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Effect of Intravenous Iron (Ferinject®) on Exercise Capacity and Quality of Life of Stable COPD Patients

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Unknown status

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Iron deficiency, 6 Minute-Walking-Test

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of chronic obstructive pulmonary disease according to the current guidelines
Evidence of irreversible airflow obstruction on spirometry (i.e. an increase of less than 200ml and 15% in the post-bronchodilator FEV1)
30% < FEV1 < 80% predicted
Stable COPD medication: no dose changes in COPD medication within last 4 weeks
Age of 40 to 75 years
Body mass index < 30 kg/m2
Iron deficiency:

ferritin <100 ng/mL or ferritin 100-300 ng/mL when TSAT (Transferrin saturation) <20%

Hb between 9.5 and 13.5 g/dL
MMRC (Modified Medical Research Council Scale) 0 to 3
Patient must be able to perform the bicycle exercise test according to investigator

Exclusion Criteria:

Meeting contraindications of iv iron administration
Known active infection
C-reactive protein>20 mg/L
clinically significant bleeding
active malignancy
History of congestive heart failure
BNP (Brain Natriuretic Peptide) ≥ 250 pg/ml
Evidence of myocardial ischemia during Cardiopulmonary Exercise Test (CPET) (i.e. chest pain or signs of ischemia in ECG)
uncontrolled Hypertension
other clinical significant chronic heart disease
Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months
History of peripheral artery occlusive disease
Typical claudication
Anaemia due to reasons other than iron deficiency (e.g.haemoglobinopathy)
History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months
Immunosuppressive therapy or renal dialysis
ALT (Alanine Aminotransferase) or AST (Aspartate Aminotransferase) >3times upper limit of normal
Hemochromatosis
Significant lung diseases other than COPD
pulmonary hypertension (maximum of velocity tricuspid regurgitation > 2,8m/sec)
Exacerbation within prior 4 weeks
> 1 exacerbation within last year
bronchoscopic lung volume reduction (BLVR)
Malignancy within the past 5 years
Autoimmune diseases
Rheumatoid diseases
Chronic renal failure (defined through: eGFR (Estimated Glomerular Filtration Rate) < 60 ml/min)
Active diet
Physical rehabilitation training
Pregnancy, breast feeding
Participation in other therapeutic trial

Sites / Locations

Otto Wagner Spital, Dep. of Respiratory and Critical Care MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion will be administered in patients with COPD

Outcomes

Primary Outcome Measures

Efficacy Endpoint: Increased exercise capacity in 6-Minute-Walking-Test (walking distance in meters [m])

Efficacy Endpoint: Cardiopulmonary Exercise Test (FEV1 [ml] / FVC [% predicted])

Secondary Outcome Measures

Tolerability/Safety Endpoint: Acute COPD exacerbation

Adverse events of iron administration

Full Information

NCT ID

NCT02416778

First Posted

February 10, 2015

Last Updated

September 27, 2016

Sponsor

Georg-Christian Funk

1. Study Identification

Unique Protocol Identification Number

NCT02416778

Brief Title

Effect of Intravenous Iron (Ferinject®) on Exercise Capacity and Quality of Life of Stable COPD Patients

Official Title

Effect of Intravenous Iron (Ferinject®) on Exercise Capacity and Quality of Life of Stable COPD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

February 2017 (Anticipated)

Study Completion Date

February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Georg-Christian Funk

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Disordered iron metabolism characterizes an important determinant of impaired exercise tolerance and work capacity. Iron-deficiency anemia commonly features impaired aerobic capacity caused by decreased oxygen carrying capacity, and has been associated with a negative effect on dyspnea and walking distance. Apart from that, iron deficiency without anemia was shown to affect endurance and energetic efficiency via decreased tissue oxidative capacity. Consequently, depleted iron stores could be capable of causing fatigue, breathlessness and impaired exercise tolerance, which are common features of chronic cardiopulmonary diseases like chronic heart failure (CHF) and COPD (Chronic Obstructive Pulmonary Disease). Indeed, a current surge of interest aimed at potential underlying determinants in CHF and COPD independent of the primarily disordered organ. Recent studies identified iron deficiency without anemia as an independent factor of reduced exercise intolerance in CHF as well as in COPD. Moreover, intravenous iron application significantly improved exercise capacity in CHF patients with iron deficiency in presence as well as in absence of anemia. Comparable to CHF, the daily living of patients with COPD is compromised by impaired exercise tolerance. However, airflow limitation, as the foremost characteristic of COPD shows only weak associations with exercise capacity. In line with that, exercise capacity showed no remarkable improvement in lung transplant recipients, underlining the presence of systemic determinants of limited exercise tolerance like iron deficiency. The investigators showed that iron deficiency is present in 50% of stable COPD patients (unpublished data), which is according to recently published data. The investigators presume that iron deficiency contributes to limited exercise capacity in COPD patients. Thus, the aim of this study is to determine whether iv iron is associated with increases exercise capacity in COPD. Therefore the investigators hypothesize that filling up depleted iron storages will increase exercise capacity, measured by the 6-MWT (Minute Walking Test).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

