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BackgroundAzelastine hydrochloride (AZE) is a selective, non-sedating H1 antagonist with anti-inflammatory and mast cell stabilizing properties, which can be used as an alternative to intranasal corticosteroids. The objective of this study was to evaluate the efficacy of the new formulation of 0.15% AZE compared to that of the placebo at a dosage of two sprays per nostril twice daily for 4 weeks in patients with perennial allergic rhinitis (PAR).Materials and methodsA total of 581 subjects were randomized in this double-blind (DB) placebo-controlled trial (NCT00712920) that compared 0.10% (1,096 μg daily) and 0.15% AZE (1,644 μg daily) to the placebo in PAR patients. The study consisted of a 7-day single-blind placebo lead-in period and a 28-day DB treatment period. The primary endpoint was the change from baseline in the 12-h reflective total nasal symptom score (rTNSS) for the entire 28-day study period of 0.15% AZE, two sprays per nostril BID compared to the placebo. The efficacy and safety of 0.15% AZE were compared to the placebo.ResultsLeast square (LS) mean improvement from baseline in the morning (AM) and evening (PM) combined rTNSS was statistically significant for the 0.15% AZE group (p = 0.04) compared to the placebo group. LS mean improvement from baseline in the AM and PM combined rTNSS was 4.10 (4.26) units for 0.15% AZE and 3.81 (3.99) for 0.10% AZE. For individual symptoms, there was a statistically significant change in the LS mean (p = 0.04) improvement from baseline on the 12-h reflective assessment for the 0.15% AZE group for runny nose. Further numerical improvements were shown for itchy nose, nasal congestion, runny nose, and sneezing compared to the placebo. No deaths or serious adverse events related to the study medication were reported.ConclusionThe present formulation of 0.15% AZE is safe and effective in relieving PAR symptoms. It effectively relieves nasal and non-nasal symptoms. Clinical Trial RegistrationClinicalTrials.gov, identifier: NCT00712920.

Allergic rhinitis (AR) is one of the most common allergic diseases, especially in economically developed countries, including Russia. The main goal of AR therapy is the control achievement over the disease symptoms, the minimizing of the future exacerbations risks and side effects. Antihistamines and glucocorticosteroids are the main classes of medicines used in all allergic diseases, including AR. According to the Federal Clinical Guidelines for Allergic rhinitis the use of the intranasal corticosteroids in combination with antihistamines is recommended on the second stage of therapy and higher. Both classes of medicines have a complementary effect on the allergic inflammation pathogenesis main stages. The intranasal corticosteroids and antihistamines using allows the delivery of the medicines to the allergic inflammation area directly. Modern intranasal corticosteroids have a high affinity that provides the high efficacy in the low concentrations using and the insignificant systemic bioavailability. The review presents the key characteristics of the olopatadine and mometasone furoate nasal spray in a fixed combination, which registered in the Russian Federation recently. This combination is recommend for use in adults and children over 12 y.o. with allergic rhinitis. The pharmacological characteristics of the nasal spray components including the action mechanism described. The main clinical studies results presented, that confirmed the high efficacy and safety of olopatadine/mometasone furoate combination in AR patients. The olopatadine and mometasone furoate fixed combination ensures the rapid onset and the long-lasting effect with minimal adverse events risks that increases compliance and leads to the control achievement over the AR symptoms.