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Expression of TSLP Isoforms in Asthma

2026年8月24日 更新者：Medical University of Warsaw

TSLP and Its Isoforms (Short and Long Form TSLP) in Different Asthma Phenotypes

Asthma is a heterogeneous disease characterized by chronic airway inflammation, leading to variable airflow obstruction, bronchial hyperresponsiveness, excessive mucus secretion, and, consequently, structural airway remodeling. Asthma is defined by the presence of symptoms such as wheezing, dyspnea, chest tightness, and cough, with variable intensity and frequency.

Thymic stromal lymphopoietin (TSLP) is a cytokine produced primarily by epithelial cells in the lungs. Two distinct isoforms of TSLP have been identified: a long form (lfTSLP) and a short form (sfTSLP). The long isoform is induced during inflammatory conditions and promotes a T2-dependent immune response. In contrast, the short isoform is believed to exert homeostatic and anti-inflammatory functions and exhibits antimicrobial properties.

Studies have demonstrated an association between elevated serum and airway TSLP levels and increased disease severity, as well as reduced spirometric parameters. However, the literature contains limited data regarding the expression of TSLP isoforms across different asthma phenotypes and their relationship with the degree of disease control.

The goal of this study is:

  1. To assess the expression of TSLP protein and TSLP mRNA, including its isoforms (sfTSLP and lfTSLP), in serum and in airway-derived samples (nasal epithelial cells),
  2. To compare these levels among patients with different asthma phenotypes (allergic and non-allergic asthma; eosinophilic, neutrophilic, and paucigranulocytic asthma; early-onset and late-onset asthma; obesity-associated asthma; cough-variant asthma), as well as between patients with asthma and healthy controls.
  3. To analyze the correlations between the expression of TSLP isoforms (sfTSLP and lfTSLP) and asthma severity, level of disease control (as measured by the Asthma Control Questionnaire [ACQ]), pulmonary function parameters, blood eosinophil count and other clinical parameters.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

70

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 波兰
    • Warsaw
      • Warsaw、Warsaw、波兰、02-097
        • 招聘中
        • Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw, Warsaw, Poland,
        • 接触：
        • 首席研究员：
          • Marta Dąbrowska, MD, PhD, Associate Professor
        • 副研究员：
          • Izabela Orzołek, MD

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

是的

取样方法

非概率样本

研究人群

Patients with severe asthma, with different asthma phenotypes (allergic and non-allergic asthma; eosinophilic, neutrophilic, and paucigranulocytic asthma; early-onset and late-onset asthma; obesity-associated asthma; cough-variant asthma).

描述

  1. Inclusion criteria

    • age > 18 years, without the upper age limit,
    • asthma (diagnosis in accordance with the GINA 2023 guidelines),

  2. Exclusion criteria

    • other respiratory diseases (e.g., chronic obstructive pulmonary disease [COPD]);
    • active cigarette smoking or a smoking history of >10 pack-years;
    • active malignancy;
    • active pulmonary tuberculosis or active respiratory tract infection;
    • use of antibiotics within 4 weeks prior to study enrollment;
    • current long-term home oxygen therapy (>15 hours per day);
    • current treatment with monoclonal antibody therapies (e.g., omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab, or other biologics);
    • pregnancy.

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

队列和干预

团体/队列
干预/治疗
Study group consists of patients with severe asthma (diagnosed according to GINA guidelines)
  1. Inclusion criteria Adults aged 18 years, without the upper age limit, diagnosed with asthma established in accordance with the GINA 2023 guidelines.
  2. Exclusion criteria Presence of other concomitant respiratory diseases (e.g., chronic obstructive pulmonary disease [COPD]); Current use of systemic glucocorticoids or immunosuppressive therapy, or use within 4 weeks prior to study enrollment; Active cigarette smoking or a smoking history of >10 pack-years; Active malignancy; Active pulmonary tuberculosis or active respiratory tract infection; Use of antibiotics within 4 weeks prior to study enrollment; Current long-term home oxygen therapy (>15 hours per day); Current treatment with monoclonal antibody therapies (e.g., omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab, or other biologics); Pregnancy.
诊断测试：No Intervention: Observational Cohort
This study is designed as a cross-sectional, observational investigation. No therapeutic or diagnostic interventions beyond routine clinical care will be introduced as part of the study. All procedures performed are limited to standard, minimally invasive sample collection and data acquisition for research purposes. Clinical management of participants will remain unchanged and will be conducted entirely at the discretion of the treating physicians. Participation in the study will not influence treatment decisions or patient care.
Control group
  1. Inclusion criteria Age above 18 years old and without the upper age limit. Negative medical history for asthma and allergic diseases.
  2. Exclusion criteria Diagnosed asthma or any other respiratory disease; Atopic dermatitis, allergic rhinitis, or other allergic diseases; Autoimmune diseases; All other exclusion criteria identical to those applied to the asthma patient group.
诊断测试：No Intervention: Observational Cohort
This study is designed as a cross-sectional, observational investigation. No therapeutic or diagnostic interventions beyond routine clinical care will be introduced as part of the study. All procedures performed are limited to standard, minimally invasive sample collection and data acquisition for research purposes. Clinical management of participants will remain unchanged and will be conducted entirely at the discretion of the treating physicians. Participation in the study will not influence treatment decisions or patient care.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
TSLP mRNA expression, including the sfTSLP and lfTSLP isoforms in nasal epithelial cells and TSLP protein expression in blood and nasal epithelial cells
大体时间：This is cross-sectional studies; blood and nasal epithelial cells (nasal swab) will be taken from each study participant at one study point - through study completion, an average of 2 years

The primary endpoint of the study is the quantitative assessment of TSLP protein expression and TSLP mRNA expression, including the sfTSLP and lfTSLP isoforms, in biological material obtained from serum and nasal epithelial cells.

Peripheral venous blood samples will be collected and centrifuged to obtain serum, which will be aliquoted and stored at -80°C until analysis. Nasal epithelial cells will be collected using sterile cytology brushes. All biological samples will be processed promptly and stored under appropriate conditions prior to laboratory analysis.

TSLP protein concentrations will be measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits in accordance with the manufacturer's instructions. Measurements will be performed in duplicate, and optical density will be determined using a microplate reader. Concent
This is cross-sectional studies; blood and nasal epithelial cells (nasal swab) will be taken from each study participant at one study point - through study completion, an average of 2 years

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。

赞助

Medical University of Warsaw

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 (实际的)

2024年4月30日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2026年1月23日

首先提交符合 QC 标准的

2026年8月24日

首次发布 (实际的)

2026年8月26日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Medical University of Warsaw
  • 31/M/MB/N/24 (其他赠款/资助编号：Young Scientist Grant, Medical University of Warsaw)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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