COPD, Chronic Obstructive Pulmonary Disease, Iron deficiency, 6 Minute-Walking-Test

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion will be administered in patients with COPD

Intervention Type

Drug

Intervention Name(s)

Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion

Primary Outcome Measure Information:

Title

Efficacy Endpoint: Increased exercise capacity in 6-Minute-Walking-Test (walking distance in meters [m])

Time Frame

Study week 12

Title

Efficacy Endpoint: Cardiopulmonary Exercise Test (FEV1 [ml] / FVC [% predicted])

Time Frame

Study week 12

Secondary Outcome Measure Information:

Title

Tolerability/Safety Endpoint: Acute COPD exacerbation

Time Frame

Pre-Screening, Study Day 0, Study week1, study week 4, study week 8 and study week 12

Title

Adverse events of iron administration

Time Frame

Pre-Screening, Study Day 0, Study week1, study week 4, study week 8 and study week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of chronic obstructive pulmonary disease according to the current guidelines Evidence of irreversible airflow obstruction on spirometry (i.e. an increase of less than 200ml and 15% in the post-bronchodilator FEV1) 30% < FEV1 < 80% predicted Stable COPD medication: no dose changes in COPD medication within last 4 weeks Age of 40 to 75 years Body mass index < 30 kg/m2 Iron deficiency: ferritin <100 ng/mL or ferritin 100-300 ng/mL when TSAT (Transferrin saturation) <20% Hb between 9.5 and 13.5 g/dL MMRC (Modified Medical Research Council Scale) 0 to 3 Patient must be able to perform the bicycle exercise test according to investigator Exclusion Criteria: Meeting contraindications of iv iron administration Known active infection C-reactive protein>20 mg/L clinically significant bleeding active malignancy History of congestive heart failure BNP (Brain Natriuretic Peptide) ≥ 250 pg/ml Evidence of myocardial ischemia during Cardiopulmonary Exercise Test (CPET) (i.e. chest pain or signs of ischemia in ECG) uncontrolled Hypertension other clinical significant chronic heart disease Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months History of peripheral artery occlusive disease Typical claudication Anaemia due to reasons other than iron deficiency (e.g.haemoglobinopathy) History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months Immunosuppressive therapy or renal dialysis ALT (Alanine Aminotransferase) or AST (Aspartate Aminotransferase) >3times upper limit of normal Hemochromatosis Significant lung diseases other than COPD pulmonary hypertension (maximum of velocity tricuspid regurgitation > 2,8m/sec) Exacerbation within prior 4 weeks > 1 exacerbation within last year bronchoscopic lung volume reduction (BLVR) Malignancy within the past 5 years Autoimmune diseases Rheumatoid diseases Chronic renal failure (defined through: eGFR (Estimated Glomerular Filtration Rate) < 60 ml/min) Active diet Physical rehabilitation training Pregnancy, breast feeding Participation in other therapeutic trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Georg-Christian Funk, M.D.Ass.Prof

Phone

+43 650 31 00 882

georg-christian.funk@wienkav.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Georg-Christian Funk, M.D.Ass.Prof

Organizational Affiliation

Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine, Pavillon Hermann, Sanatoriumstr. 2, A-1140 Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine

City

Vienna

ZIP/Postal Code

1140

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Georg-Christian Funk, M.D.

Phone

+43 650 3100882

Ext

882

georg-christian.funk@wienkav.at

12. IPD Sharing Statement

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Effect of Intravenous Iron (Ferinject®) on Exercise Capacity and Quality of Life of Stable COPD Patients

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