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
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 The investigators showed that iron deficiency is present in 50% of stable COPD patients (unpublished data), which is according to recently published data.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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Efficacy Endpoint: Increased exercise capacity in 6-Minute-Walking-Test (walking distance in meters [m]) [ Time Frame: Study week 12 ]
- Efficacy Endpoint: Cardiopulmonary Exercise Test (FEV1 [ml] / FVC [% predicted]) [ Time Frame: Study week 12 ]
- 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 ]
- Adverse events of iron administration [ Time Frame: Pre-Screening, Study Day 0, Study week1, study week 4, study week 8 and study week 12 ]
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
|Contact: Georg-Christian Funk, M.D.Ass.Prof||+43 650 31 00 email@example.com|
|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 firstname.lastname@example.org|
|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|