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    Summary
    EudraCT Number:2020-001713-20
    Sponsor's Protocol Code Number:ASTHMAFAST
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-09-21
    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 number2020-001713-20
    A.3Full title of the trial
    Comparison of the efficacy and safety of budesonide/formoterol Turbuhaler® versus terbutaline nebulization as reliever therapy in children with asthma presenting at the emergency room for moderate exacerbation
    Comparaison de l’efficacité et de la sécurité du budenoside/formoterol Turbuhaler® par rapport à la terbutaline en nébulisation pour le traitement de la crise d’asthme chez les enfants se présentant aux urgences pour une exacerbation modérée
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of budesonide/formoterol versus terbutaline nebulization to treat children having an asthma attack
    Efficacité et sécurité du budenoside/formoterol par rapport à la terbutaline pour traiter les enfants ayant une crise d'asthme
    A.3.2Name or abbreviated title of the trial where available
    ASTHMAFAST
    A.4.1Sponsor's protocol code numberASTHMAFAST
    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 SponsorCentre Hospitalier Intercommunal de Créteil
    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 supportAstrazeneca
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Intercommunal de Créteil
    B.5.2Functional name of contact pointPr Ralph EPAUD
    B.5.3 Address:
    B.5.3.1Street Address40 avenue de Verdun
    B.5.3.2Town/ cityCRETEIL
    B.5.3.3Post code94000
    B.5.3.4CountryFrance
    B.5.4Telephone number33145175419
    B.5.6E-mailralph.epaud@chicreteil.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Bricanyl
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA
    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
    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 RoleComparator
    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 Symbicort
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA
    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 powder, pre-dispensed
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    moderate asthma exacerbation
    exacerbation modérée d'asthme
    E.1.1.1Medical condition in easily understood language
    asthma crisis
    crise d'asthme
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10049585
    E.1.2Term Infantile asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064823
    E.1.2Term Asthmatic crisis
    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
    To assess the efficacy of budesonide/formoterol Turbuhaler® reliever therapy versus terbutaline nebulization for moderate asthma exacerbation in paediatric emergency room.
    Evaluer l’efficacité de l’association Budesonide/formoterol Turbuhaler® comme traitement de secours versus terbutaline par nébulisation pour les exacerbations d’asthme modérées aux urgences pédiatriques.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of Budesonide/formoterol compared to terbutaline reliever therapy on:
    •Oxygen saturation
    •Hospitalization rate
    •Duration of stay in the ER
    •Improvement of asthma control (at one week and one month) and lung function (at one month)
    - To assess technical observance of Budesonide/formoterol Turbuhaler® reliever therapy in ER
    - To assess adverse events
    - Patient satisfaction
    - Medical staff satisfaction
    - Evaluer l’efficacité du budesonide/formoterol par rapport à la terbutaline comme traitement de secours sur :
    •La saturation transcutanée en oxygène (SpO2)
    •Le taux d’hospitalisations
    •La durée du séjour aux urgences
    • L’amélioration du contrôle de l’asthme (à une semaine et un mois) et de la fonction pulmonaire (à un mois)
    - Evaluer le bon usage du budesonside/formoterol Turbuhaler® aux urgences
    - Evaluer les effets indésirables
    - Evaluer la satisfaction du patient
    - Evaluer la satisfaction de l’équipe soignante en charge du patient
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Chidren 8-17 years
    - Children consulting to the ER with moderate asthma exacerbation (defined by the Pulmonary Score > 3 and ≤ 7)
    - Score for the inhalation technique = 3
    - French social security affiliation
    - Enfants de 8 à 17 ans
    - Enfants se présentant aux urgences pour exacerbation d’asthme modérée (définie par un score pulmonaire > 3 et ≤ 7)
    - Score pour la technique d’inhalation =3
    - Affiliation au régime de sécurité sociale français
    E.4Principal exclusion criteria
    - Pneumonia
    - Pulmonary and/or cardiac congenital malformations
    - Chronic pulmonary disease other than asthma (bronchopulmonary dysplasia, cystic fibrosis, or post infectious bronchiolitis obliterans)
    - Foreign body aspiration
    - Neurological alteration
    - Severe asthma exacerbation defined by Pulmonary Score > 7
    - Cardiopulmonary failure imminent or mechanical ventilation indication
    - Thyrotoxicosis, pheochromocytoma, type 2 diabetes, untreated hypokalemia, obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other serious cardiovascular disorders such as ischemic heart disease, tachyarrhythmias or severe heart failure.
