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临床试验/NCT06029543
NCT06029543尚未招募不适用

Permian Health Women's Lung Health Study

Permian Health Lung Institute1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2023年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
350
试验地点
1
主要终点
Prevalence of lung function Impairment as measured by spirometry

研究概览

简要总结

The goal of this cross-sectional observational study is to estimate the prevalence of lung function impairment as measured by spirometry in a population of Gambian women aged 15 and older. The main question[s] it aims to answer are:

  • What is the prevalence of lung function impairment in Gambian women
  • What is the prevalence of eosinophilic inflammation in Gambian women

Consenting participants will undergo

  • Spirometry
  • Fractional exhaled nitric oxide (FENO) testing
  • α1-antitrypsin testing in patients with lung function impairment as assessed by spirometry

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Prevalence of lung function Impairment as measured by spirometry

时间窗: Through study completion, an average of 1 year

Certified technicians will perform Spirometry testing to measure lung function parameters such as FEV1, FVC, and FEV1/FVC ratio. Results will be interpreted by two Pulmonologists using GLI reference equations and z-scores. Bronchodilator reversibility is defined as an improvement of over 10% in FEV1 after albuterol sulfate administration. Lung function impairment will be assessed based on z-scores, with normal lung function being z-scores greater than -1.645, mild impairment between -1.65 and -2.5, moderate impairment between -2.51 and -4, and severe impairment below -4.1.

次要结局

  • Prevalence of Type II (Eosinophilic) inflammation in Gambian Women(Through study completion, an average of 1 year)

研究者

发起方
Permian Health Lung Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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