EUCTR2012-002952-17-GB进行中(未招募)1 期
Effects of intravenous iron on hypoxic pulmonary responses in COPD - Intravenous iron in COPD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 48
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
- •Patients with a diagnosis of COPD, with at least mild disease (stage II – IV on GOLD criteria classification, FEV1 <80% predicted and FEV1/ FVC <70%)
- •Significant smoking history (>15 pack years, where a pack year is the product of [average number of cigarettes smoked per day] and [number of years smoked for] divided by 20) or other definite cause of COPD
- •Potential to have stable COPD at study initiation
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Exclusion Criteria
- •Pregnant or breast feeding
- •Females who are pregnant, lactating, planning pregnancy during the course of the study or of childbearing potential unless using effective contraception for the duration of the study
- •Patients taking iron supplements (in the last six weeks) or who have had a blood transfusion in the last 6 months
- •Iron overload, defined as ferritin > 300 microg/L
- •Hypersensitivity to previous iron infusion
- •Evidence of bacteraemia
- •Significant renal or liver disease (as judged by the investigator)
研究者
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