Intravenous iron in patients with Chronic Obstructive Pulmonary Disease (COPD)

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2012-002952-17-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-03
• Study Completion: 2017-07-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

•Patients with a diagnosis of COPD, with at least mild disease (stage II – IV on GOLD criteria classification, FEV1 <80% predicted and FEV1/ FVC <70%)
•Significant smoking history (>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
•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 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.<br> ;Timepoint(s) of evaluation of this end point: Throughout follow-up.