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    Summary
    EudraCT Number:2012-002450-24
    Sponsor's Protocol Code Number:MV130-SLG-002
    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:2012-06-25
    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 number2012-002450-24
    A.3Full title of the trial
    Randomized double-blind placebo-controlled prospective, parallel, single centre clinical trial of bacterial vaccine (BACTEK ®) sublingual (oral mucosa) in patients with repeat bronchospasm for the immunomodulatory eficacy evaluation, security and clinical impact.
    ENSAYO CLÍNICO UNICÉNTRICO PROSPECTIVO ALEATORIZADO, DOBLE CIEGO, PARALELO CONTROLADO FRENTE A PLACEBO DE UNA VACUNA BACTERIANA (BACTEK®) POR VÍA SUBLINGUAL (EN MUCOSA ORAL) EN SUJETOS CON BRONCOESPASMO DE REPETICIÓN PARA LA EVALUACIÓN DE LA EFICACIA INMUNOMODULADORA, SEGURIDAD E IMPACTO CLÍNICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy and safety of Bactek
    Evaluación de la eficacia y seguridad de Bactek
    A.4.1Sponsor's protocol code numberMV130-SLG-002
    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 SponsorInmunotek S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInmunotek S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInmunotek S.L.
    B.5.2Functional name of contact pointMiguel Casanovas; Medical Director
    B.5.3 Address:
    B.5.3.1Street AddressVelázquez, 124
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number34916510010
    B.5.5Fax number34916639732
    B.5.6E-mailmcasanovas@inmunotek.com
    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 No
    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.3.1Product nameBactek
    D.3.2Product code MV130
    D.3.4Pharmaceutical form Sublingual spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    Sublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBactek
    D.3.9.1CAS number 8000045-24-1
    D.3.9.2Current sponsor codeMV130
    D.3.9.3Other descriptive nameALLERGENS, BACTERIA
    D.3.9.4EV Substance CodeSUB12782MIG
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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 placeboSublingual spray
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent bronchospasm
    Broncoespasmos de repetición
    E.1.1.1Medical condition in easily understood language
    Repeted bronchospasm
    Broncoespasmos de repetición
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006482
    E.1.2Term Bronchospasm
    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
    To evaluate the efficacy of a bacterial vaccine administered sublingually to prevent episodes of bronchospasm in patients with bronchospasm episodes induced by recurrent respiratory tract infections, compared with a placebo group
    El objetivo principal de este ensayo es evaluar la eficacia de una vacuna bacteriana administrada por vía sublingual para la prevención de episodios de broncoespasmo, en sujetos con episodios de broncoespasmo inducidos por infecciones recurrentes del tracto respiratorio, comparándola con un grupo placebo
    E.2.2Secondary objectives of the trial
    ? Shortening of bronchospasm episodes
    ? Rate of episodes
    ? Reduction in the antibiotics, oral corticosteroids, use of rescue bronchodilators and inhaled corticosteroid consumption
    ? Respiratory infections episodes reduction
    ? Direct costs: unscheduled visits to health center, emergency service visits, days of hospitalization and cost thereof, complementary tests, phone calls to the doctor or pediatrician
    ? Indirect costs: absenteeism from nursery, caregivers to the child at home and during hospital admissions.
    ? NNT to prevent one episode of bronchospasm
    ? Free day?s symptom percentage during the trial.
    ? Free day?s medication percentage of during the trial
    ? Safety Variables: adverse events, and evaluation of the local tolerability-reactions at the site of administration
    - Acortamiento de los episodios de broncoespasmo
    - Tasa de episodios
    - Disminución del consumo de antibioterapia, corticoide oral, del uso de broncodilatadores de rescate y corticoide inhalado
    - Disminución de los episodios de infecciones respiratorias
    - Costes directos: visitas a centro de salud no programadas, visitas a urgencias hospitalarias, días de ingreso hospitalario y coste del mismo, pruebas complementarias realizadas, llamadas telefónicas al médico especialista o pediatra.
    - Costes indirectos: absentismo escolar, cuidadores a cargo del niño en domicilio y durante los ingresos hospitalarios.
    - NNT para prevenir un episodio de broncoespasmo
    - Porcentaje de días sin síntomas a lo largo del ensayo.
    - Porcentaje de días sin medicación a lo largo del ensayo.
    - Variables de seguridad:Acontecimientos adversos y evaluación de la tolerabilidad local -reacciones en el lugar de la administración (y de cualquier medicación administrada para el tratamiento de AA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects whose parents /legal representative have given written informed consent.
    - Both gender
    - Subject up to 36 months of age.
    - Subjects with recurrent bronchospasms ; 3 or more exacerbations in the last 12 months
    - Sujetos cuyos padres/representantes legales hayan otorgado el consentimiento informado por escrito.
