Impact of Iron Deficiency treatment with intravenous ferric carboxymaltose in patients with Chronic Obstructive Pulmonary Disease

Phase 1

Conditions: Chronic Obstructive Pulmonary Disease and Iron Deficiency
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
MedDRA version: 20.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Registration Number: EUCTR2017-003659-52-PT

Lead Sponsor: António Robalo Nunes

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 70

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:
oFerritin < 100 µg/mL, or
oTransferrin saturation <20%.
4.Able and willing to provide written informed consent and comply with study requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- To assess the prevalence of ID in a cohort of COPD patients.<br>- To assess the changes in hematological parameters of interest.<br>- To assess the safety of ferric carboxymaltose in COPD patients.<br>;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 Outcome Measures