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临床试验/EUCTR2011-005544-10-GB
EUCTR2011-005544-10-GB进行中(未招募)1 期

Improving Inhaler Treatment and Small Airways Assessment in Chronic Obstructive Pulmonary Disease - Drug Lung Deposition In COPD

Imperial College London0 个研究点目标入组 65 人开始时间: 2012年3月29日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
65

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • COPD patients, either male or female, over the age of 40 with a clincal diagnosis of COPD with airflow obstruction (FEV1/FVC<0.7) and post-bronchodilator FEV1>50% predicted, gas trapping (on lung volume testing), and decreased carbon monoxide transfer factor.
  • Healthy subjects will be non-smokers (or ex-smokers stopped 5 years ago), will have no respiratory disease, normal spirometry and be age-matched to the COPD patients.
  • Asthmatic subjects, either male or female, over the age of 18 with a clincal diagnosis of Asthma with airflow obstruction (FEV1/FVC<0.7).
  • Capable of giving informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 43
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • 1) Oral corticosteroids taken within last month.
  • 2)Current involvement (or involvement in the last 4 weeks)in clinical trials assessing investigational medicinal products.
  • 3)Previous adverse reaction to short or long acting ß2 agonist.
  • 4) Any subject with a contraindication to taking inhaled beta-2 adrenoceptor agonists (especially salbutamol) as listed in the British National Formulary will not be entered into this study.
  • 5) Those who have experienced an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit).
  • 6) Pregnant or breast-feeding women.
  • 7) Subjects unable to give Informed Consent.

研究者

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