    - Pregnancy
    - Breastfeeding woman
    - Ongoing Participation in RIPH1 Intervention Research
    - History of intolerance to terbutaline
    - Hypersensitivity to the active ingredient or one of the excipients of terbutaline
    - Hypersensitivity (allergy) to budesonide, formoterol or any component of the product (lactose may contain milk proteins in small quantities)
    - Patient with an ongoing treatment of itraconazole, ritonavir or other potent CYP3A4 inhibitor, quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors (MAOIs), beta-blockers (including eyedrops) and tricyclic antidepressants
    - Pneumonie
    - Malformations congénitales pulmonaire et/ou cardiaque
    - Maladie pulmonaire chronique autre que l’asthme (dysplasie broncho-pulmonaire, mucoviscidose, ou de bronchiolite post-infectieuse oblitérante)
    - Inhalation d’un corps étranger
    - Altération neurologique
    - Exacerbation d’asthme sévère définie par un score pulmonaire > 7
    - Défaillance cardiopulmonaire imminente ou indication de ventilation mécanique
    - Thyrotoxicose, phéochromocytome, diabète de type 2, hypokaliémie non traitée, cardiomyopathie obstructive, sténose idiopathique de l'aorte sous-valvulaire, hypertension sévère, anévrisme ou autres troubles cardiovasculaires graves tels que cardiopathie ischémique, tachyarythmie ou insuffisance cardiaque sévère
    - Grossesse
    - Femme allaitante
    - Participation en cours à une recherche de type RIPH1
    - Antécédent d’intolérance à la terbutaline
    - Hypersensibilité à l’un des principes actifs ou à l’un des excipients de la terbutaline
    - Hypersensibilité (allergie) au budenoside, formoterol ou tout composant du produit (le lactose peut contenir des protéines de lait en petite quantité)
    - Patient ayant un traitement en cours d'itraconazole, ritonavir ou autre inhibiteur puissant du CYP3A4, quinidine, disopyramide, procaïnamide, phénothiazines, antihistaminiques (terfénadine), inhibiteurs de la monoamine oxydase (IMAO) et antidépresseurs tricycliques
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of success defines by a pulmonary score < 3
    Pourcentage de succès défini par un score pulmonaire < 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the administration of the treatment
    A l'issu de l’administration du traitement quelque soit le bras
    E.5.2Secondary end point(s)
    - Number of hospitalized patients
    - Number of hours of stay in the ER
    - Score for the inhalation technique at each procedure
    - Score on the Asthma Control Test (ACT)
    - Number of medical visits at 1 week following the exacerbation
    - Number of medical visits at 1 month following the exacerbation
    - Number of patients with a controlled asthma at 1 month following the exacerbation
    - Number of adverse events
    - Forced expiratory volume in one second (FEV1) before bronchodilalator at 1 month
    - Forced expiratory volume in one second (FEV1) after bronchodilalator at 1 month
    - Forced vital capacity (FVC) before bronchodilalator at 1 month
    - Forced vital capacity (FVC) after bronchodilalator at 1 month
    - Total pulmonary capacity (TPC) before bronchodilalator at 1 month
    - Total pulmonary capacity (TPC) after bronchodilalator at 1 month
    - Vital capacity (VC) before bronchodilalator at 1 month
    - Vital capacity (VC) after bronchodilalator at 1 month
    - FEV1/VC before bronchodilalator at 1 month
    - FEV1/VC after bronchodilalator at 1 month

    For budenoside/formoterol group only
    - SaO2 (%) at baseline and 5 minutes after each procedure
    - Pulmonary score at baseline and 5 minutes after each procedure
    - Respiratory rate at baseline and 5 minutes after each procedure
    - Nombre de patients hospitalisés
    - Durée du séjour en heures aux urgences
    - Score de la technique d’inhalation après chaque inhalation
    - Score de contrôle de l’asthme via le questionnaire ACT
    - Nombre de visites médicales à 1 semaine de l’exacerbation
    - Nombre de visites médicales à 1 mois de l’exacerbation
    - Nombre de patients avec un asthme contrôlé à 1 mois suivant l’exacerbation
    - Nombre d’évènements indésirables
    - Volume expiratoire forcé en 1 seconde (VEMS) avant bronchodilatateur à un mois
    - Volume expiratoire forcé en 1 seconde (VEMS) après bronchodilatateur à un mois
    - Capacité vitale forcée (CVF) avant bronchodilatateur à 1 mois
    - Capacité vitale forcée (CVF) après bronchodilatateur à 1 mois
    - Capacité pulmonaire totale avant bronchodilatateur à 1 mois
    - Capacité pulmonaire totale après bronchodilatateur à 1 mois
    - Capacité vitale (CV) avant bronchodilatateur à 1 mois
    - Capacité vitale (CV) après bronchodilatateur à 1 mois
    - VEMS/CV avant bronchodilatateur à 1 mois
    - VEMS/CV après bronchodilatateur à 1 mois
    Pour le groupe budenoside/formoterol uniquement :
    - SpO2 (%) initiale et 5 minutes après chaque procédure
    - Score pulmonaire initial et 5 minutes après chaque procédure
    - Fréquence respiratoire initiale et 5 minutes après chaque procédure
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 5 minutes after each treatment procedure
    - 30 minutes after the last treatment administration
    - at 1 week
    - at 1 month
    - 5 minutes après chaque procédure de traitement
    - 30 minutes après la dernière administration de traitement
    - à une semaine
    - à 1 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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Terbutaline
    E.8.2.4Number of treatment arms in the trial2
    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 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 du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 102
    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: 51
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 51
    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 Yes
    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 Yes
    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 state102
    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 Decision2019-11-26
    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 StatusPrematurely Ended
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