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    The EU Clinical Trials Register currently displays   42556   clinical trials with a EudraCT protocol, of which   7007   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:2011-002261-38
    Sponsor's Protocol Code Number:P100504
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2011-07-01
    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 ConcernedFrance - ANSM
    A.2EudraCT number2011-002261-38
    A.3Full title of the trial
    Etude de la dose-réponse au bronchodilatateur puis recherche de dose du bronchodilatateur par la technique de l'interruption du débit chez l'enfant siffleur âgé de 2,5 à 6 ans - Etude DORESI.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etude de la relation entre dose et réponse au bronchodilatateur puis recherche de dose du bronchodilatateur par la mesure de la résistance respiratoire par la technique de l'interruption du débit chez l'enfant âgé de 2,5 à 6 ans atteint de sifflements respiratoires.
    A.3.2Name or abbreviated title of the trial where available
    DORESI
    A.4.1Sponsor's protocol code numberP100504
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 VENTOLINE 100 microgrammes/dose, suspension pour inhalation en flacon pressurisé
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameVENTOLINE 100 microgrammes/dose, suspension pour inhalation en flacon pressurisé
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNSalbutamol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 ug /par dose
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Enfants âgés de 2 ans 6 mois à 6 ans 11 mois adressés pour une Exploration Fonctionnelles Respiratoire avec test au bronchodilatateur, en raison de sifflements respiratoires récidivants.
    E.1.1.1Medical condition in easily understood language
    Enfants âgés de 2 ans 6 mois à 6 ans 11 mois adressés pour une Exploration Fonctionnelles Respiratoire avec test au bronchodilatateur, en raison de sifflements respiratoires récidivants.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10038683
    E.1.2Term Respiratory disorder
    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
    Estimer la relation dose-effet du bronchodilatateur chez le jeune enfant siffleur par la technique de l'interruption du débit aérien.
    E.2.2Secondary objectives of the trial
    Déterminer la dose minimale de bronchodilatateur à utiliser en routine lors d'un test au bronchodilatateur chez le jeune enfant siffleur pour entrainer une réversibilité.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Tout patient âgé de 2 ans 6 mois et 6 ans 11 mois adressé pour une Exploration Fonctionnelles Respiratoire avec test au bronchodilatateur, en raison de sifflements respiratoires récidivants à au moins 3 reprises dans l'année écoulée, aux laboratoires d'EFR de l'Hôpital Armand Trousseau, Robert Debré, Paris ou Arnaud de Villeneuve, Montpellier
    - Absence de prise de bronchodilatateur dans les 12 heures avant l'examen
    - Parents ayant donné leur consentement signé pour l'étude
    E.4Principal exclusion criteria
    - Tout patient âgé de 2 ans 6 mois et 6 ans 11 mois
    - ayant une autre pathologie pulmonaire connue (dyplasie broncho-pulmonaire, bronchite chronique, séquelle de virose, pathologie d'inhalation, malformation thoraco-pulmonaire, trachéomalacie), ou une anomalie anatomique ou fonctionnelle de la filière pharyngo-laryngée (amygdales jointives ou au contact de la luette, laryngomalacie, sténose sous-glottique, paralysie d'une corde vocale, tout obstacle laryngé)
    - ayant pris un traitement de fond par anti-leucotriènes dans la semaine avant l'examen.
    - ayant pris un traitement corticoïdes par voie générale dans les 15 jours avant l'examen.
    - L'absence de couverture sociale
    - L'opposition de la famille
    - Patient présentant ou ayant présenté une intolérance à la Ventoline
    E.5 End points
    E.5.1Primary end point(s)
    Variation de la mesure de la résistance respiratoire mesurée par la Rint.
    Mesure de la Rint de base et après administration de BD après chaque dose (n=2) (cumulée) de BD.
    La variation de Rint est exprimée en pourcentage du prédit pour chaque dose (n=2) (cumulée).
    E.5.2Secondary end point(s)
    La réponse positive au BD est définie par une chute d'au moins 35% de la valeur prédite pour la taille de la résistance respiratoire mesurée par la Rint.
    Effet sur la réactivité bronchique de la prise d'un traitement de fond, de l'existence d'une atopie ou de symptômes récents. La cinétique de la dose-effet du BD sera étudiée en fonction des paramètres cliniques, en particulier, de l'existence d'une atopie familiale ou personnelle, de symptômes respiratoires récents définissant le contrôle de la maladie, et de l'auscultation pulmonaire normale ou anormale le jour de l'examen.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    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 Information not present in EudraCT
    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
    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 Yes
    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) Yes
    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 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 state90
    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 Decision2011-06-09
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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