Phase II Study Exploring Efficacy and Safety of Iodinated Activated Charcoal in COPD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Exercise Endurance time (EET) on constant workload 75% of maximum capacity
研究概览
简要总结
The purpose of this study s to determine whether treatment with Iodinated Active Charcoal can improve lung function and physical capacity in patients with chronic obstructive lung disorders. The rational for the study is the observation that COPD patients have an increased tissue load of mercury interfering with the function by NeuroEpithelial Endocrine (NEE) cells in the respiratory tract. Mercury binding to these NEE cells leads to an increased smooth muscle tonus and a reduced response to bronchodilator treatment. Initial observational data have shown an improved lung function and improved functional capacity after treatment motivating a larger placebo controlled POC study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and >1 year post-menopausal, or surgically sterile female.
- •45-80 years old.
- •Smokers and ex-smokers, at least 15 pack years.
- •COPD according to GOLD II. FEV% < 70 Post beta2-agonist FEV1 >50 < 80 % of predicted value
- •CO diffusion capacity < 75 %.
- •Active symptomatic COPD with a COPD assessment test (CAT) score >10.
排除标准
- •Alpha-1 antitrypsin deficiency
- •Iodine allergy
- •Abnormal thyroid function
- •Severely reduced kidney function (Cystatin C > 1.5 mg/L.
- •Exacerbation within 4 weeks prior to the study.
- •Use of per oral steroids within 4 weeks prior to the study.
- •Alcohol/drug abuse.
- •Psychiatric disease.
- •Severe cardio-vascular or other severe disease, according to the clinical investigator.
- •Oxygen treatment.
- •Participation in another ongoing clinical trial or participation in drug
研究组 & 干预措施
Iodinated Active Charcoal
Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks)
干预措施: Iodinated Active Charcoal (IodoCarb) (Drug)
non-iodinated activated charcoal
3g non-iodinated activated charcoal is given daily for 8 weeks
干预措施: Iodinated Active Charcoal (IodoCarb) (Drug)
结局指标
主要结局
Exercise Endurance time (EET) on constant workload 75% of maximum capacity
时间窗: At baseline and after 8 weeks intervention
Bicycle work load where the endurance time is recorded. The patients are first doing a maximal workload test determining peak oxygen uptake.
次要结局
- HrQoL(At baseline and after 8 weeks intervention)
- Change in lung function FEV / FVC(At baseline and after 8 weeks intervention)
- Test of thyroid function(At baseline and after 8 weeks intervention)