Iron and Chronic Obstructive Pulmonary Diseaseisorder (COPD) Exercise Trial - ICE-T Trial

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish whether correction of non-anaemic deficiency will improve exercise performance in COPD patients.;Secondary Objective: To establish whether correction of non-anaemic iron deficiency will improvement of Quality of Life scores, muscle oxygen delivery as assessed by near infra-red spectroscopy and the safety an efficacy of ferric carboxymaltose in this patient group.;Primary end point(s): Change in endurance cycle erogmeter time.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - to evaluate the effect of IV FCM versus placebo on MRC/CAT/HADS scores<br>- to evaluate the effect of IV FCM versus placebo on FACIT-F and EQ-5DL-5L score <br>- change of endurance shuttle walk test distance