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临床试验/NCT07280364
NCT07280364招募中不适用

Metabolomics in the Diagnosis and Treatment of Asthma in Children

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
inflammation biomarkers

研究概览

简要总结

The goal of this observational study is to learn about the metabolomic profile of blood and urine in children 12-17 years with asthma. The main question it aims to answer is:

• Are there metabolites in the blood and urine that are specific for asthma exacerbation? Participants already receive standard therapy as part of their regular medical care for asthma.

详细描述

The study plans to enroll 100 children with a confirmed diagnosis of bronchial asthma of varying severity. Patients will be divided into groups based on disease severity (mild and severe/moderate) and stage (exacerbation/non-exacerbation). A separate group of patients receiving targeted therapy will also be included. All patients will be hospitalized in the pulmonology department. Blood and urine samples will be collected for metabolomic analysis upon admission. Patients not experiencing an exacerbation will not be re-evaluated. For patients experiencing an asthma exacerbation, blood and urine samples will be collected again after 10 days. Throughout the study, patients will receive the usual therapy prescribed by their treating physician. Treatment for exacerbations includes inhaled budesonide and ipratropium bromide/fenoterol via a nebulizer; systemic steroids may be used if indicated. All patients will undergo spirometry upon admission to the department. Patients in the acute stage will undergo spirometry at least twice, including on the 10th day, plus or minus 2 days. All patients complete the Asthma Control Test questionnaire upon admission.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 12 to 17 years old
  • Confirmed diagnosis of asthma
  • Informed voluntary consent to participate in the study

排除标准

  • age under 12 years
  • no established diagnosis of asthma
  • concomitant severe somatic, metabolic, and endocrine diseases
  • patient's withdrawal of informed consent

结局指标

主要结局

inflammation biomarkers

时间窗: baseline and 10 days

Identification of metabolomic changes (inflammation biomarkers) in the blood (aminoacids) and urine (organic acids) of patients with mild, moderate, and severe bronchial asthma associated with asthma exacerbation.

次要结局

  • metabolomic changes(baseline and 10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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