Effects of intravenous iron in COPD

niversity of Oxford (UK)0 个研究点目标入组 48 人开始时间: 2013年6月21日最近更新: 2020年7月6日

试验速览

•Current inclusion criteria as of 28/09/2015:
•1. 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%)
•2. 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
•3. Stable COPD for at least four weeks at study initiation
•5. Able (in the Investigators opinion) and willing to comply with all study requirements.
•5. Participant is willing and able to give informed consent for participation in the study.
•6. Male or Female, aged 18 years or above.
•Previous inclusion criteria:
•1. 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%)
•2. 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
•3. Potential to have stable COPD at study initiation
•4. Pulmonary arterial systolic pressure measurable on echocardiogram
•5. Able (in the Investigators opinion) and willing to comply with all study requirements.
•5. Participant is willing and able to give informed consent for participation in the study.
•6. Male or Female, aged 18 years or above.

•Current exclusion criteria as of 28/09/2015:
•The participant may not participate in the study if ANY of the following apply:
•1. Female participants 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.
•2. Patients taking iron supplements (in the last six weeks) or who have had a blood transfusion in the last 6 months
•3. Iron over-load, defined as ferritin >300mcg/ L
•4. Hypersensitivity to previous iron infusion
•5. Evidence of bacteraemia
•6. Significant renal or liver disease (as judged by the investigator)
•Previous exclusion criteria:
•The participant may not participate in the study if ANY of the following apply:
•1. Arterial oxygen saturations <90%
•2. Unstable heart disease, or other contra-indication to hypoxic exposure
•3. Female participants 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
•4. Oral iron, blood transfusion or altitude exposure within six weeks
•5. Iron over-load, defined as ferritin >300mcg/ L
•6. Hypersensitivity to previous iron infusion
•7. Unable to tolerate exposure to hypoxia
•8. Evidence of bacteraemia, such as fevers or systemic symptoms
•9. Significant renal or liver disease

发起方

niversity of Oxford (UK)