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    Summary
    EudraCT Number:2011-004830-32
    Sponsor's Protocol Code Number:ICPCT-2011-UA-FF
    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:2011-11-29
    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 number2011-004830-32
    A.3Full title of the trial
    Effects of bilastine on nasal volume after allergen-induced rhinitis in patients with allergic rhinitis
    Eficacia de bilastina sobre la obstrucción nasal en un modelo clínico de provocación nasal con alérgeno en sujetos con rinitis alérgica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of bilastine on nasal volume after allergen-induced rhinitis in patients with allergic rhinitis
    Eficacia de bilastina sobre la obstrucción nasal en un modelo clínico de provocación nasal con alérgeno en sujetos con rinitis alérgica
    A.4.1Sponsor's protocol code numberICPCT-2011-UA-FF
    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 SponsorFAES FARMA, S.A.
    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 supportFAES FARMA, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clinic i Provincial de Barcelona
    B.5.2Functional name of contact pointUnitat d'Al.lèrgia
    B.5.3 Address:
    B.5.3.1Street Addressc/ Villarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932275540
    B.5.5Fax number+34934227983
    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 Bilaxten 20 mg, comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderFAES FARMA, 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.3.1Product nameBilastina
    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 INNBilastina
    D.3.9.1CAS number 202189-78-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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
    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
    Allergic Rhinitis
    Rinitis alérgica
    E.1.1.1Medical condition in easily understood language
    Allergic Rhinitis
    Rinitis alérgica
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10039085
    E.1.2Term Rhinitis allergic
    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
    Assess the effects of Bilastine on nasal obstruction in allergic rhinitis patients after nasal provocation with allergen.
    Valorar los efectos de bilastina sobre la obstrucción nasal en pacientes con rinitis alérgica tras la provocación nasal con alérgeno.
    E.2.2Secondary objectives of the trial
    Assess the effects of bilastine on nasal symptomatology evaluated by a symptoms score and by a visual analog scale after nasal provocation with allergen.
    Valoración de los efectos de bilastina sobre la sintomatología nasal evaluada mediante puntuación de síntomas y mediante una escala visual analógica tras la provocación nasal con el alérgeno.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients between 18 and 70 years.
    2. Documented medical records of pollen-induce rhinitis at least two years preceding the screening visit.
    3. Skin tests and/or positive specific IgE determination for some inhalant allergen/s.
    4. Written informed consent that is consistent with ICH-GCP guidelines.
    1. Hombres o mujeres entre 18 y 70 años.
    2. Historia documentada de rinitis alérgica inducida por pólenes desde al menos 2 años anteriores a la visita de selección.
    3. Pruebas cutáneas y/o la determinación de IgE especifica positivas a algún/os alérgeno/s inhalantes.
    4. Pacientes que hayan otorgado su consentimiento informado para participar en el estudio.
    E.4Principal exclusion criteria
    1. Allergic rhinitis symptoms presence.
    2. Any type of physical abnormality (nasal septum deviation, recent nasal surgery, etc.), which could interfere with the study objectives.
    3. Bilastine or any of its excipients hypersensitivity.
    4. Use of any intranasal medication.
    5. Patients on oral or systemic treatment for allergic rhinitis that will not complied with the following washout periods prior to their inclusion in the study:
    - depot corticosteroids (3 months), systemic or topical (4 weeks).
    - Antihistamine drugs: astemizole (6 weeks), elastin, loratadine and desloratadine (10 days), other systemic antihistamine drugs (3 days).
    - Antileukotriene drugs (3 days)
    - Ketotifen (2 weeks)
    - Drugs with antihistaminic properties (phenothiazine)
    - Cromoglicic acid, nedocromil (2 weeks)

    For treatments that don't specify a washout period in parentheses, it's enough to stop the treatment the day of inclusion in the trial.

    6. History of non-allergic rhinitis (vasomotor, infectious, drug induced, etc.).
    7. Chronic sinusitis or severe bronchial asthma.
    8. Respiratory infection within 30 days before the start of the study.
    9. Concomitant serious disease that could interfere with response to treatment (hepatic, renal, cardiovascular) or malignancy.
    10. Patients with mental illness that prevents the subject understand the nature, purpose and implications of the study or patients who are unable to sign informed consent.
    11. Patients with known unresponsiveness to H1 antihistamine drugs.
    1. Presencia de síntomas de rinitis alérgica.
    2. Cualquier tipo de anomalía física (desviación de tabique nasal, cirugía nasal reciente, etc.), que pudiera interferir con los objetivos del estudio.
    3. Hipersensibilidad conocida a bilastina o a cualquiera de sus excipientes.
    4. Uso de cualquier medicación por vía intranasal.
    5. Pacientes en tratamiento sistémico u oral para su rinitis alérgica que no respeten los siguientes periodos de lavado previos a su inclusión en el estudio:
    - Corticoides depot (3 meses), sistémicos o tópicos (4 semanas).
    - Antihistamínicos: Astemizol (6 semanas), elastina, loratadina y desloratadina (10 días), otros antihistamínicos sistémicos (3 días).
    - Antileucotrienos (3 días)
    - Ketotifeno (2 semanas)
    - Fármacos con propiedades antihistamínicas (fenotiazina)
    - Cromoglicato sódico, nedocromil (2 semanas)

    Para los tratamientos que no especifican un periodo de lavado entre paréntesis, se considera suficiente con interrumpir el tratamiento el día de comienzo del estudio.
    6. Historia de rinitis no alérgica (vasomotora, infecciosa, inducida por fármacos, etc.).
    7. Sinusitis crónica o asma bronquial severo.
    8. Infección respiratoria en los 30 días previos al inicio del estudio.
    9. Enfermedad grave concomitante que pueda interferir con la respuesta al tratamiento (hepática, renal, cardiovascular) o neoplasias.
    10. Pacientes con enfermedad mental que impida al sujeto entender la naturaleza, objetivo y consecuencias del estudio o pacientes que no puedan firmar el consentimiento informado.
    11. Pacientes con falta de respuesta conocida a antihistamínicos H1.
    E.5 End points
    E.5.1Primary end point(s)
    Parameters to be evaluated by acoustic rhinometry are: a) nasal volume from 2-7 cm. from narine in both nostrils and b) the minimum transverse area (ATM) from 1 cm. from the narine.
    Los parámetros que se evaluarán, mediante rinometría acústica son: a) el volumen nasal entre 2-7 cm. desde la narina en ambas fosas nasales y b) el área transversa mínima (ATM) a partir de 1 cm. desde la narina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal, at 15, 30 and 60 minutes after nasal provocation with an allergen.
    Basal, a los 15, 30 y 60 minutos tras la provocación nasal con alérgeno
    E.5.2Secondary end point(s)
    Evaluation of the clinical response will be done by the patient taking into account the intensity of the following nasal symptoms: rhinorrhea, itching, obstruction and sneezing.
    La evaluación de la respuesta clínica será realizada por el paciente por medio de la intensidad de los siguientes síntomas nasales: rinorrea, picor, obstrucción, y estornudos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Basal, at 15, 30 and 60 minutes after nasal provocation with an allergen.
    Basal, a los 15, 30 y 60 minutos tras la provocación nasal con alérgeno
    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 No
    E.6.4Safety No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 (Última visita del último paciente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    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 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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state12
    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)
    No plans different from the expected normal treatment of that condition are expected
    No hay planes de tratamiento diferentes de los tratamientos normales para esta condición
    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 Decision2012-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-28
    P. End of Trial
    P.End of Trial StatusOngoing
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