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

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ClinicalTrials.gov Identifier: NCT02416778
Recruitment Status : Unknown
Verified September 2016 by Georg-Christian Funk, Otto Wagner Hospital.
Recruitment status was:  Recruiting
First Posted : April 15, 2015
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Georg-Christian Funk, Otto Wagner Hospital

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 The investigators showed that iron deficiency is present in 50% of stable COPD patients (unpublished data), which is according to recently published data.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).


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Iron (Ferinject®) on Exercise Capacity and Quality of Life of Stable COPD Patients
Study Start Date : February 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion will be administered in patients with COPD
Drug: Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion



Primary Outcome Measures :
  1. Efficacy Endpoint: Increased exercise capacity in 6-Minute-Walking-Test (walking distance in meters [m]) [ Time Frame: Study week 12 ]
  2. Efficacy Endpoint: Cardiopulmonary Exercise Test (FEV1 [ml] / FVC [% predicted]) [ Time Frame: Study week 12 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Adverse events of iron administration [ Time Frame: Pre-Screening, Study Day 0, Study week1, study week 4, study week 8 and study week 12 ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416778


Contacts
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Contact: Georg-Christian Funk, M.D.Ass.Prof +43 650 31 00 882 georg-christian.funk@wienkav.at

Locations
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Austria
Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine Recruiting
Vienna, Austria, 1140
Contact: Georg-Christian Funk, M.D.    +43 650 3100882 ext 882    georg-christian.funk@wienkav.at   
Sponsors and Collaborators
Georg-Christian Funk
Investigators
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Principal Investigator: Georg-Christian Funk, M.D.Ass.Prof Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine, Pavillon Hermann, Sanatoriumstr. 2, A-1140 Vienna

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Responsible Party: Georg-Christian Funk, M.D., Assoc. Prof., Otto Wagner Hospital
ClinicalTrials.gov Identifier: NCT02416778     History of Changes
Other Study ID Numbers: Iron-COPD Pilotstudy
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Georg-Christian Funk, Otto Wagner Hospital:
COPD
Chronic Obstructive Pulmonary Disease
Iron deficiency
6 Minute-Walking-Test
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Iron
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics