Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II single centre, double blind, placebo-controlled, randomised trial aims to test the hypothesis that intravenous iron improves exercise performance in Chronic Obstructive Pulmonary Disease (COPD) as measured by constant rate cycle ergometry.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Treatments: Ferric Compounds; Iron

Criteria

Inclusion Criteria:

1. Clinically stable patients (>18 years old), Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV COPD Forced Expiratory Volume in 1 second (FEV1):Forced Vital capacity (FVC) < 0.70

2. Non-anaemic: males haemoglobin (Hb) ≥ 130g/L, and females ≥ 120g/L

3. Iron deficiency, defined as:

1. Serum Ferritin < 100 µg/ml

2. Serum Ferritin 100-299 µg/ml with Transferrin saturation (TSAT) < 16%

3. 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.

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 Left Ventricular Ejection Fraction (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):

1. Hypersensitivity to active substance

2. Known serious hypersensitivity to other parental iron substance

3. Anaemia not attributed to iron deficiency (e.g. other microcytic anaemia)

4. Evidence of iron overload or disturbance in utilisation of iron.