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临床试验/NCT01109160
NCT01109160已完成4 期

A Prospective, Open-label Study of Azithromycin for Lymphocytic Bronchiolitis/Bronchitis After Lung Transplantation

KU Leuven1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
KU Leuven
入组人数
15
试验地点
1
主要终点
Histology on bronchial and/or transbronchial biopsies

研究概览

简要总结

This study investigates the role of azithromycin treatment for lymphocytic bronchitis/bronchiolitis after lung transplantation.

详细描述

Lymphocytic bronchitis/bronchiolitis is one of the major risk factors for development of chronic rejection/BOS after lung transplantation. There is currently no established treatment available for this condition. There is now mounting evidence that IL-17 producing lymphocytes (TH17) not only participate in chronic allograft rejection/BOS, but are also present within the airway wall during lymphocytic bronchiolitis and that IL-17 mRNA-levels in bronchoalveolar lavage fluid of these patients are upregulated. As such, TH17 may account for the increased BAL neutrophilia seen in these patients, as IL-17 may be responsible for driving IL-8 secretion (a neutrophil-attracting chemokine) from various cell types in the airways. Since azithromycin has previously been shown to reduce both IL-17 induced IL-8 production by human airway smooth muscle cells 'in vitro' and bronchoalveolar IL-8/neutrophil levels in LTx recipients with established BOS, we believe that azithromycin has great potential for treating lymphocytic bronchi(oli)tis by attenuating this TH17/IL-17/IL-8-mediated airway inflammation, possibly even halting the subsequent development of chronic rejection/BOS after lung transplantation. In this study, histologic, spirometric, bronchoalveolar an radiologic features will be investigated in patients treated with confirmed lymphocytic bronchitis/bronchiolitis treated with azithromycin.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent
  • Adult (age at least 18 years old at moment of transplantation)
  • Able to take oral medication
  • Histologic diagnosis of lymphocytic bronchiolitis or bronchitis ('grade B') without concurrent acute cellular allograft rejection 'grade A' ≥2

排除标准

  • Severe suture problems (e.g. airway stenosis) requiring lasering or stenting

研究组 & 干预措施

Azithromycin

Experimental

Add-on of study-drug (azithromycin) to 'standard of care': 250 mg daily for 5 days, followed by 250 mg every other day until the end of the study-period (6 months treatment).

干预措施: Azithromycin Dihydrate (Drug)

结局指标

主要结局

Histology on bronchial and/or transbronchial biopsies

时间窗: after 3 months of treatment

Evolution of lymphocytic airway inflammation after 3 months of treatment

Pulmonary function (FEV1)

时间窗: after 3 months of treatment

Evolution of FEV1 after 3 months of treatment

Bronchoalveolar cellularity and protein levels (IL-8, IL-17)

时间窗: after 3 months of treatment

Evolution of bronchoalveolar cellularity and protein levels (IL-8, IL-17) after 3 months of treatment

Radiologic features

时间窗: after 3 months of treatment

Evolution of radiologic features (e.g. tree-in-bud, consolidation, bronchiectasis, air trapping, etc.) on chest X-ray or HRCT after 3 months of treatment

次要结局

  • Pulmonary function (FEV1)(after 6 months of treatment)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

GM. Verleden

Medical Director Leuven Lung Transplant Programme

KU Leuven

研究点 (1)

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