EUCTR2016-000829-39-GB
进行中（未招募）
1 期
Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial - ICE-T
Royal Brompton and Harefiled NHS Foundation Trust, Royal Brompton Hospital0 个研究点目标入组 40 人2016年8月4日
适应症Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 19.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Chronic Obstructive Pulmonary Disease (COPD)
- 发起方
- Royal Brompton and Harefiled NHS Foundation Trust, Royal Brompton Hospital
- 入组人数
- 40
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Clinically stable patients (\>18 years old), GOLD II\-IV COPD FEV1:FVC \< 0\.70
- •2\.Non\-anaemic: males haemoglobin (Hb) \= 130g/L, and females \= 120g/L
- •3\.Iron deficiency, defined as:
- •a.Serum Ferritin \< 100 µg/ml
- •b.Serum Ferritin 100\-299 µg/ml with Transferrin saturation (TSAT) \< 16%
- •c.Soluble transferring receptor \> 28\.1nmol/L
- •4\.No history of lower respiratory tract infection or exacerbation of COPD in the last 6 weeks
- •5\.No participation in Pulmonary Rehabilitation (PR) for at least 3 months prior to initial assessment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
排除标准
- •1\.Polycythemia defined as Hb \> 170g/L and haematocrit \> 0\.6 in males and Hb \> 150g/L and haematocrit \> 0\.56 in females.
- •2\.Significant co\-morbidity contributing to reduced exercise tolerance
- •3\.Congestive cardiac failure defined as LVEF \< 45% or plasma B\-type natriuretic peptide (BNP) \> 100pg/ml.
- •4\.Oral iron therapy at doses \> 100mg/day in the previous week prior to randomisation.
- •5\.Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of normal range.
- •6\.Anaemia (WHO \[31]) defined as Hb \< 130g/L in males \> 15 yrs old and Hb \< 120g/L in non\-pregnant females.
- •7\.Current malignancy or haematological disorders.
- •8\.Currently receiving systemic chemotherapy and/or radiotherapy.
- •9\.Renal dialysis (previous, current or planned).
- •10\.Unstable angina.
结局指标
主要结局
未指定
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