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 人开始时间: 2016年8月4日最近更新: 2017年3月13日

适应症

试验速览

暂无简介。

•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
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•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.
•11.Subject is of child-bearing potential or is pregnant or breast feeding.
•12.Contraindication to Ferrous Carboxymaltose (Ferinject):
•a.Hypersensitivity to active substance
•b.Known serious hypersensitivity to other parental iron substance
•c.Anaemia not attributed to iron deficiency (e.g. other microcytic anaemia)
•d.Evidence of iron overload or disturbance in utilisation of iron.

发起方

Royal Brompton and Harefiled NHS Foundation Trust, Royal Brompton Hospital