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    Summary
    EudraCT Number:2020-003010-12
    Sponsor's Protocol Code Number:APHP180600
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-10-16
    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 number2020-003010-12
    A.3Full title of the trial
    «Efficacy of Fluticasone Propionate associated with Salmeterol using inhalation chamber versus placebo to improve the respiratory function in children over six years of age who underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥10% from pre transplantation»
    Efficacité de l'association du Fluticasone Salméterol versus Placebo chez les enfants de 6 ans ou plus, allogreffés de moelle présentant un déclin du VEMS de 10% ou plus par rapport à la greffe.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Fluticasone Propionate associated With Salmeterol underwent allogeneic hematopoietic stem cell transplantation
    Efficacité de l'association du Fluticasone Salméterol versus Placebo chez les enfants de 6 ans ou plus, allogreffés de moelle présentant un déclin du VEMS de 10% ou plus par rapport à la greffe.
    A.3.2Name or abbreviated title of the trial where available
    RESPPEDOPS
    RESPPEDOPS
    A.4.1Sponsor's protocol code numberAPHP180600
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI Hopital Saint louis
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number01 44 84 17 17
    B.5.6E-mailfadila.amerali@aphp.fr
    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 SERETIDE 125 microgrammes/25 microgrammes/dose, suspension pour inhalation en flacon pressurisé avec valve doseuse
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Glaxosmithkline
    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 Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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) 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.IMP: 2
    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 SERETIDE 50 microgrammes/25 microgrammes/dose, suspension pour inhalation en flacon pressurisé avec valve doseuse
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Glaxosmithkline
    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 Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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) 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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bronchiolitis Obliterative Syndrome after hematopoietic stem cell transplantation (HSCT).
    .
    Syndrome de Bronchiolite Obliterante apres greffe de CSH
    E.1.1.1Medical condition in easily understood language
    primary noninfectious pulmonary complication after hematopoietic stem cell transplantation (HSCT)
    Complication pulmonaire non infectieuse après greffe de moelle
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of a Fluticasone Propionate associated with Salmeterol using inhalation chamber compared to placebo on respiratory function at 6 months in children over six years of age who underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥ 10% from pre transplantation during the first
    year after transplantation.
    Evaluer l'effet d'un propionate de fluticasone associé au salmétérol en chambre d'inhalation par rapport à un placebo sur la fonction respiratoire à 6 mois chez les enfants de plus de 6 ans qui ont subi une greffe de cellules souches hématopoïétiques allogéniques avec un déclin du VEMS1 ≥ 10% depuis la pré transplantation durant la première année après la transplantation.
    E.2.2Secondary objectives of the trial
    To assess the effect of a Fluticasone Propionate associated with Salmeterol using inhalation chamber compared to placebo in children over six years old underwent allogeneic hematopoietic stem cell transplantation with a decline of FEV1 ≥ 10% from pre transplantation to 6 months following the initiation of the treatment on pulmonary function, respiratory symptoms, Bonchiolitis Obliterative Syndrome (BOS) rate, oral steroid exposure and the occurrence of infections.
    Evaluer l'effet d'un propionate de fluticasone associé au salmétérol en chambre d'inhalation comparativement au placebo chez des enfants de plus de six ans ayant subi une greffe de cellules souches hématopoïétiques allogéniques avec un déclin du VEMS de 10 % à 6 mois après le début du traitement, et 6 mois après la fin du traitement, sur la fonction pulmonaire, les symptômes respiratoires, le taux de la bronchiolite oblitérante (BO), l'exposition orale de stéroïde et la fréquence des infections ;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria before HCST :
    - Children and adolescent aged 6 to 17 years
    - Getting an Allo Hematopoietic cell stem transplantation
    - Provide written informed consent from legal guardian
    - Covered by medical insurance (sécurité sociale ou CMU).
    Randomisation criteria:
    - Decline of FEV1 ≥ 10% from pre transplantation between M3 and M12 after the transplantation, confirmed over two functional test performed one week apart, without BOS international criteria, neither initiation of inhaled treatment from transplantation to randomization visit.
    Critères d'inclusion avant HSCCST :
    - Enfants et adolescents de 6 à 17 ans
    - Obtenir une allogreffe de cellules souches hématopoïétiques
    - Fournir le consentement éclairé écrit du tuteur légal
    - Couvert par l'assurance médicale (sécurité sociale ou CMU).
    Critères de randomisation :
    - Baisse du VEMS ≥ 10 % du VEMS de la la pré transplantation à entre M3 et M12 après la transplantation, confirmée sur deux tests fonctionnels effectués à une semaine d'intervalle, sans critères internationaux BO, ni début du traitement par inhalation de la transplantation à la visite de randomisation.
    E.4Principal exclusion criteria
    Non-Inclusion criteria before HSCT :
    Patients with no affiliation to a social security scheme (beneficiary or legal)
    Pregnancy
    Asthma defined by reversibility with salbutamol (FEV1 > 12% or FEV1> 200ml)
    under inhaled corticosteroids or long acting beta agonists during the last three months
    Non-Randomisation criteria :
    - Viral respiratory infection (fever ≥ 38°C, tachypnea according to age, positive viral PCR pharyngeal aspiration) during the last month;
    - Lower respiratory tract infection (fever ≥ 38°C, tachypnea, radiologicaly or echography confirmed pneumonia, sputum) during the last month;
    - Invasive fungal disease (as defined by EORTC/MSG consensus group) during the last month.
