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临床试验/NCT05787678
NCT05787678招募中不适用

Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion in the Real Life Severe Asthma Patients

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Number of bronchial inflammatory cells

研究概览

简要总结

Unicentric prospective real life study designed to analyse the efficacy of Dupilumab to reduce bronchial inflammation of asthma measured by inflammatory cell counts obtained in induced sputum and other related characteristics (small airway dysfunction and mucin production) in uncontrolled severe asthma patients in the real life setting without control group

详细描述

After patients signed informed consent, before (visit 1), after 4-5 months (visit 2), and after 12 months (visit 3) Dupilumab treatment began, the following techniques and measurements will be performed or collected: demographic data, blood analyses (eosinophil counts and total IgE), skin prick-test to common aeroallergens (only in the visit 1), asthma control test (ACT), sino-nasal outcome test (SNOT-22), test of adherence to inhalers (TAI), number of severe asthma exacerbations (in the previous year; in the visit 2, in the previous 4 months), oral and inhaled steroid daily doses received, spirometry, exhaled nitric oxide (FeNO), pulmonary volumes, carbon monoxide transference, oscillometry, and induced sputum (inflammatory cell counts and mucin profile [MUC1, MUC2, MUC5AC, MUC5B]). All patients will be performed at visits 1 and 3 in a 3D culture of primary nasal epithelial cells from asthmatic patients the pattern of gene and to identify new soluble biomarkers through quantitative proteomic analysis of culture supernatants.

Also a chest CT scan with expiratory images will be done only in visits 1 and 3.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 -80 years
  • Severe uncontrolled eosinophilic asthma by GINA (Global Initiative for Asthma) criteria
  • Clinical indication of Dupilumab

排除标准

  • Smoking over 10 pack/year
  • Treatment with monoclonal antibodies treatment during the previous three months
  • Refuse to sign informed consent

结局指标

主要结局

Number of bronchial inflammatory cells

时间窗: 1 year

Count of induced sputum leucocytes

次要结局

  • Mucin production from epithelial cells(1 year)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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