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    Summary
    EudraCT Number:2018-002563-25
    Sponsor's Protocol Code Number:IJG-AB4T-2018
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-10
    Trial 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 number2018-002563-25
    A.3Full title of the trial
    Effectiveness of antitussive, anticholinergic and honey therapy versus usual practice in adults with uncomplicated acute bronchitis [AB4T study]
    Efectividad del tratamiento antitusígeno, anticolinérgico y miel versus práctica habitual en adultos con bronquitis aguda no complicada [estudio AB4T]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of antitussive, anticholinergic and honey therapy versus usual practice in adults with uncomplicated acute bronchitis [AB4T study]
    Efectividad del tratamiento antitusígeno, anticolinérgico y miel versus práctica habitual en adultos con bronquitis aguda no complicada [estudio AB4T]
    A.3.2Name or abbreviated title of the trial where available
    AB4T study
    AB4T study
    A.4.1Sponsor's protocol code numberIJG-AB4T-2018
    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 SponsorIDIAP Jordi Gol
    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 supportresearch grant from the Carlos III Institute of Health, Ministry of Economy and Competitiveness (Spain)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIAP Jordi Gol
    B.5.2Functional name of contact pointUnitat Estudis Medicament
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08007
    B.5.3.4CountrySpain
    B.5.4Telephone number34934824644
    B.5.5Fax number34934824174
    B.5.6E-mailagarcia@idiapjgol.org
    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.2.1.2Country 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.3.1Product nameDextrometorfano
    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 INNDEXTROMETHORPHAN HYDROBROMIDE
    D.3.9.3Other descriptive namedextrometorfano
    D.3.9.4EV Substance CodeSUB01645MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 2
    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.2.1.2Country 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.3.1Product nameBromuro de Ipratropio
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIPRATROPIUM BROMIDE
    D.3.9.1CAS number 22254-24-6
    D.3.9.4EV Substance CodeSUB08276MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cough in the context of acute bronchitis
    Tos en el contexto de una bronquitis aguda
    E.1.1.1Medical condition in easily understood language
    Acute bronchitis with cough
    Bronquitis aguda con tos
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10006451
    E.1.2Term Bronchitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 clinical effectiveness of adding 3 symptomatic treatments (dextromethorphan, ipratropium bromide or honey) to normal practice in the reduction of days with moderate-severe cough compared with usual practice
    Evaluar la efectividad clínica de añadir a la práctica habitual 3 tratamientos sintomáticos (dextrometorfano, bromuro de ipratropio o miel) en la reducción de días con tos moderada-grave comparado con la práctica habitual
    E.2.2Secondary objectives of the trial
    To evaluate the clinical effectiveness of adding 3 symptomatic treatments to the usual practice compared to the usual clinical practice in:
    - The reduction of days until resolution of acute bronchitis
    - Reduction of days with moderate-severe diurnal cough
    - The reduction of days with moderate-severe nighttime cough
    - Duration in days of cough
    - The duration in days of severe symptoms
    - The duration in days of severe or moderate symptoms
    - According to the basal degree of bronchial hyperreactivity quantified by peak-flow
    - The use of antibiotics and different symptomatic treatments
    - The number of days of absenteeism
    - The number of times the patient returns to consult
    - The number of complications
    - Patient satisfaction

    Evaluate the adverse reactions in each of the test strategies
    Evaluar la efectividad clínica de añadir a la práctica habitual 3 tratamientos sintomáticos comparado con la práctica clínica habitual en:
    - La reducción de días hasta resolución de la bronquitis aguda
    - La reducción de días con tos moderada-grave diurna
    - La reducción de días con tos moderada-grave nocturna
    - La duración en días de tos
    - La duración en días de síntomas graves
    - La duración en días de síntomas graves o moderados
    - Según el grado basal de hiperreactividad bronquial cuantificado por peak-flow
    - El uso de antibióticos y distintos tratamientos sintomáticos
    - El número de días de absentismo laboral
    - El número de veces que el paciente vuelve a acudir a consulta
    - El número de complicaciones
    - La satisfacción de los pacientes

    Evaluar las reacciones adversas en cada una de las estrategias de ensayo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 18 years or older, who come to the primary care physician with cough of up to 3 weeks of evolution in the context of acute bronchitis and who agree to participate in the clinical trial.
    - Patients who score ≥4 in daytime and / or nighttime on the Likert scale of 6 points.
    - Pacientes de 18 años o más, que acudan al médico de atención primaria con tos de máximo 3 semanas de evolución en el contexto de una bronquitis aguda y que acepten participar en el ensayo clínico.
    - Pacientes que puntúen ≥4 en tos diurna y/o nocturna en la escala Likert de 6 puntos.
    E.4Principal exclusion criteria
    - Suspected pneumonia.
    - Patient with criteria for hospital referral
    - Pregnancy or lactation.
