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<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" article-type="review-article" dtd-version="1.2" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">Russian Journal of Allergy</journal-id><journal-title-group><journal-title xml:lang="en">Russian Journal of Allergy</journal-title><trans-title-group xml:lang="ru"><trans-title>Российский Аллергологический Журнал</trans-title></trans-title-group></journal-title-group><issn publication-format="print">1810-8830</issn><issn publication-format="electronic">2686-682X</issn><publisher><publisher-name xml:lang="en">Publishing House ABV Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">17019</article-id><article-id pub-id-type="doi">10.36691/RJA17019</article-id><article-categories><subj-group subj-group-type="toc-heading" xml:lang="en"><subject>Reviews</subject></subj-group><subj-group subj-group-type="toc-heading" xml:lang="ru"><subject>Научные обзоры</subject></subj-group><subj-group subj-group-type="article-type"><subject>Review Article</subject></subj-group></article-categories><title-group><article-title xml:lang="en">Clinical efficacy and safety of fixed-dose intranasal combination of azelastine hydrochloride and fluticasone propionate for treatment of seasonal allergic rhinitis</article-title><trans-title-group xml:lang="ru"><trans-title>Клиническая эффективность и безопасность фиксированной интраназальной комбинации флутиказона пропионата и азеластина гидрохлорида для лечения сезонного аллергического ринита</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3162-2510</contrib-id><contrib-id contrib-id-type="spin">3363-6170</contrib-id><name-alternatives><name xml:lang="en"><surname>Nenasheva</surname><given-names>Natalya M.</given-names></name><name xml:lang="ru"><surname>Ненашева</surname><given-names>Наталья Михайловна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, Dr. Sci. (Medicine), Professor</p></bio><bio xml:lang="ru"><p>д-р мед. наук, профессор</p></bio><email>1444031@gmail.com</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3508-9602</contrib-id><contrib-id contrib-id-type="spin">2922-9398</contrib-id><name-alternatives><name xml:lang="en"><surname>Sebekina</surname><given-names>Oksana V.</given-names></name><name xml:lang="ru"><surname>Себекина</surname><given-names>Оксана Владимировна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, Cand. Sci. (Medicine), Associate Professor</p></bio><bio xml:lang="ru"><p>канд. мед. наук, доцент</p></bio><email>Sebekin1@mail.ru</email><xref ref-type="aff" rid="aff1"/><xref ref-type="aff" rid="aff2"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2682-8108</contrib-id><contrib-id contrib-id-type="scopus">57210586164</contrib-id><contrib-id contrib-id-type="spin">3363-5507</contrib-id><name-alternatives><name xml:lang="en"><surname>Peredelskaya</surname><given-names>Marina Yu.</given-names></name><name xml:lang="ru"><surname>Передельская</surname><given-names>Марина Юрьевна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, Cand. Sci. (Med.)</p></bio><bio xml:lang="ru"><p>канд. мед. наук</p></bio><email>concy1984@gmail.com</email><xref ref-type="aff" rid="aff1"/><xref ref-type="aff" rid="aff2"/></contrib></contrib-group><aff-alternatives id="aff1"><aff><institution xml:lang="en">Russian Medical Academy of Continuous Professional Education</institution></aff><aff><institution xml:lang="ru">Российская медицинская академия непрерывного профессионального образования</institution></aff></aff-alternatives><aff-alternatives id="aff2"><aff><institution xml:lang="en">City Clinical Hospital No. 24, Moscow</institution></aff><aff><institution xml:lang="ru">Городская клиническая больница № 24, Москва</institution></aff></aff-alternatives><pub-date date-type="preprint" iso-8601-date="2025-05-14" publication-format="electronic"><day>14</day><month>05</month><year>2025</year></pub-date><pub-date date-type="pub" iso-8601-date="2025-06-03" publication-format="electronic"><day>03</day><month>06</month><year>2025</year></pub-date><volume>22</volume><issue>2</issue><issue-title xml:lang="en"/><issue-title xml:lang="ru"/><fpage>207</fpage><lpage>216</lpage><history><date date-type="received" iso-8601-date="2025-04-14"><day>14</day><month>04</month><year>2025</year></date><date date-type="accepted" iso-8601-date="2025-05-12"><day>12</day><month>05</month><year>2025</year></date></history><permissions><copyright-statement xml:lang="en">Copyright ©; 2025, ABV-press</copyright-statement><copyright-statement xml:lang="ru">Copyright ©; 2025, ИД "АБВ-пресс"</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="en">ABV-press</copyright-holder><copyright-holder xml:lang="ru">ИД "АБВ-пресс"</copyright-holder><ali:free_to_read xmlns:ali="http://www.niso.org/schemas/ali/1.0/" start_date="2027-06-03"/><license><ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/">https://eco-vector.com/for_authors.php#07</ali:license_ref></license></permissions><self-uri xlink:href="https://rusalljournal.ru/raj/article/view/17019">https://rusalljournal.ru/raj/article/view/17019</self-uri><abstract xml:lang="en"><p>Allergic rhinitis is a common chronic respiratory disease that affects millions of people worldwide and has a significant impact on their quality of life, productivity, and performance. Achieving control of the symptoms of moderate/severe allergic rhinitis, which often requires the use of several drugs from different pharmacological groups, is particularly challenging.