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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2009-014421-16
    Sponsor's Protocol Code Number:EP-753-ZAM02
    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:2009-08-06
    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 number2009-014421-16
    A.3Full title of the trial
    ETUDE DE L'EFFICACITE ET DE LA TOLERANCE DE RHINOMAXIL (BECLOMETASONE) DANS LE TRAITEMENT DE LA RHINOSINUSITE INFECTIEUSE AIGUË DE L'ADULTE NE RELEVANT PAS D'UN TRAITEMENT ANTIBIOTIQUE. ETUDE MULTICENTRIQUE, COMPARATIVE VERSUS PLACEBO, RANDOMISEE EN DOUBLE AVEUGLE, EN 2 GROUPES PARALLELES
    A.4.1Sponsor's protocol code numberEP-753-ZAM02
    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 SponsorZAMBON France
    B.1.3.4CountryFrance
    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 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 Rhinomaxil 100 µg/dose, suspension pour pulvérisation nasale
    D.2.1.1.2Name of the Marketing Authorisation holderZambon France
    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.3.4Pharmaceutical form Nasal spray, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 08/09/5534
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 placeboNasal spray, suspension
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rhinosinusite infectieuse aiguë de l'adulte ne relevant pas d'un traitement antibiotique
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10052106
    E.1.2Term Rhinosinusitis
    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 d’un traitement local nasal par Rhinomaxil® à un traitement placebo, sur l’obstruction nasale au cours de la rhinosinusite infectieuse aiguë ne justifiant pas d’une antibiothérapie, après 4 jours de prise biquotidienne.
    E.2.2Secondary objectives of the trial
    - Comparer les effets de Rhinomaxil® à un placebo sur l’évolution clinique de la rhinosinusite aiguë (répondeurs / non répondeurs) à J10
    - Comparer les effets de Rhinomaxil® à un placebo sur l’évolution de la gêne liés aux symptômes de la rhinosinusite aiguë (obstruction, rhinorrhée, douleurs) évaluée par le patient tous les jours de J0 à J10.
    - Comparer les effets de Rhinomaxil® à un placebo sur la qualité du sommeil et sur la qualité de vie du patient à J4 et à J10.
    - Evaluer et comparer le taux de survenue de complication à V1 et à V2
    - Evaluer et comparer le taux de récidive à V2.
    - Evaluer la tolérance locale et globale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-Hommes ou femmes âgés de 18 à 75 ans,
    2-Présentant une rhinosinusite infectieuse aiguë (RSIA) ne relevant pas d’une antibiothérapie selon les critères des recommandations de l’AFSSAPS:
    3-Evoluant depuis au moins 3 jours (avis d’experts) et au maximum 10 jours
    4-Pour laquelle la gêne liée à la symptomatologie, évaluée au moment de l’inclusion par le patient sur une EVA, 0-10cm :
    - est supérieure à 5 sur l’EVA de l’obstruction nasale,
    - est supérieure à 10 sur 30 sur la somme des évaluations par échelles analogiques visuelles (EVA) des 3 principaux symptômes de la maladie étudiée : rhinorrhée, obstruction nasale, douleur ou pesanteur faciale.
    5-Ayant donné son consentement éclairé écrit pour participer à l’étude,
    E.4Principal exclusion criteria
    1-Patients présentant des signes d’une rhinosinusite bactérienne grave (RSIA ethmoïdale, frontale, sphénoïdale)
    2-Fièvre supérieure à 38°5, douleur faciale unilatérale, purulence de la rhinorrhée, tuméfaction du visage, céphalées profondes.
    3-Patients présentant une rhinosinusite chronique (symptomatologie évoluant depuis plus de 12 semaines)
    4-Patients en poussée allergique
    5-Patients ayant reçu une corticothérapie (voie générale, cutanée, inhalée ou nasale.) dans les 8 jours précédant l’inclusion.
    6-Patients ayant pris un vasoconstricteur (voie locale ou générale) dans les 48 heures précédant l’inclusion.
    7-Patients ayant reçu un antihistaminique H1 (voie locale ou générale) dans le mois précédant l’inclusion, y compris l’hydroxizine (Atarax®).
    8-Prise d’antitussifs dans les 8 jours précédant l’inclusion (pour les antitussifs anti-H1 : dans le mois précédant l’inclusion)
    9-Patients ayant pris un AINS dans les 48 heures
    10-Patients présentant des polypes nasaux
    11-Patients ayant un antécédent récent (3 mois) d’intervention chirurgicale ou de traumatisme au niveau du nez et des sinus
    12-Patients présentant des troubles de l’hémostase
    13-Patients ayant présenté une épistaxis dans le mois précédent
    14-Infection oro-bucco-nasale et ophtalmique par Herpès virus
    15-Patients diabétiques
    16-Patients présentant un cancer ORL.
    17-Patients ayant participé à un essai clinique au cours des 30 derniers jours ou qui participe actuellement à un autre essai,
    E.5 End points
    E.5.1Primary end point(s)
    Evolution entre la valeur à l’inclusion V0 et à J4 le soir, de l’intensité de la gêne liée à l’obstruction nasale, auto-évaluée par le patient sur une EVA.
    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 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) 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 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 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 concerned50
    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
    Dernière visite du dernier patient
    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 months5
    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 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 state400
    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)
    Expected normal treatment
    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 Decision2009-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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