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Effect of Post Operative Low Dose Oral Azithromycin in Chronic Rhinosinusitis Patients With Nasal Polyps

2026年8月19日 更新者:Kermina Ehab、Assiut University
Chronic Rhinosinusitis with Nasal Polyps (CRSWNP) is a complex and persistent inflammatory disease of the paranasal sinus mucosa. It is clinically characterized by long-standing sinonasal mucosal inflammation, severe nasal congestion, continuous anterior and posterior rhinorrhea, facial pressure or fullness, and partial or complete loss of olfactory function. Functional Endoscopic Sinus Surgery (FESS) remains the primary surgical procedure of choice for CRSWNP cases that are refractory to conventional medical management. The ultimate goal of FESS is to restore surgical drainage pathways, improve sinus clearance, and re-establish proper sinus ventilation. This surgical intervention creates an anatomical environment optimal for post-operative topical medical therapies. Nevertheless, persistent mucosal inflammation, recalcitrant tissue edema, and post-operative recurrence of polypoid tissue represent major challenges during long-term follow-up. Despite initial surgical success, recurrent nasal polyposis remains a significant clinical challenge following Functional Endoscopic Sinus Surgery (FESS). In cases of recurrence, medical management plays a pivotal role in controlling mucosal inflammation and delaying or preventing re-operation. Diverse pharmacological interventions have been explored to control post-operative recurrence, including standard anti-inflammatory regimens as well as alternative systemic therapies such as some antibiotics, long-term macrolides, and novel biologics targeting specific inflammatory pathways. Macrolides, particularly 15-membered azalides such as Azithromycin, possess significant immunomodulatory and anti-inflammatory properties distinct from their classic antibacterial actions. When administered in low doses over extended periods, Azithromycin actively downregulates pro-inflammatory cytokines, inhibits tissue neutrophil infiltration, decreases goblet cell hypersecretion, and fosters mucosal healing and epithelial restoration.

研究概览

研究类型

介入性

注册 (估计的)

52

阶段

  • 第四阶段

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • • Adult patients of both sexes aged ≥ 18 years.

    • Documented clinical and radiological diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSWNP).
    • Patients with high baseline disease severity scores based on:
  • CT Paranasal Sinuses Staging: High Lund-Mackay CT Score.
  • Symptom Burden Assessment: High SNOT-22 Questionnaire Score. • Patients who comply with scheduled follow-up visits and appointments.

Exclusion Criteria:

  • • Patients aged under 18 years (< 18 years).

    • Presence of unilateral nasal polyps, antrochoanal polyps, granuloma / granulomatous lesions, fungal
    • rhinosinusitis, or suspected benign or malignant sinonasal neoplasms.
    • Development of significant drug-related adverse effects, adverse reactions, or clinical complications during the
    • treatment course.
    • Known hypersensitivity or previous severe allergic reactions to macrolide antibiotics.
    • Baseline prolonged QTc interval, active cardiac arrhythmias, or significant cardiovascular disease.
    • Pre-existing significant impairment of hepatic or renal functions.
    • Pregnant and lactating female patients.
    • Patients who fail to adhere to follow-up visits or refuse to sign the informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器:Study Group
Patients will receive post-operative oral Azithromycin at a dose of 500 mg three times weekly in combination with routine nasal douching (alkaline/saline nasal irrigation three times daily) for a total duration of 12 weeks.
oral Azithromycin at a dose of 500 mg three times weekly
alkaline/saline nasal irrigation three times daily) for a total duration of 12 weeks.
安慰剂比较:Control Group
Patients will be treated with routine nasal douching alone (alkaline/saline nasal irrigation three times daily) for a total duration of 12 weeks.
alkaline/saline nasal irrigation three times daily) for a total duration of 12 weeks.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
recurrence rate of rhinosinusitis after low-dose oral azithromycin
大体时间:12 week
12 week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年8月19日

首先提交符合 QC 标准的

2026年8月19日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • azithromycin in rhinosinusitis

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

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