</p> <p>The article considers clinical efficacy and safety of fixed-dose intranasal combination of azelastine hydrochloride and fluticasone propionate for treatment of seasonal allergic rhinitis. The combination of azelastine hydrochloride and fluticasone propionate demonstrates a synergistic effect in improving the symptoms of both early and late allergic reactions and has a pronounced anti-inflammatory effect. Studies show that the use of fixed-dose combination of azelastine hydrochloride and fluticasone propionate significantly improves nasal and ocular symptoms of seasonal allergic rhinitis compared to fluticasone propionate and azelastine hydrochloride monotherapies. The drug acts quickly and provides sustained relief of symptoms which contributes to improved quality of life for the patients.</p> <p>The article provides an overview of the main preclinical, clinical randomized trials and studies in real clinical practice on the efficacy and safety of the fixed-dose intranasal combination, especially in comparison with monotherapies with the drugs included in the combination and placebo. It demonstrates its effectiveness in different populations regardless of race, gender and age, and in long-term use. Azelastine hydrochloride in combination with fluticasone propionate has the most extensive body of evidence of its efficacy, including studies conducted in the Russian patient population. The drug can be used in patients from the age of 12 years with moderate to severe seasonal allergic rhinitis. It is included in all international and Russian guidelines on allergic rhinitis.</p></abstract><trans-abstract xml:lang="ru"><p>Аллергический ринит — распространенное хроническое респираторное заболевание, которое поражает миллионы людей во всем мире и оказывает значительное влияние на их качество жизни, продуктивность и работоспособность. Особую сложность представляет достижение контроля симптомов среднетяжелого/тяжелого аллергического ринита, который зачастую требует применения нескольких препаратов, представителей разных фармакологических групп.</p> <p>В статье рассмотрены клиническая эффективность и безопасность интраназальной фиксированной комбинации флутиказона пропионата и азеластина гидрохлорида для лечения сезонного аллергического ринита. Данная комбинация демонстрирует синергетический эффект в улучшении симптомов как ранней, так и поздней фазы аллергической реакции, обладает выраженным противовоспалительным эффектом. Результаты исследований показывают, что применение интраназальной фиксированной комбинации флутиказона пропионата и азеластина гидрохлорида приводило к значительному улучшению назальных и глазных симптомов сезонного аллергического ринита по сравнению с монотерапией флутиказоном пропионатом и азеластином гидрохлоридом. Препарат обеспечивал быстрое начало действия и устойчивое облегчение симптомов, что способствовало улучшению качества жизни пациентов.</p> <p>Проведен обзор основных результатов доклинических, клинических рандомизированных исследований и исследований в условиях реальной клинической практики по эффективности и безопасности фиксированной интраназальной комбинации, в том числе в сравнении с монопрепаратами, входящими в ее состав, и плацебо. Скорость наступления клинического эффекта фиксированной комбинации флутиказона пропионата и азеластина гидрохлорида в отношении облегчения назальных аллергических симптомов составляет 15 мин, существенно превышая таковую у отдельных компонентов. Препарат демонстрирует эффективность у разных групп населения вне зависимости от расы, пола и возраста, в том числе при длительном применении. Интраназальная фиксированная комбинация флутиказона пропионата и азеластина гидрохлорида имеет самую обширную доказательную базу результатов исследований, в том числе проведенных на российской популяции пациентов. Препарат может применяться у больных с 12 лет для симптоматического лечения сезонного аллергического ринита/риноконъюнктивита средней и тяжелой степеней тяжести. Он включен во все международные и российские рекомендации по аллергическому риниту.</p></trans-abstract><kwd-group xml:lang="en"><kwd>seasonal allergic rhinitis</kwd><kwd>fixed-dose intranasal combination</kwd><kwd>fluticasone propionate</kwd><kwd>azelastine hydrochloride</kwd><kwd>safety</kwd><kwd>quality of life</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>сезонный аллергический ринит</kwd><kwd>интраназальная фиксированная комбинация</kwd><kwd>флутиказона пропионат</kwd><kwd>азеластина гидрохлорид</kwd><kwd>безопасность</kwd><kwd>качество жизни</kwd></kwd-group><funding-group/></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>Аллергический ринит. Федеральные клинические рекомендации. Российская ассоциация аллергологов и клинических иммунологов; Союз педиатров России; Национальная медицинская ассоциация оториноларингологов. 2024. 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