    - Ambos sexos
    - Sujetos de hasta 36 meses de edad.
    - Sujetos con broncoespasmo de repetición; 3 o más crisis en los últimos 12 meses
    E.4Principal exclusion criteria
    - Subjects whose parents/legal representative have not given written informed consent.
    - Subjects out of aged range
    - Subjects with malignancies or chemotherapy treatment
    - Subjects included in another clinical trial in the last 12 months.
    - Subject in immunosuppressive or immunostimulatory treatment
    - Subjects who have received iv gamma globulin in the past 12 months.
    - Subjects with recurrent respiratory infections
    - Subjects diagnosed with candidiasis or fungal recurrent infections.
    - Subjects diagnosed with malabsorption syndrome
    - Subjects with clinical allergy tocommon aeroallergens in the geographical area.
    - Subjects with hepatitis virus infections, HIV and tuberculosis
    - Sujetos cuyos padres/representantes legales no hayan otorgado el consentimiento informado por escrito.
    - Sujetos cuya edad no esté comprendida en el rango e establecido.
    - Sujetos con neoplasias o en tratamiento quimioterápico.
    - Sujetos incluidos en otro ensayo clínico en los últimos 12 meses.
    - Sujetos en tratamiento inmunosupresor o inmunoestimulante
    - Sujetos que han recibido gammaglobulina iv en los últimos 12 meses.
    - Sujetos con infecciones de repetición no respiratorias
    - Sujetos diagnosticados de candidiasis o infecciones fúngicas de repeición.
    - Sujetos diagnosticados de Síndrome malabsortivo
    - Sujetos con alergia clínica frente a neumoalergenos comunes en la zona geográfica.
    - Sujetos con infecciones por virus de hepatitis, VIH y tuberculosis
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to evaluate the efficacy of a bacterial vaccine, sublingally administered to prevent bronchospams episodes in subjects with bronchospam episodes compared with a placebo group
    El objetivo principal de este ensayo es evaluar la eficacia de una vacuna bacteriana administrada por vía sublingual para la prevención de episodios de broncoespasmo, en sujetos con episodios de broncoespasmo, comparándola con un grupo placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    The baseline and the end of the study
    Principio y el final del ensayo
    E.5.2Secondary end point(s)
    ? Shortening of bronchospasm episodes
    ? Rate of episodes
    ? Reduction in the antibiotics, oral corticosteroids, use of rescue bronchodilators and inhaled corticosteroid consumption
    ? Respiratory infections episodes reduction
    ? Direct costs: unscheduled visits to health center, emergency service visits, days of hospitalization and cost thereof, complementary tests, phone calls to the doctor or pediatrician
    ? Indirect costs: absenteeism from nursery, caregivers to the child at home and during hospital admissions.
    ? NNT to prevent one episode of bronchospasm
    ? Free day?s symptom percentage during the trial.
    ? Free day?s medication percentage of during the trial
    ? Safety Variables: adverse events, and evaluation of the local tolerability-reactions at the site of administration
    - Acortamiento de los episodios de broncoespasmo
    - Tasa de episodios
    - Disminución del consumo de antibioterapia, corticoide oral, del uso de broncodilatadores de rescate y corticoide inhalado
    - Disminución de los episodios de infecciones respiratorias
    - Costes directos: visitas a centro de salud no programadas, visitas a urgencias hospitalarias, días de ingreso hospitalario y coste del mismo, pruebas complementarias realizadas, llamadas telefónicas al médico especialista o pediatra.
    - Costes indirectos: absentismo escolar, cuidadores a cargo del niño en domicilio y durante los ingresos hospitalarios.
    - NNT para prevenir un episodio de broncoespasmo
    - Porcentaje de días sin síntomas a lo largo del ensayo.
    - Porcentaje de días sin medicación a lo largo del ensayo.
    - Variables de seguridad:Acontecimientos adversos y evaluación de la tolerabilidad local -reacciones en el lugar de la administración (y de cualquier medicación administrada para el tratamiento de AA
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Baseline
    - Visit 1 (2 months after baseline)
    - Visit 2 (2 months after visit 1)
    - Visit 3 (2 months after visit 2)
    - Visit 4 (3 months after visit 3)
    - Visit 5 (3 months after visit 4)
    - Visita basal
    - Visita 1 (2 meses después de la visita basal)
    - Visita 2 (2 meses después de la visita 1)
    - Visita 3 (2 meses después de la visita 2)
    - Visita 4 (3 meses después de la visita 3)
    - Visita 5 (3 meses después de la visita 4)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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
    Last patient last visit
    Última visita del último paciente
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 108
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 108
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 108
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects up to 36 months old
    Sujetos de hasta 36 meses de edad
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state108
    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 Decision2012-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-24
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