Pulmonary Disease, Chronic ObstructivePhase 4NCT02416778
Effect of Intravenous Iron (Ferinject®) on Exercise Capacity and Quality of Life of Stable COPD Patients
A Phase 4 study testing Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion in people with Pulmonary Disease, Chronic Obstructive, run by Georg-Christian Funk at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2015to Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine
Vienna, State of Vienna, 1140
Georg-Christian Funk, M.D., +43 650 3100882 ext. 882, georg-christian.funk@wienkav.at
About this study
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.
Read more
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).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Iron deficiency, 6 Minute-Walking-Test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / InfusionDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion will be administered in patients with COPD Receives: Drug: Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint: Increased exercise capacity in 6-Minute-Walking-Test (walking distance in meters [m])
Measured: Study week 12
Efficacy Endpoint: Cardiopulmonary Exercise Test (FEV1 [ml] / FVC [% predicted])
Measured: Study week 12
Secondary outcomes (2)
Tolerability/Safety Endpoint: Acute COPD exacerbation
Measured: Pre-Screening, Study Day 0, Study week1, study week 4, study week 8 and study week 12
Adverse events of iron administration
Measured: Pre-Screening, Study Day 0, Study week1, study week 4, study week 8 and study week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georg-Christian Funk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Georg-Christian Funk, Otto Wagner Hospital
- Investigators
- Georg-Christian Funk, M.D.Ass.Prof, Principal investigator, Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine, Pavillon Hermann, Sanatoriumstr. 2, A-1140 Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416778
- Sponsor's protocol ID
- Iron-COPD Pilotstudy
- Status last verified
- Sep 2016
- First submitted
- 10 Feb 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Iron (Ferinject®) on Exercise Capacity and Quality of Life of Stable COPD Patients
- ClinicalTrials.gov ID
- NCT02416778
- Acronym / sponsor ID
- Iron-COPD Pilotstudy
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Iron deficiency, 6 Minute-Walking-Test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Georg-Christian FunkUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / InfusionFerric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion will be administered in patients with COPD |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (31 listed)
- Meeting contraindications of iv iron administration
- Known active infection
- C-reactive protein>20 mg/L
- clinically significant bleeding
- active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion | Drug | Treatment Arm |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg-Christian Funk, M.D.Ass.Prof principal investigator
Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine, Pavillon Hermann, Sanatoriumstr. 2, A-1140 Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion in people with Pulmonary Disease, Chronic Obstructive, run by Georg-Christian Funk at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georg-Christian Funk, M.D.Ass.Prof (+43 650 31 00 882, georg-christian.funk@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Endpoint: Increased exercise capacity in 6-Minute-Walking-Test (walking distance in meters [m]) (time frame: Study week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.