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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   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:2007-007481-38
    Sponsor's Protocol Code Number:C07-25
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-03-11
    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 number2007-007481-38
    A.3Full title of the trial
    Effet d'un antagoniste du récepteur de l'endothéline 1 (Sitaxentan, Thelin) sur le remodelage bronchique au cours de l'asthme sévère avec obstruction bronchique persistante.
    A.3.2Name or abbreviated title of the trial where available
    Entholéine et remodelage bronchique dans l'asthme sévère
    A.4.1Sponsor's protocol code numberC07-25
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorINSERM
    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 Sitaxentan
    D.2.1.1.2Name of the Marketing Authorisation holderEncysive (UK) Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/234
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    asthme persistant modéré à sévère
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003554
    E.1.2Term Asthma aggravated
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer, chez les patients ayant un asthme avec TVO (Trouble Ventilatoire Obstructif) fixé, l'effet d'un traitement par le sitaxentatn, à celui du placebo en termes d'évolution des paramètres histologiques de remodelage bronchique sur 12 mois (réduction de la surface musculaire lisse bronchique et réduction du nombre de fibroblastes sous muqueux).
    E.2.2Secondary objectives of the trial
    Comparer sur 12 mois, chez les patients ayant un asthme avec TVO fixé, l'effet d'un traitement par le sitaxentant, à celui du placebo
    - en termes de paramètres clinique; variation de l'obtruction bronchique (VEMS), nombres d'exacerbations, dose de corticoïdes inhalés, nombre de cortcoïdes oraux.
    - en terme d'inflammation bronchique (fraction exhalée du NO et expectoration induite)

    Comparer la qualité de vie des patients entre les groupes sitaxentant et placebo à 12 mois
    Décrier la tolérance du traitement par sitaxentant dans le contexte de l'asthme avec TVO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age de 18 à 70 ans
    - Asthme persistant modéré à sévère évoluant depuis plus d’un an, et dont le VEMS pré-beta2 mimétique est inférieur à 70 % de la valeur théorique, malgré un traitement jugé optimal instauré depuis au moins 1 an par un médecin spécialisé dans l’asthme.
    - Suivi depuis au moins 12 mois à la consultation de pneumologie de l’hôpital Bichat pour son asthme
    - Bonne compliance au traitement de son asthme (avis de l’investigateur)
    - Stabilité de l’asthme à l’inclusion (pas de décompensation dans les 3 semaines précédentes (aggravation des symptômes et/ou de l’obstruction bronchique ayant nécessité une prise de corticoïdes oraux dans les 3 semaines précédentes)).
    - Réalisation d’un examen médical préalable
    - Consentement éclairé écrit et signé
    E.4Principal exclusion criteria
    - Grossesse ou allaitement (dosage de HCG positif)
    - Femme en âge de procréer sans contraception fiable ou dont la contraception est orale
    - Tabagisme actif ou tabagisme ancien (sevré depuis une durée inférieure à 5 ans), si supérieur à 10 PA
    - Absence d’affiliation à un régime de sécurité sociale ou à la CMU (bénéficiaire ou ayant droit)
    - Hypersensibilité connue au sitaxentan (ou à l’un des excipients du comprimé) (prurit, éruption cutanée)
    - Patients traités pour une autre affection que l’asthme
    - Insuffisance hépatique modérée à sévère correspondant à la classe B ou C de la classification de Child-Pugh
    - Taux sériques des aminotransférases hépatiques, aspartate aminotransférases (ASAT) et/ou alanine aminotransférases (ALAT), supérieurs à 3 fois la limite supérieure de la normale avant la mise en route du traitement
    - Association à la ciclosporine A, au glibenclamide, au fluconazole ou à un inhibiteur de CYP3A4 et d’un inhibiteur de CYP2C9
    - Patient sous traitement anticoagulant
    E.5 End points
    E.5.1Primary end point(s)
    - Variation de la surface de muscle lisse bronchique entre les biopsies bronchiques réalisées à l’inclusion et à 12 mois
    - Variation du nombre de fibroblastes sous muqueux entre les biopsies bronchiques réalisées à l’inclusion et à 12 mois
    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 Yes
    E.6.13.1Other scope of the trial description
    Etude preuve de concept
    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 No
    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.8.3 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 months
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state50
    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 Decision2008-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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