Iron deficiency in Chronic obstructive pulmonary disease patients (COPD)
Conditions
Interventions
Trade Name: Ferinject 50 mg/ml Solución inyectable y para perfusión
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg
Sponsors
Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To Investigate if intravenous iron (carboxymaltose) treatment in stable COPD and iron deficiency with or without mild anemia improves exercise tolerance.;Secondary Objective: Investigate whether intravenous iron treatment (carboxymaltose) in stable COPD and improve iron deficiency: a) Clinical: 1. Disease symptoms (measured by the CAT and CRQ questionnaires) 2. Daily physical activity (measured by accelerometer and IPAQ questionnaire) b) Basic: 3. Increases levels of hepcidin. 4. Systemic inflammation and oxidative stress response modulate hepcidin.;Primary end point(s): Resistance time cycle ergometer at 75% of the maximum load or Wpico;Timepoint(s) of evaluation of this end point: 4 weeks from treatment administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) CAT and CRQ questionnaires to assess symptoms and quality of life. b) Daily physical activity measured by the accelerometer SenseWear® Pro2 Armband (SWA ; Body Media, Pittsburgh , PA) with a record for 7 days of daily physical activity. c) Venous blood extraction for laboratory tests (routine blood chemistries, including: serum ferritin, transferrin , transferrin saturation, serum iron , blood count hepatograma) , hepcidin for the biomarkers study related to systemic inflammation and route of hepcidin ( IL - 6, CRP ) plus oxidative stress at a blood level.;Timepoint(s) of evaluation of this end point: 4 weeks from treatment administration | — |
Countries
Spain
Contacts
Public ContactServicio de Neumología
Hospital del Mar
Outcome results
None listed