    - Potent cytochrome P450 3A4 inhibitors, such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nilfinavir and nefazodone.
    - Corticosteroids or bronchodilatators inhaled treatment after transplantation
    - BOS
    Critères de non-inclusion avant HSCT :
    Patients non affiliés à un régime de sécurité sociale (bénéficiaire ou légal)
    Grossesse
    Asthme défini par la réversibilité avec le salbutamol (VEMS > 12 % ou VEMS > 200 ml)
    Patients sous corticostéroïdes par inhalation ou bêta-agoniste dans les trois mois qui précédent l’inclusion.
    Critères de non randomisation :
    - Infection respiratoire virale (fièvre ≥ 38°C, tachypnée en fonction de l’âge, aspiration pharyngée PCR virale positive) au cours du dernier mois ;
    - Infection des voies respiratoires inférieures (fièvre ≥ 38°C, tachypnée, pneumonie confirmée par radiologie ou échographie, crachat) au cours du dernier mois ;
    - Maladie fongique envahissante (telle que définie par le groupe de consensus EORTC/MSG) au cours du dernier mois.
    - Inhibiteurs puissants du cytochrome P450 3A4, comme le ritonavir, le kétoconazole, l'itraconazole, la troléandomycine, la clarithromycine, le nelfinavir, le nilfinavir et la néfazodone.
    - Corticostéroïdes ou bronchodilatateurs administrés par inhalation après transplantation
    - BO
    E.5 End points
    E.5.1Primary end point(s)
    The primary criterion will be the difference in the FEV1% predicted value from inclusion to 6 months following the initiation of treatment.
    Le critère principal sera la différence entre la valeur prévue du VEMS de 1 % à partir de l'inclusion jusqu'à 6 mois après le début du traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 Months
    6 mois
    E.5.2Secondary end point(s)
    1)Endpoints relative to respiratory symptoms :
    * dyspnea will be evaluate at the NYHA scoring;
    * step test (patient climb up and down step during three minutes at the frequency of 30/mn) : Respiratory rate, dyspnea Heart rate, SaO2 during the exercise.
    2) Endpoints relative to pulmonary function :
    * FEV1 (Forced expiratoy volume) VC (Vital Capacity) , TLC (Total Lung capacity) , RV (Residual volume), FRC (Functional Residual Capacity), sRaw (specific airway resistance) DLCO (diffusing capacity of the lungs) using a similar method of measurement for static lung volumes (plethysmography)

    * Number of patients presented with BOS defined as the absence of infection, and FEV1 < 75% predicted, and the FEV1/ FVC < 0.7, and the RV >120% or air trapping or bronchiectasies or small airways thyckening on computed tomography
    3) Endpoints relative to GVHD :
    * Acute and Chronic GVHD manifestations defined on NIH consensus with scoring;
    * First line of treatment: cumulative dose of corticosteroid systemic exposure and cumulative dose of calcineurins inhibitors.
    * Second line of GVHD treatment exposure will be assed using the other type of treatment.
    4) Endpoints relative to respiratory infections :
    - Number of adverse events.
    5) Endpoints relative to safety and tolerance:
    - Adverse events during the study period such as treatment tolerance, thrush, death.
    1) Paramètres relatifs aux symptômes respiratoires :
    * La dyspnée sera évaluée lors de la notation NYHA ;
    * test d'escalier (le patient monte et descend un escalier pendant trois minutes à la fréquence de 30 minutes) : Fréquence respiratoire, dyspnée Fréquence cardiaque, SaO2 pendant l'exercice.
    2) Paramètres relatifs à la fonction pulmonaire :
    * FEV1 (volume expiratoire forcé) VC (capacité vitale), TLC (capacité pulmonaire totale), RV (volume résiduel), FRC (capacité résiduelle fonctionnelle), sRaw (résistance spécifique des voies respiratoires) DLCO (capacité de diffusion des poumons) utilisant une méthode similaire de mesure des volumes respiratoires statiques (pléthysmographie)
    * Nombre de patients présentant un BO défini comme l'absence d'infection, et un VEMS < 75 % prédit, et un VEMS/ CVF < 0,7, et un VR > 120 % ou une rétention d'air ou des bronchiectasies ou un thyckening des petites voies respiratoires sur tomodensitomètre
    3) Paramètres relatifs à la GVHD :
    * Manifestations aiguës et chroniques de GVHD définies sur consensus NIH avec scoring ;
    * Première ligne de traitement : dose cumulative d'exposition systémique aux corticostéroïdes et dose cumulative d'inhibiteurs des calcineurines.
    * La deuxième ligne de traitement de l'exposition au GVHD sera évaluée à l'aide de l'autre type de traitement.
    4) Paramètres relatifs aux infections respiratoires :
    - Nombre d'événements indésirables.
    5) Paramètres relatifs à la sécurité et à la tolérance
    - Effets indésirables pendant la période à l'étude tels que la tolérance au traitement, le muguet, la mort
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 Months
    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 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned12
    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
    Dernière Visite Dernier Patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    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 Yes
    F.1.1Number of subjects for this age range: 243
    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.1.1.5.1Number of subjects for this age range: 120
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 123
    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 state243
    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)
    NONE
    AUCUN
    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 Decision2020-10-16
    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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