians' and patients' assessments indicated that in phase I 58 runners (60.0% of 50 runners) and 36 blockers (33.3% of six blockers) were satisfied with their therapy. In phase II, 30 runners (27.7%) and two blockers (4.7%) were satisfied with the addition of other study drug. Totally 62.6% of patients were satisfied at the end of phase I, and 84.0% at the end of phase II. Sixteen patients (66.6% of 24 patients) were satisfied with the addition of montelukast to the previous two drugs (in total, 10.6% of patients). Fourteen patients (12.2%) treated with loratadine, and three patients (0.3%) treated with mometasone, reported side-effect.
Conclusion The results of this trial indicate that 10% of patients with seasonal allergic rhinitis may be treated with the supplement of montelukast to mainstay therapy.