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    Summary
    EudraCT Number:2008-004737-13
    Sponsor's Protocol Code Number:CHUBX 2008/09
    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:2009-04-01
    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 number2008-004737-13
    A.3Full title of the trial
    Etude en double insu des effets du gallopamil sur le remodelage musculaire lisse bronchique chez l'asthmatique sévère
    A.3.2Name or abbreviated title of the trial where available
    Remodel'asthme
    A.4.1Sponsor's protocol code numberCHUBX 2008/09
    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 SponsorCHU de Bordeaux
    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 PROCORUM
    D.2.1.1.2Name of the Marketing Authorisation holderAbott GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namegallopamil hydrochloride
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codegallopamil hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer les effets in vivo du gallopamil après 12 mois de traitement per os, dans un essai randomisé contre placebo de patients asthmatiques sévères, sur le remodelage du muscle lisse bronchique déterminé ex vivo en microscopie optique et immunohistochimie.
    E.2.2Secondary objectives of the trial
    Comparer les effets in vivo du gallopamil, après 12 mois de traitement per os, dans un essai randomisé contre placebo, sur :
    - le remodelage musculaire lisse déterminé ex vivo en microscopie électronique
    - le nombre et l’activité des mitochondries du muscle lisse in vitro (14)
    - l’épaisseur bronchique estimée in vivo par une analyse 3D au scanner (19)
    - le contrôle de l’asthme selon les critères de Juniper (20), le niveau d’inflammation bronchique, le nombre de soins d’urgence.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Homme ou femme âgé d’au moins 18 ans
    - Ayant donné son consentement éclairé par écrit
    - Diagnostic d’asthme sévère dérivé des critères de l’ATS (23-25)
    - Au moins 1 critère majeur : Contrôle de l’asthme nécessitant :
    1. un traitement continu ou semi continu (≥ 50%) par corticoïdes oraux
    2. un traitement par fortes doses de corticoïdes inhalés (>1260 µg/j de béclométhasone, ou >1200 µg/j budesonide, ou >880 µg/j fluticasone)
    - Au moins 2 critères mineurs :
    1. Nécessité d’un traitement additionnel quotidien (β2-agonistes longue durée d’action, théophyllines, anti-leucotriènes)
    2. Symptômes nécessitant la prise quotidienne ou quasi-quotidienne de β2 agonistes de courte durée d’action
    3. Obstruction persistante (VEMS < 80%, variabilité du DEP > 20%)
    4. Un ou plusieurs recours aux soins en urgence / an
    5. Au moins trois cures courtes de corticoïdes oraux
    6. Aggravation rapide provoquée par la baisse de 25% de la dose de corticoïdes oraux ou inhalés
    7. ATCD d’asthme aigu grave ayant mis en jeu le pronostic vital
    E.4Principal exclusion criteria
    - Patient fumeur actif (tabac ou cannabis) ou ex-fumeur (> 10 paquets-année et/ou arrêt datant de moins de 3 ans)
    - Sujet ayant présenté une exacerbation de leur maladie asthmatique dans les 6 semaines précédant leur inclusion
    - Sujet privé de liberté par décision judiciaire ou administrative
    - Majeur protégé par la loi
    - Sujet non affilié à un régime de sécurité sociale, ou non bénéficiaire d’un tel régime
    - Sujet en période d’exclusion relative par rapport à un autre protocole ou pour lequel le montant annuel des indemnités maximum de 3800 euros a été atteint
    - Infections virales chroniques (hépatites, VIH)
    - Aspergillose broncho-pulmonaire allergique, aspergillose pulmonaire invasive aiguë
    - Femme enceinte ou allaitante
    - Femme en âge de procréer sans moyen de contraception efficace
    - Contre-indications du gallopamil : Bloc auriculoventriculaire du 2ème et 3ème degré, bloc sino-auriculaire non appareillé, maladie rythmique auriculaire, syndrome de WOLFF-PARKINSON-WHITE, insuffisance cardiaque non contrôlée, infarctus du myocarde en phase aiguë, choc cardiogénique, hypotension artérielle (systolique inférieure à 90 mm Hg), bradycardie < 50/min, troubles de la conduction intra-ventriculaire, traitement par bêta-bloquant, digitalique, autre inhibiteur calcique, autre anti-arythmique, ivabradine (Procoralan®), triazolam (Halcion®) ou dantrolène (Dantrium®), hépatopathie, porphyrie.
    - Critères de non-inclusion spécifiques à l’endoscopie : Hémostase anormale, pathologie cardiaque évolutive ou mal contrôlée, sujet n’étant pas à jeun depuis plus de 6 heures.
    E.5 End points
    E.5.1Primary end point(s)
    Remodelage du muscle lisse bronchique (surface du muscle lisse bronchique normalisée sur la surface totale de la paroi bronchique) mesuré ex vivo en microscopie optique
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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 years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state32
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 32
    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 Decision2009-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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