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临床试验/NCT02928744
NCT02928744终止不适用

Evaluation of the Reversibility of the Bronchial Obstruction by Impulse Oscillometry Technique in Chronic Obstructive Pulmonary Disease (COPD): Correlation With Functional Features Measured by Plethysmography and Dyspnoea

Hopital Foch2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
Hopital Foch
入组人数
23
试验地点
2
主要终点
Percentage of obstruction reversibility

研究概览

简要总结

Limitation of expiratory flows is considered as the main determiner of dynamic distension and dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal resistances should allow to better appreciate the functional impact.

This study should also allow to specify the best parameters in respiratory functional explorations useful for the follow-up in COPD and to specify the relevance of functional indications other than the forced expiration volume at 1 second (FEV1) or the functional residual capacity (FRC) to estimate in a more relevant way the clinical improve with the increase of the therapeutic load (increase of posology, association of two bronchodilatators, addition of an anti-inflammatory drug, thus etc…) at already handled patients suffering from a persistent dyspnoea insufficiently relieved.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •COPD with dyspnoea with Medical Research Council scale (MRC) >1,
  • •No exacerbation for 6 weeks
  • •No bronchodilatator short action(share) (ß 2 agonist or ipratropium) within 6 hours before the respiratory evaluation and the test of reversibility.
  • •Patient under current treatment (ß2 long-acting agonist (LABA) or anticholinergic long-acting (LLAMA(LAMA)) or LABA-corticoid association inhaled (CSI), or triples LABA-CSI-LAMA association) stable for at least 4 weeks, and taken for at least the 1 hour the day of the visit
  • •Having given a written consent

排除标准

  • •Patient Under 18
  • •Other respiratory illness
  • •Clinically significant left cardiac failure
  • •Obesity with BMI > 35 kg / m2)
  • •Unable to perform respiratory evaluations
  • •Contraindication to the salbutamol or to the ipratropium bromide or to one of its components
  • •Pregnant or breast-feeding woman
  • •Unable to agree
  • •No social security scheme

研究组 & 干预措施

COPD

Experimental

干预措施: COPD (Other)

结局指标

主要结局

Percentage of obstruction reversibility

时间窗: 2 hours

次要结局

未报告次要终点

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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