    - Basic respiratory disease: chronic obstructive pulmonary disease, asthma, tuberculosis or bronchiectasis.
    - Associated significant comorbility: moderate-severe heart failure, dementia, acute myocardial infarction / recent stroke (<3 months), severe hepatic insufficiency, severe renal insufficiency.
    - Immunosuppression.
    - Active neoplasia
    - Terminal disease
    - History of intolerance or allergy to any of the study treatments.
    - Patients in whom, in the opinion of the researcher, treatment with dextromethorphan, ipratropium bromide or honey is contraindicated.
    - Institutionalized patients.
    - Difficulty making scheduled follow-up visits.
    - Sospecha de neumonía.
    - Paciente con criterios de derivación hospitalaria
    - Embarazo o lactancia.
    - Enfermedad respiratoria de base: enfermedad pulmonar obstructiva crónica, asma, tuberculosis o bronquiectasias.
    - Comorbilidad significativa asociada: insuficiencia cardíaca moderada-grave, demencia, infarto agudo de miocardio / accidente vascular cerebral reciente (<3 meses), insuficiencia hepática severa, insuficiencia renal severa.
    - Inmunosupresión.
    - Neoplasia activa
    - Enfermedad terminal
    - Historia de intolerancia o alergia a alguno de los tratamientos de estudio.
    - Pacientes en los que, a juicio del investigador, esté contraindicado el tratamiento con dextrometorfano, bromuro de ipratropio o miel.
    - Pacientes institucionalizados.
    - Dificultad para realizar las visitas programadas de seguimiento.
    E.5 End points
    E.5.1Primary end point(s)
    Day reduction in the duration of moderate-severe cough
    Reducción de días en la duración de la tos moderada-grave
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily evaluation by the patient's diary, which is collected in the face-to-face visit on day 15 and, if necessary, on the 29th day.
    Evaluación diaria mediante diario del paciente, que se recoge en visita presencial día 15 y de ser necesario, día 29.
    E.5.2Secondary end point(s)
    Duration in days of:
    - symptomatology
    - moderate-severe diurnal cough
    - moderate-severe nighttime cough
    - cough
    - severe symptoms
    - severe or moderate symptoms
    Bronchial hyperreactivity degree difference
    Use of antibiotics and other symptomatic treatments
    Number of days of absenteeism
    Number of times the patient returns to consult
    Number of complications
    Degree of satisfaction
    Number of adverse reactions
    Duración en días de:
    - sintomatología
    - tos moderada-grave diurna
    - tos moderada-grave nocturna
    - tos
    - síntomas graves
    - síntomas graves o moderados
    Diferencia grado hiperreactividad bronquial
    Uso de antibióticos y otros tratamientos sintomáticos
    Número de días de absentismo laboral
    Número de veces que el paciente vuelve a acudir a consulta
    Número de complicaciones
    Grado de satisfacción
    Número de reacciones adversas
    E.5.2.1Timepoint(s) of evaluation of this end point
    The variables evaluated by reduction in days will be collected daily by the patient in the symptom diary, of 14 days and, if necessary, 28 days. The researcher will collect and review the diary in the face-to-face visits of the 15th and 29th.
    Difference degree bronchial hyperreactivity: day 15
    Use of antibiotics and other symptomatic treatments: day 15 and day 29
    Number of days of work absenteeism: day 15
    Number of times the patient returns to consult: day 29 and call day 42
    Number of complications: day 29 and call day 42
    Degree of satisfaction: day 15 or day 29
    Number of adverse reactions: day 15 and day 29
    Las variables evaluadas mediante reducción en días las recogerá diariamente el paciente en el diario de sintomatología, de 14 días y si es necesario de 28 días. El investigador recogerá y revisará el diario en las visitas presenciales del día 15 y día 29.
    Diferencia grado hiperreactividad bronquial: día 15
    Uso de antibióticos y otros tratamientos sintomáticos: día 15 y día 29
    Número de días de absentismo laboral: día 15
    Número de veces que el paciente vuelve a acudir a consulta: día 29 y llamada día 42
    Número de complicaciones: día 29 y llamada día 42
    Grado de satisfacción: día 15 o día 29
    Número de reacciones adversas: día 15 y día 29
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Miel (3r brazo) y práctica clínica habitual (comparador)
    Honey (3rd arm) and usual care (comparator)
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    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
    LVLS
    LVLS
    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 months1
    E.8.9.1In the Member State concerned days15
    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) Yes
    F.1.2.1Number of subjects for this age range: 508
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state668
    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)
    As treatments used in this trial are already common use, once the trial has ended, if the acute bronchitis is not solved patient will be treated by usual care.
    Los tratamientos de ensayo se utilizan de forma habitual en la práctica clínica. Si una vez finalizado el ensayo el paciente continúa teniendo sintomatología de bronquitis aguda, el médico lo tratará siguiendo la práctica clínica habitual.
    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 Decision2018-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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