E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Obstructive Pulmonary Disease (COPD) |
Enfermedad Pulmonar Obstructiva Crónica (EPOC) |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Chronic Bronchitis |
Enfermedad Pulmonar Obstructiva Crónica (EPOC), Enfisema, Bronquitis Crónica. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009033 |
E.1.2 | Term | Chronic obstructive pulmonary disease |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To asses if the restoration of the iron levels (with iron carboximaltose, Ferinject®) with respiratory rehabilitation improves the tolerance to effort (measured with the time of resistance in the cardiopulmonary exercise test at 75% of the maximum load or Wpico), in stable patients with COPD and iron deficit (with or without mild anemia) |
Valorar si la restauración de los niveles de hierro (con hierro carboximaltosa, Ferinject®) junto a la rehabilitación respiratoria mejora la tolerancia al esfuerzo (medido mediante el tiempo de resistencia en cicloergómetro al 75% de la carga máxima o Wpico), en pacientes con EPOC estables y déficit de hierro (con o sin anemia leve) |
|
E.2.2 | Secondary objectives of the trial |
To analize possible differences in: a) Symptoms and quality of life (measured by the Control Assessment Test) b) Daily physical activity (measured by accelerometry) |
Analizar posibles diferencias en: a) los síntomas y calidad de vida (medido mediante el Control Assessment Test) b) la actividad física diaria (medida por acelerometría) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adult patients of both genders, with ages between 45 and 80 years 2. CLinical stability of at least 8 weeks previous to the inclusion in the study since the last intake of antibiotics and/or systemic steroids because of COPD exacerbation 3. Unchanged pharmacological treatment during the last 8 weeks of both COPD and cobormilities. 4. Signing of the Informed Consent, indicating that they have been informed of all the aspects of the trial |
1. Pacientes adultos de ambos sexos de edades comprendidas entre los 45 y 80 años. 2. Estabilidad clínica durante al menos 8 semanas previas a la inclusión en el estudio desde la última toma de antibióticos y/o esteroides sistémicos por exacerbación de la EPOC. 3. Tratamiento farmacológico sin cambios durante las últimas 8 semanas tanto de la EPOC como de las comorbilidades. 4. Pacientes que firmen el consentimiento informado indicando que han sido informados de todos los aspectos pertinentes sobre el ensayo |
|
E.4 | Principal exclusion criteria |
1. Cardiovascular, neurological, liver, kidney, musculoskeletal disorders or uncontrolled psychiatric disorders that prevent the practice of exercise. 2. Diagnosis of Asthma. 3. Moderate obesity, BMI greater than or equal to 35 kg / m2 4. Adequately comply with the primary care controls for the search for neoplasms that involve bleeding. 5. Any signs or symptoms of blood loss or evidence of active digestive, renal or gynecological bleeding. 6. Chronic home oxygen therapy. 7. Heart failure with an ejection fraction less than 60%. 8. Active cancer disease or that has required treatment in the last year. 9. Allergy or hypersensitivity to iron carboxymaltose or to any of the excipients of the study drug 10. Hemoglobin equal to or less than 12g / dl in men and 11 g / dl in women. 11. Iron dose to be replaced in a week greater than 1000 mg (20 ml of carboxymaltose iron). 12. Hypersensitivity to parenteral iron. Use of erythropoietin, iron (oral or IV) or transfusion in the previous month. 13. Chronic liver disease (transaminases three times the normal value). 14. Pregnant or lactating women. 15. Participation in any clinical research with drugs within 3 months prior to drug administration. |
1. Alteraciones cardiovasculares, neurológicas, hepáticas, renales, músculo-esqueléticas o trastornos psiquiátricos no controlados que impidan la práctica de ejercicio. 2. Diagnóstico de Asma. 3. Obesidad moderada, IMC mayor o igual a 35 kg/m2 4. Cumplir adecuadamente con los controles de atención primaria para la búsqueda de neoplasias que impliquen sangrados. 5. Cualquier signo o síntoma de pérdida de sangre o evidencia de sangrado activo a nivel digestivo, renal o ginecológico. 6. Oxigenoterapia crónica domiciliaria. 7. Insuficiencia cardíaca con fracción de eyección menor del 60%. 8. Enfermedad oncológica activa o que ha requerido tratamiento en el último año. 9. Alergia o hipersensibilidad al hierro carboximaltosa o a alguno de los excipientes del medicamento en estudio. 10. Hemoglobina igual o inferior a 12g/dl en varones y 11 g/dl en mujeres. 11. Dosis de hierro a reponer en una semana mayor de 1000 mg (20 ml de hierro carboximaltosa). 12. Hipersensibilidad al hierro parenteral. Uso de eritropoyetina, hierro (oral o IV) o transfusión el mes previo. 13. Enfermedad hepática crónica (transaminasas tres veces el valor normal). 14. Mujeres embarazadas o en periodo de lactancia. 15. Participación en alguna investigación clínica con medicamentos dentro de los 3 meses anteriores a la administración del fármaco. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Exercise Tolerance (Endurance Time on cycloergometer at 75% of maximum load or Wpico) |
Tolerancia al ejercicio (Tiempo de resistencia en cicloergómetro al 75% de la carga máxima o Wpico) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Exercice tolerance will be measured 1 month/ 1 week prior to the study, after 4/5 weeks and after 13/14 weeks |
-1 mes/ -1 semana; +4/5 semanas y +13/14 semanas |
|
E.5.2 | Secondary end point(s) |
Quality of life (CAT questionnaire) Daily physical activities (accelerometer) |
Calidad de vida (cuestionario CAT) Actividad física diaria (acelerómetro) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Daily physical activity for one week using accelerometers will be assessed before and after pulmonary 8-weeks of pulmonary rehabilitation in all patients. |
La actividad fiísica diaria se medirá en la semana 4/5 y en la semana 13/14. Los cuestionarios CAT se evaluarán en la semana 4/5 y en la semana 13/14 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of last patient (LVLP) |
última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |