Efficacy and safety of the combination nasal spray olopatadine hydrochloride-mometasone furoate in the treatment of allergic rhinitis

Ludger Klimek, Felix Klimek, Christoph Bergmann, Jan Hagemann, Mandy Cuevas,  Sven Becker MHBA
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Abstract

Introduction

Pharmacotherapy is the main pillar in the treatment of allergic rhinitis. While antihistamines (AH) and intranasal glucocorticosteroids (INCS) have long been part of the therapeutic standard, a pharmacological combination of both active substances in a nasal spray has so far only been implemented and made available in two preparations in Germany. Recently, an intranasal olopatadine hydrochloride-mometasone furoate (Olo-Mom) combination was introduced as a nasal spray for the treatment of seasonal and perennial allergic rhinitis.

Methods

In a literature search, treatment options for allergic rhinitis were analyzed and the available evidence was determined by searching Medline, PubMed, and the national and international study (ClinicalTrials.gov) and guideline registers and the Cochrane Library. Human studies published on the topic in the period up to and including August 2023 were taken into account.

Results

Based on the international literature and previous experience, the results are summarized and recommendations are given. The drugs used in the pharmacotherapy of AR primarily include INCS, intranasal and oral AH, leukotriene antagonists, intranasal cromoglicic acid preparations, intranasal and oral vasoconstrictors, and nasal rinses. For patients with intermittent and persistent allergic rhinitis, INCS are the first-line therapy, but in many patients they do not work sufficiently or quickly enough. The fixed combination Olo-Mom nasal spray showed significant improvements in the Reflective Total Nasal Symptom Score (rTNSS) in two phase II clinical trials with twice-daily and once-daily administration. In phase III studies, Olo-Mom nasal spray administered twice daily showed significant improvements in rTNSS compared to placebo, olopatadine monotherapy, and mometasone monotherapy.

Conclusion

In summary, AH and INCS will remain the main groups of active ingredients in the treatment of allergic rhinitis in the future. In combination preparations such as the new combination nasal spray olopatadine hydrochloride-mometasone furoate, they are highly effective and safe, thus opening up new perspectives, especially for patients with moderate and severe allergic rhinitis from the age of 12 years.

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盐酸奥洛他定-糠酸莫米松复方鼻喷雾剂治疗过敏性鼻炎的疗效和安全性
导言药物疗法是治疗过敏性鼻炎的主要支柱。长期以来,抗组胺药(AH)和鼻内糖皮质激素(INCS)一直是治疗标准的一部分,但将这两种活性物质结合在鼻腔喷雾剂中的药理组合迄今为止只在德国实施过,并有两种制剂可供选择。方法在文献检索中,通过检索 Medline、PubMed、国内和国际研究(ClinicalTrials.gov)和指南登记册以及 Cochrane 图书馆,对过敏性鼻炎的治疗方案进行了分析,并确定了可用证据。结果根据国际文献和以往的经验,对结果进行了总结并给出了建议。用于 AR 药物治疗的药物主要包括 INCS、鼻内和口服 AH、白三烯拮抗剂、鼻内色甘酸制剂、鼻内和口服血管收缩剂以及鼻腔冲洗剂。对于间歇性和持续性过敏性鼻炎患者来说,INCS 是一线疗法,但对许多患者来说,INCS 的作用不够充分或不够迅速。固定复方 Olo-Mom 鼻腔喷雾剂在两项 II 期临床试验中显示,通过每天两次和每天一次的用药,鼻部症状总评分(rTNSS)有明显改善。在 III 期研究中,与安慰剂、奥洛帕他定单药治疗和莫美他松单药治疗相比,每天给药两次的 Olo-Mom 鼻腔喷雾剂显示 rTNSS 有明显改善。在盐酸奥洛他定-糠酸莫米松新型复方鼻喷雾剂等复方制剂中,它们具有高效、安全的特点,从而开辟了新的前景,尤其适用于 12 岁以上的中度和重度过敏性鼻炎患者。
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来源期刊
Allergo Journal International
Allergo Journal International Medicine-Immunology and Allergy
CiteScore
4.60
自引率
0.00%
发文量
31
期刊介绍: Allergo Journal International is the official Journal of the German Society for Applied Allergology (AeDA) and the Austrian Society for Allergology and Immunology (ÖGAI). The journal is a forum for the communication and exchange of ideas concerning the various aspects of allergy (including related fields such as clinical immunology and environmental medicine) and promotes German allergy research in an international context. The aim of Allergo Journal International is to provide state of the art information for all medical and scientific disciplines that deal with allergic, immunological and environmental diseases. Allergo Journal International publishes original articles, reviews, short communications, case reports, and letters to the editor. The articles cover topics such as allergic, immunological and environmental diseases, the latest developments in diagnosis and therapy as well as current research work concerning antigens and allergens and aspects related to occupational and environmental medicine. In addition, it publishes clinical guidelines and position papers approved by expert panels of the German, Austrian and Swiss Allergy Societies. All submissions are reviewed in single-blind fashion by at least two reviewers. Originally, the journal started as a German journal called Allergo Journal back in 1992. Throughout the years, English articles amounted to a considerable portion in Allergo Journal. This was one of the reasons to extract the scientific content and publish it in a separate journal. Hence, Allergo Journal International was born and now is the international continuation of the original German journal. Nowadays, all original content is published in Allergo Journal International first. Later, selected manuscripts will be translated and published in German and included in Allergo Journal.
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