Double-blind trials of azelastine nasal spray monotherapy versus combination therapy with loratadine tablets and beclomethasone nasal spray in patients with seasonal allergic rhinitis

Background: Azelastine hydrochloride is an H-1-receptor antagonist with ant iinflammatory properties that is available in the US as Astelin Nasal Spray for the treatment of seasonal allergic rhinitis. The symptoms of seasonal allergic rhinitis can initially be treated with monotherapy using either an antihistamine or an intranasal comcosteroid. Patients whose symptoms do no t respond adequately are often prescribed a combination of both an antihist amine and an intranasal corticosteroid. Objective: Three multicenter, randomized, double-blind studies were conduct ed to determine whether patients with moderate-to-severe symptoms of season al allergic rhinitis who had responded inadequately to monotherapy with eit her an oral antihistamine or an intranasal corticosteroid, and who were can didates for combination therapy with both an oral antihistamine and an intr anasal corticosteroid, could be effectively treated with azelastine nasal s pray monotherapy. Methods: Following a 1- to 2-week washout period, patients were randomized to 7 days of double-blind treatment with either azelastine nasal spray (2 s prays per nostril bid, 1.1 mg/day) monotherapy or combination therapy with oral loratadine (Claritin, one 10-mg tablet/day) plus intranasal beclometha sone dipropionate monohydrate (Beconase AQ, 2 sprays per nostril bid, 336 m u g/day). Efficacy was determined at the end of the study by both a physici an assessment of the need for additional anti-rhinitis medication and a pat ient global evaluation of therapeutic effectiveness. The three studies were conducted at 71 investigational sites during the 1998 spring allergy seaso n. Three separate studies were conducted to verify the reproducibility of t he new study design. Results: In all three studies a total of 1,070 patients were randomized to double-blind treatment. There were no statistically significant differences in the percentage of patients treated with azelastine nasal spray versus p atients treated with a combination of loratadine tablets and beclomethasone nasal spray who did not require additional anti-rhinitis medication (32% t o 45% and 39% to 46%, respectively). The patient global evaluation indicate d that 77% to 84% of the patients treated with azelastine nasal spray had s ymptomatic improvement and 85% to 90% of the patients treated with loratadi ne tablets and beclomethasone nasal spray had symptomatic improvement. The most commonly reported adverse experience with azelastine nasal spray was a transient aftertaste (8%), while the most commonly reported adverse experi ence with loratadine tablets and beclomethasone nasal spray in combination was headache (6%). Conclusions: Based on the percentage of patients not requiring additional a nti-rhinitis medication and the patient assessment of efficacy, azelastine nasal spray monotherapy was as effective as the combination of oral loratad ine plus intranasal beclomethasone in treating moderate-to-severe symptoms of seasonal allergic rhinitis.