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临床试验/NCT03282526
NCT03282526Unknown不适用

Volume Parameters Vs Flow Parameters In Assessment Of Reversibility In Stable Chronic Obstructive Pulmonary Disease Patients

Assiut University0 个研究点目标入组 100 人开始时间: 2017年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Assess the response pattern to inhaled short acting B2 agonist

研究概览

简要总结

  • Assess the differences between flow and volume responses after bronchodilator reversibility testing in patients over different clinical chronic obstructive pulmonary disease stages (GOLD stage I to GOLD stage IV).
  • Study the Correlation between the bronchodilator response and the severity of the disease.

详细描述

chronic obstructive pulmonary disease is a common preventable and treatable disease characterized by persistent airflow limitation that is usually progressive. The diagnosis requires an evidence of obstructive pattern by spirometry measured before and after bronchodilators.

The degree of reversibility of airflow obstruction differs between patients, and does not predict the response to bronchodilator therapy. It can be seen in terms of forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1),or Inspiratory capacity (IC) or residual volume (RV).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients Clinical diagnosis of Chronic Obstructive Pulmonary Disease
  • •Must be able to do pulmonary function test
  • •Age more than 40 years
  • •Stable Chronic Obstructive Pulmonary Disease patients

排除标准

  • •Any patients with a diagnosis of:
  • •Bronchial asthma
  • •Bronchiectasis
  • •Respiratory failure
  • •Decompensated core pulmonale
  • •Chronic Obstructive Pulmonary Disease combined with any other respiratory disease

研究组 & 干预措施

Whole body plethysmography

Experimental

干预措施: Whole body plethysmography (Diagnostic Test)

spirometery

Active Comparator

干预措施: Whole body plethysmography (Diagnostic Test)

结局指标

主要结局

Assess the response pattern to inhaled short acting B2 agonist

时间窗: twice per day one before inhaled short acting B2 agonist and one after 10 minutes from inhaled short acting B2 agonist for average of 2 year

Assess the response pattern to inhaled short acting B2 agonist through measuring flow and volume parameters to define the differences between volumes responders and flow responders

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

Azza Bahaa El-Din Ali Mohamed

Principal Investigator

Assiut University

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