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Full consideration of the pollen exposure effect in clinical trial design for pollen-induced allergic rhinitis

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机构: [1]Capital Med Univ, Beijing Tongren Hosp, Dept Allergy, 17 HouGouhutong, Beijing 100005, Peoples R China [2]Capital Med Univ, Beijing Tongren Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China [3]Beijing Inst Otolaryngol, Beijing Lab Allerg Dis, Beijing, Peoples R China [4]Capital Med Univ, Lab Environm Hlth & Allerg Nasal Dis, Lab Clin Med, Beijing, Peoples R China
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关键词: Pollen-induced allergic rhinitis pollen season allergen-specific immunotherapy biologics trial design pollen exposure

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IntroductionAllergic rhinitis (AR) is global health concern with an increasing prevalence. Among them, pollen-induced AR (PIAR) exhibits more severe and intense symptoms, decreased quality of life, prominent local inflammation, and is thus more challenging to control. Due to the difficulties in disease control, in recent years, an increasing number of treatment methods, including pharmacotherapy, allergen-specific immunotherapy, and newly developed biologics, have focused on PIAR. It has been shown that the pollen exposure has a significant impact on the symptoms of PIAR and the efficacy of intervention. From this perspective, clinical trials for PIAR need to take full account of pollen exposure, especially when assessing efficacy.Areas coveredThis review summarized the effect of pollen exposure on PIAR, including immune responses, symptoms and clinic visits. Current definitions for the pollen season (PS) and the peak pollen season (PPS) are discussed. Based on the previous PIAR-related clinical studies and the available recommendations for clinical trial design, a detailed account of trial protocols which fully considered pollen exposure is provided.Expert opinionPollen exposure has a significant impact on PIAR. With fully considering the pollen exposure in the clinical trial design for PIAR, future protocols for PIAR-related studies may be more objective and better harmonized and, therefore, comparable.

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出版当年[2025]版
大类 | 3 区 医学
小类 | 3 区 免疫学
最新[2025]版
大类 | 3 区 医学
小类 | 3 区 免疫学
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出版当年[2023]版:
Q2 IMMUNOLOGY
最新[2023]版:
Q2 IMMUNOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

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第一作者机构: [1]Capital Med Univ, Beijing Tongren Hosp, Dept Allergy, 17 HouGouhutong, Beijing 100005, Peoples R China [2]Capital Med Univ, Beijing Tongren Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
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通讯机构: [1]Capital Med Univ, Beijing Tongren Hosp, Dept Allergy, 17 HouGouhutong, Beijing 100005, Peoples R China [2]Capital Med Univ, Beijing Tongren Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China [3]Beijing Inst Otolaryngol, Beijing Lab Allerg Dis, Beijing, Peoples R China [4]Capital Med Univ, Lab Environm Hlth & Allerg Nasal Dis, Lab Clin Med, Beijing, Peoples R China
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