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临床试验/NCT05097638
NCT05097638已完成不适用

Lung Health After Tuberculosis: Clinical and Functional Assessment in Post Pulmonary Tuberculosis Egyptian Patients.

Assiut University1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2018年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
210
试验地点
1
主要终点
Post tuberculosis lung functional impairment

研究概览

简要总结

Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment

详细描述

Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment which may influence their quality of life. However, the pattern and nature of post-tuberculosis lung impairment is still not identified. Thus, the aim of this study was to determine the type and degree of lung physiology changes in previously treated tuberculous patients which latter may affect their quality of life; thus helping clinicians for early diagnosis of lung impairment, especially in tuberculous endemic areas.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient completed an outpatient course of standard first line anti-tuberculosis therapy and declared as cured

排除标准

  • Smoker (to avoid spirometry biases).
  • Extrapulmonary tuberculosis cases
  • Multidrug resistant tuberculosis
  • known contraindications to spirometry testing
  • Individuals with chest wall deformities or neuromuscular diseases
  • Patients who failed to achieve acceptability and reproducibility criteria of the spirometry test
  • Defaulter cases or irregular treatment,
  • known coexisting chronic lung disease as history of asthma or interstitial lung diseases
  • A history of illicit drug use
  • Patients with comorbidities: renal and hepatic insufficiency, heart diseases and metabolic disorders.

结局指标

主要结局

Post tuberculosis lung functional impairment

时间窗: 6 months

spirometry abnormality either: restrictive, obstructive, or mixed

Grading of obstruction function:

时间窗: 6 months

grading according to GOLD : mild , moderate , severe , very severe

post tuberculosis persistent clinical symptoms

时间窗: 6 months

either cough , sputum , breathlessness, hemoptysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nermeen Aly Mahmoud Abdel Aleem

Lecture in Chest and Tuberculosis Department, Faculty of Medicine

Assiut University

研究点 (1)

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