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Intranasal budesonide for rhinitis during a high airborne pollution period: a randomized controlled trial

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机构: [1]Capital Med Univ, Beijing TongRen Hosp, Dept Allergy, Beijing, Peoples R China [2]Beijing Inst Otolaryngol, Beijing Lab Allerg Dis, Beijing, Peoples R China [3]Beijing Inst Otolaryngol, Beijing Key Lab Nasal Dis, Beijing, Peoples R China [4]Capital Med Univ, Beijing TongRen Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China [5]Hebei Med Univ, Dept Otolaryngol Head & Neck Surg, Hosp 2, Shijiazhuang, Hebei, Peoples R China [6]Cangzhou Ctr Hosp, Dept Otolaryngol Head & Neck Surg, Cangzhou, Hebei, Peoples R China [7]2 Hosp Baoding, Dept Otolaryngol Head & Neck Surg, Baoding, Hebei, Peoples R China [8]Shandong Prov Hosp, Dept Otolaryngol Head & Neck Surg, Jinan, Shandong, Peoples R China [9]2 Peoples Hosp Weifang, Dept Otolaryngol Head & Neck Surg, Weifang, Shandong, Peoples R China [10]Johnson & Johnson Consumer Inc, Ft Washington, MD USA [11]Johnson & Johnson Consumer China Ltd, Shanghai, Peoples R China [12]Johnson & Johnson Consumer Reg Off Asia Pacific, Singapore, Singapore
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关键词: Airborne pollution Air quality index Budesonide Intranasal corticosteroid Intranasal spray Non-allergic rhinitis Perennial allergic rhinitis Pollution Rhinitis Seasonal allergic rhinitis

摘要:
Background Air pollution may induce or reinforce nasal inflammation regardless of allergy status. There is limited direct clinical evidence informing the treatment of airborne pollution-related rhinitis. Objective To assess the effectiveness of intranasal budesonide in adults with self-reported rhinitis symptoms triggered/worsened by airborne pollution. Methods Adults in northern China with self-reported rhinitis symptoms triggered or worsened by airborne pollution were randomized to budesonide 256 mu g/day or placebo for 10 days in pollution season (October 2019 to February 2020). The primary endpoint was the mean change from baseline in 24-h reflective total nasal symptom score (rTNSS) averaged over 10 days. The secondary endpoints were subject-assessed Global Impression of Change (SGIC), mean change from baseline in individual nasal symptom severity, and mean change from baseline in individual non-nasal symptoms of cough and postnasal drip severity. One-sided P < 0.0125 was considered statistically significant. Results After an interruption by COVID-19, an interim analysis showed that the study could be ended for efficacy with n = 206 participants (103/group) since the primary efficacy endpoint demonstrated significant results. The final efficacy results showed that the 10-day-averaged rTNSS change in the budesonide group was greater than with placebo (- 2.20 vs - 1.72, P = 0.0107). Budesonide also significantly improved 10-day-averaged itching/sneezing change (- 0.75 vs - 0.51, P = 0.0009). Results for SGIC and all other individual symptoms did not show significant differences between the two groups. Conclusions Intranasal budesonide 256 mu g once daily improved the total nasal symptoms and itching/sneezing over 10 days in adults with rhinitis triggered/worsened by airborne pollution.

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出版当年[2021]版:
大类 | 4 区 医学
小类 | 4 区 过敏 4 区 免疫学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 过敏 4 区 免疫学
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出版当年[2020]版:
Q3 IMMUNOLOGY Q3 ALLERGY
最新[2023]版:
Q2 ALLERGY Q3 IMMUNOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

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第一作者机构: [1]Capital Med Univ, Beijing TongRen Hosp, Dept Allergy, Beijing, Peoples R China [2]Beijing Inst Otolaryngol, Beijing Lab Allerg Dis, Beijing, Peoples R China [3]Beijing Inst Otolaryngol, Beijing Key Lab Nasal Dis, Beijing, Peoples R China [4]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, Beijing, Peoples R China [2]Beijing Inst Otolaryngol, Beijing Lab Allerg Dis, Beijing, Peoples R China [3]Beijing Inst Otolaryngol, Beijing Key Lab Nasal Dis, Beijing, Peoples R China [4]Capital Med Univ, Beijing TongRen Hosp, Dept Otolaryngol Head & Neck Surg, Beijing, Peoples R China
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