Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Trade Name: Ferinject
Product Name: Ferric Carboxymaltose
Product Code: n/a
Pharmaceutical Form: Solution for injection/infusion
INN or
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with a diagnosis of COPD, with at least mild disease (stage II – IV on GOLD criteria classification, FEV1 15 pack years, where a pack year is the product of [average number of cigarettes smoked per day] and [number of years smoked for] divided by 20) or other definite cause of COPD • Potential to have stable COPD at study initiation • Able (in the Investigators opinion) and willing to comply with all study requirements. • Participant is willing and able to give informed consent for participation in the study. • Male or Female, aged 18 years or above. 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: Exclusion Criteria • Pregnant or breast feeding • Females who are pregnant, lactating, planning pregnancy during the course of the study or of childbearing potential unless using effective contraception for the duration of the study • Patients taking iron supplements (in the last six weeks) or who have had a blood transfusion in the last 6 months • Iron overload, defined as ferritin > 300 microg/L • Hypersensitivity to previous iron infusion • Evidence of bacteraemia • Significant renal or liver disease (as judged by the investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether intravenous iron improves arterial oxygen saturation in patients with COPD at one week.;Secondary Objective: To determine the effects of intravenous iron on oxygenation, exercise capacity, haematinics, time to first exacerbation and quality of life in COPD.;Primary end point(s): To determine whether intravenous iron improves arterial oxygen saturation in patients with COPD at one week. ;Timepoint(s) of evaluation of this end point: 1 week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the effects of intravenous iron on oxygenation, exercise capacity, haematinics, time to first exacerbation and quality of life in COPD. ;Timepoint(s) of evaluation of this end point: Throughout follow-up. | — |
Countries
United Kingdom
Contacts
Public ContactCo-ordinating centre
Oxford Respiratory Trials Unit
Outcome results
None listed