Impact of Iron Deficiency treatment with intravenous ferric carboxymaltose in patients with Chronic Obstructive Pulmonary Disease: an open-label, randomized, 2-arm, no treatment control, parallel study – PULSE study - PULSE Study

António Robalo Nunes0 个研究点目标入组 70 人开始时间: 2018年2月6日最近更新: 2018年5月7日

适应症

试验速览

暂无简介。

•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

•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.

发起方

António Robalo Nunes