E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ambulatory patients, men and women, with well-established diagnosis of idiopathic pulmonary fibrosis. |
Pacientes ambulatorios, hombres y mujeres, con diagnóstico bien establecido de Fibrosis Pulmonar Idiopática. |
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E.1.1.1 | Medical condition in easily understood language |
Men and women who are diagnosed with a lung disease that is characterized by scarring of the lung tissue, idiopathic pulmonary fibrosis. |
Hombres y mujeres a los que se les diagnostique una enfermedad pulmonar de que se caracteriza por presentar cicatrices en el tejido de los pulmones, fibrosis pulmonar idiopática. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Parasitic Diseases [C03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021240 |
E.1.2 | Term | Idiopathic pulmonary fibrosis |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 |
Evaluate the efficacy of oral cotrimoxazole versus placebo in idiopathic pulmonary fibrosis (IPF). |
Evaluar la eficacia del tratamiento con cotrimoxazol oral frente a placebo en la fibrosis pulmonar idiomática (FPI). |
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E.2.2 | Secondary objectives of the trial |
1. Evaluate the safety of oral cotrimoxazole versus placebo in IPF. 2. Evaluate the effect of cotrimoxazole on the natural history of Pneumocystis colonization in patients with IPF. 3. Identify the effects of cotrimoxazole systemic level of inflammatory activity in patients with IPF. |
1. Evaluar la seguridad del tratamiento con cotrimoxazol oral frente a placebo en la FPI. 2. Evaluar el efecto del cotrimoxazol sobre la historia natural de la colonización por Pneumocystis en pacientes con FPI. 3. Identificar los efectos del tratamiento con cotrimoxazol a nivel sistémico sobre la actividad inflamatoria en pacientes con FPI. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient, regardless of gender, aged 18 to 80 years. 2. Well-established diagnostic criteria of the FPI as ATA / ERS / JRS / ALAT 2011. 3. Ability to obtain a sample of sputum or oropharyngeal washing. 4. Forced Vital Capacity (FVC) above 50% from the theoretical value expected. 5. Distance traveled in the 6-minute test above 150 meters. 6. Normal serum levels of glucose-6-phosphate dehydrogenase. 7. Normal serum levels of vitamin B12. 8. Patient compliance or legal guardian to participate in this study by signing the informed consent. |
1. Paciente, independientemente del género, con edad entre 18 y 80 años. 2. Diagnóstico bien establecido de FPI según criterios de la ATA/ERS/JRS/ALAT 2011. 3. Posibilidad de obtener una muestra de esputo o lavado orofaríngeo. 4. Capacidad Vital Forzada (CVF) superior al 50% respecto del valor teórico esperado. 5. Distancia recorrida en la prueba de los 6 minutos superior a 150 metros. 6. Niveles séricos normales de glucosa-6-fosfato deshidrogenada. 7. Niveles séricos normales de vitamina B12. 8. Conformidad del paciente o su representante legal a participar en este estudio mediante la firma del consentimiento informado. |
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E.4 | Principal exclusion criteria |
1. Allergy / hypersensitivity or known gastrointestinal intolerance to cotrimoxazole 2. Use of immunosuppressants or corticosteroids in the previous 90 days at baseline. 3. Exacerbation of IPF and / or pneumonia in the 90 days prior to baseline. 4. Diagnosis confirmed or suspected neoplasia. 5. Diagnosis of liver cirrhosis or chronic hepatitis. 6. Presence of autoimmune diseases or asthma. 7. Presence of HIV infection 8. Patients with other significant diseases other than IPF. It is considered significant disease any disease or condition that, in the investigator's opinion, may jeopardize the patient's health participating in the study or influence the results of the study or the patient's ability to participate in the study. 9. Pregnant or lactating or of childbearing potential not using medically approved contraceptive methods at least three months before or during trial. 10. Participation in another trial with an investigational drug within 30 days or six half-lives (the larger of the two) above the baseline. 11. Inability to follow the patient. 12. Elevated liver function tests (ALT, AST or total bilirubin> 2 x upper limit of normal). 13. Creatinine clearance <30 ml / min. |
1. Alergia/hipersensibilidad o intolerancia digestiva conocida al cotrimoxazol 2. Utilización de inmunosupresores o corticoides sistémicos en los 90 días anteriores al inicio del estudio. 3. Exacerbación de la FPI y/o neumonía en los 90 días anteriores al inicio del estudio. 4. Diagnóstico confirmado o sospecha de neoplasia. 5. Diagnóstico de cirrosis hepática o hepatitis crónica 6. Presencia de enfermedades autoinmunes o asma 7. Presencia de infección por el VIH 8. Pacientes con otras enfermedades significativas que no sean FPI. Se considera enfermedad significativa cualquier enfermedad o afección que, a juicio del investigador, pueda poner en riesgo la salud del paciente por participar en el estudio o influir sobre los resultados del estudio o sobre la capacidad del paciente para participar en el estudio. 9. Mujeres embarazadas o lactantes o en edad fértil que no estén utilizando métodos anticonceptivos autorizados médicamente como mínimo tres meses antes del ensayo o durante éste. 10. Participación en otro ensayo con un fármaco en investigación en los 30 días o seis semividas (la mayor de las dos) anteriores al inicio del estudio. 11. Imposibilidad de seguimiento del paciente 12. Elevación de las pruebas de función hepática (ALT, AST ó bilirrubina total > 2 x límite superior de la normalidad). 13. Aclaramiento de creatinina < 30 ml/minuto. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Decline in FVC of the theoretical value ? 5% at 24 weeks and / or hospitalization for respiratory causes. |
Descenso de la CVF respecto al valor teórico ? 5% a las 24 semanas y/o hospitalización por causa respiratoria. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- FVC categorized (scale with 5 layers) - Decreased DLco 10% - Acute exacerbation of IPF - Scales of dyspnea - Time to progression - Any cause of hospitalization - Overall mortality - Quality of life - Distance traveled in the 6-minute test run - Reduction ? 50% at 24 weeks in the values ??of different proinflammatory cytokines - Reduction ? 50% at 24 weeks in the values ??of surfactant proteins A and / or D - Reduction ? 50% at 24 weeks in the values ??of CCL-18. - Incidence and severity of adverse events. |
- CVF categorizada (escala con 5 estratos) - Descenso de la DLco 10% - Exacerbación aguda de la FPI - Escalas de disnea - Tiempo hasta la progresión - Hospitalización por cualquier causa - Mortalidad global - Calidad de vida - Distancia recorrida en la prueba de los 6 minutos de marcha - Reducción ? 50% a las 24 semanas en los valores de las diferentes citoquinas proinflamatorias - Reducción ? 50% a las 24 semanas en los valores de las proteínas surfactantes A y/o D - Reducción ? 50% a las 24 semanas en los valores de CCL-18. - Incidencia y severidad de acontecimientos adversos. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, weeks 2, 4, 6, 12, 18, 24 and 28 |
Selección y semanas 2, 4, 6, 12, 18, 24 y 28 de tratamiento. |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
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
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final visit of last patient included |
última visita del último paciente reclutado |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |