Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 19.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Ferinject
Product Name: Ferinject
Product Code: B03AC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Iron as ferric carboxymaltose
Concentration unit: mg milligram(s)
Co
Sponsors
Royal Brompton and Harefiled NHS Foundation Trust, Royal Brompton Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically stable patients (>18 years old), GOLD II-IV COPD FEV1:FVC 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
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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - to evaluate the effect of IV FCM versus placebo on MRC/CAT/HADS scores - to evaluate the effect of IV FCM versus placebo on FACIT-F and EQ-5DL-5L score - change of endurance shuttle walk test distance | — |
Countries
United Kingdom
Contacts
Public ContactIra Jakupovic
Royal Brompton and Harefield NHS Foundation Trust
Outcome results
None listed