IRON DEFICIENCY IN PATIENTS WITH COPD: IMPACT OF TOPPING WITH IRON CARBOXYMALTOSE. FACE STUDY (ASSESSMENT IN PATIENTS WITH FERINJECT AND IRON DEFICIENCY COPD TO IMPROVE EXERCISE TOLERANCE)

Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)0 个研究点开始时间: 2016年4月20日最近更新: 2016年6月20日

适应症

试验速览

暂无简介。

•-Patients of both genres aged between 45 and 80 years.
•-Clinical stability for at least 8 weeks prior to inclusion in the study.
•- No change for the last 8 weeks in COPD and comorbidities pharmacotherapy treatment since last antibiotics intake and/ or systemic steroids for COPD exacerbation.
•- Patients who have signed the informed consent indicating that they have been informed of all pertinent aspects of the trial.
•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 38
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•-Cardiovascular, neurological, liver, kidney, musculoskeletal alterarions or uncontrolled psychiatric disorders that prevent the exercise.
•- Asthma diagnosis.
•-Obesity, BMI superior than or equal to 30 kg / m2
•- Any digestive, renal or gynecological loss of blood .
•- Chronic home oxygen therapy.
•- Heart failure with fraction ejection below 60%.
•- Active oncologic disease or that have required treatment in the last year.
•-Allergy or hypersensitivity to carboxymaltose iron or to any of the excipients of the study drug.
•- Hemoglobin equal or below 12g / dl in men and 11 g / dl in women.
•- Dose iron replenish superior of 1000 mg (20 ml carboxymaltose iron) in a week
•- Hypersensitivity to parenteral iron. Use of erythropoietin, iron (oral or intravenous -IV-) or transfusion prior month.
•- Chronic liver disease (transaminases three times under the normal value).
•-Pregnant or breast-feeding.
•-Participation in a clinical drug research before 3 months in pre-drug administration.

发起方