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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-005409-38
    Sponsor's Protocol Code Number:TriSulfa-FPI-1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-005409-38
    A.3Full title of the trial
    Pilot study phase III to evaluate the efficacy and safety of Trimethoprim-sulfamethoxazole in the treatment of idiopathic pulmonary fibrosis
    Estudio piloto fase III para evaluar la eficacia y seguridad de Trimetoprim-Sulfametoxazol en el tratamiento de la fibrosis pulmonar idiopática
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First study to test the validity of the treatment of the disease called idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with a drug called cotrimoxazole.
    Primer estudio para comprobar la validez del tratamiento de la enfermedad llamada Fibrosis Pulmonar Idiopática, que produce inflamación y fibrosis (cicatrices) del tejido de los pulmones, con un fármaco llamado cotrimoxazol.
    A.4.1Sponsor's protocol code numberTriSulfa-FPI-1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJunta de Andalucia
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUICEC-H. U. Virgen del Rocío
    B.5.2Functional name of contact pointClara Rosso
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Manuel Siurot
    B.5.3.2Town/ citySeville
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955013414
    B.5.5Fax number0034954232992
    B.5.6E-mailfernando.perez.exts@juntadeandalucia.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SEPTRIN
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIMETHOPRIM
    D.3.9.3Other descriptive nameTRIMETHOPRIM
    D.3.9.4EV Substance CodeSUB11310MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSULFAMETHOXAZOLE
    D.3.9.1CAS number 723-46-6
    D.3.9.4EV Substance CodeSUB10711MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical 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.
    E.1.1.1Medical 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.
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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).
    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary 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.
    E.5.2.1Timepoint(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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    final visit of last patient included
    última visita del último paciente reclutado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
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