跳至主要内容
临床试验/CTRI/2021/09/036457
CTRI/2021/09/036457尚未招募不适用

Evaluation of small-airway dysfunction in chronic obstructive pulmonary disease

Amit Kiran Rath1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年9月15日

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
prevalence of small airway dysfunction in COPD groups

研究概览

简要总结

This is a cross-sectional study to observe the prevalence of small airway dysfunction in different COPD groups. These groups are per the Global initiative for chronic obstructive lung disease (GOLD) guideline. The COPD groups are classified based on the severity of symptoms and history of exacerbation in the past 1 year. This study will help to calculate the burden of small airway dysfunction in different COPD groups in patients from India. It will also help how the current recommended treatment by GOLD changes the small airway dysfunction measured in terms of forced oscillation technique, spirometry, and Body plethysmography and whether this small airway dysfunction is related to the quality of life measured in terms of COPD ASSESSMENT TEST(CAT) scoring.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of COPD as per 2021 GOLD (Global initiatives for Obstructive Lung Disease) guidelines (Post BDR FEV1/FVC < 0.7 and β2 agonists reversibility of less than 12% or 200ml)(36).

排除标准

  • –Not able to perform an acceptable test –Hemodynamically compromised –Exacerbation of COPD within past 4 weeks –Other lung diseases like TB, asthma, interstitial lung diseases, structural lung diseases, e.g., bronchiectasis, lung cancer, respiratory infection in 2 weeks, history of pulmonary surgery –Pregnant women.

结局指标

主要结局

prevalence of small airway dysfunction in COPD groups

时间窗: at the point of interaction

次要结局

  • monitoring lung function parameters after optimised treatment(3 months and 1 year)
  • quality of life as CAT score(with oscillatory technique parameters, like R5, X5, EFL, R5-19)

研究者

发起方
Amit Kiran Rath
申办方类型
Other [self]

研究点 (1)

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