Chronic Obstructive Pulmonary Disease and Iron Deficiency MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Ferinject
Product Name: Ferinject
Product Code: ATC-Code B03AC
Pharmaceutical Form: Solution for infusion
Sponsors
António Robalo Nunes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female. 2. COPD diagnosis, according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines from 2017. 3. Iron Deficiency (ID) diagnosis according to the following criteria: o Ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Known sensitivity to ferric carboxymaltose. 2. Participating in a pulmonary rehabilitation program. 3. Previously treated for Iron Deficiency (ID), either with oral or intravenous iron, in the past 3 months. 4. Any underlying condition that causes hemorrhage during the patient’s participation in the trial. 5. Moderate to severe hepatic impairment (Class B or greater), as determined by Child-Pugh classification; hemodialysis-dependent chronic kidney disease; or history of hepatic or renal conditions that may suggest being contraindications for ferric carboxymaltose treatment after a benefit/risk assessment. 6. Under treatment which is contraindicated with ferric carboxymaltose or intravenous therapies, i.e. oral iron therapy. 7. Woman of childbearing potential (WOCBP), defined as “fertile, following menarche and until becoming post-menopausal (i.e., no menses for 12 months without an alternative medical cause)”; unless permanently sterile. 8. COPD exacerbations in the last 30 days. 9. Active or chronic infection. 10. Clinically significant laboratory results or any other significant condition that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the impact of ID treatment with intravenous ferric carboxymaltose in patients with COPD, on the 6MWT, after 8 weeks post baseline visit.;Secondary Objective: - To explore the efficacy of ferric carboxymaltose in COPD patients with underlying ID in other clinical assessments of interest. - To assess the prevalence of ID in a cohort of COPD patients. - To assess the changes in hematological parameters of interest. - To assess the safety of ferric carboxymaltose in COPD patients. ;Primary end point(s): -25-meters increase in 6MWT [time-frame: baseline versus 8 weeks].;Timepoint(s) of evaluation of this end point: 8 weeks post-baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Relative and absolute change in 6MWT distance [time-frame: baseline versus 8 weeks]. - Relative and absolute change in peripherical oxygen saturation during 6MWT. - Relative and absolute change in Borg scale during 6MWT. - 2-point improvement in COPD assessment test (CAT) [time-frame: baseline versus 8 weeks]. - Relative and absolute change in CAT scores [time-frame: baseline versus 8 weeks]. - Relative and absolute change in Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC ratio, and Forced Expiratory Flow at 25-75% of FVC (FEF25-75%) [time-frame: baseline versus 8 weeks]. - 10% increase in FEV1 [time-frame: baseline versus 8 weeks]. - Proportion of patient achieving ID correction [time-frame: baseline versus 8 weeks]. - Absolute and relative change in other relevant laboratory assessments [time-frame: baseline versus 8 weeks]. - Use of rescue medication for COPD exacerbations. - Rate and severity of COPD exacerbations. - Patient Global Impression of Change (PGIC). - Clinician Global Impression of Change (CGIC). - Incidence of Adverse Events (AE).;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Countries
Portugal
Contacts
Public ContactSilvia Sirgado
Scientific Toolbox Consulting
Outcome results
None listed