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临床试验/NCT01118936
NCT01118936已完成不适用

Daily Mablet-treatment of Patients With COPD

University of Aarhus2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
EQ-5D

研究概览

简要总结

The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.

The aim of this part of the project is to study the effect of a daily magnesium supplement for COPD-patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD-patients, grade moderate-severe (FEV1 30-80 % of expected. FEV1/FVC < 0,7).

排除标准

  • Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, submission to hospital within the last two years, submission to hospital with exacerbation during the study period, major changes in eating habits within three months prior to study start and during the study period of approx.one year various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.

结局指标

主要结局

EQ-5D

时间窗: Two years

Questionnaire providing a degree of quality of life

次要结局

  • Spirometry(Two years)
  • Diary(Two years)
  • Adverse effects(Two years)
  • 6 minutes walking test - walking distance within 6 minutes (measured in meters)(Two years)
  • 'Medical Research Council Dyspnea Scale' (MRC)(Two years)
  • Endogen NO in expiratory breath and Impulse Oscillometry.(Two years)
  • Blood- and urine samples(Two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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