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    The EU Clinical Trials Register currently displays   38177   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001306-35
    Sponsor's Protocol Code Number:APHP200394
    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:2020-03-27
    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 number2020-001306-35
    A.3Full title of the trial
    Protective role of inhaled steroids for COVID-19 infection
    Rôle protecteur des stéroïdes inhalés pour l'infection par COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Protective role of inhaled steroids for COVID-19 infection
    Rôle protecteur des stéroïdes inhalés pour l'infection par COVID-19
    A.3.2Name or abbreviated title of the trial where available
    INHASCO
    INHASCO
    A.4.1Sponsor's protocol code numberAPHP200394
    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 SponsorDRCI APHP
    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 supportDRCI APHP
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRCI APHP
    B.5.2Functional name of contact pointVANHOYE
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.4CountryFrance
    B.5.6E-maildamien.vanhoye@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 SYMBICORT RAPIHALER 200/6 μg par dose, suspension pour inhalation en flacon pressurisé
    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 solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROL
    D.3.9.1CAS number 73573-87-2
    D.3.9.4EV Substance CodeSUB07788MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only.
    Comparer le temps à l'amélioration clinique chez les patients recevant la norme de soins associée à la combinaison budésonide/formotérol ou à la norme de soins uniquement.
    E.2.2Secondary objectives of the trial
    To compare in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only the :
    - Mortality
    - Percentage admitted to ICU
    - Percentage requiring invasive or non-invasive ventilation
    - Duration of oxygen therapy
    - Duration of hospital stay
    - Number of co-infections
    - Systemic inflammation
    - Treatment tolerance.
    Pour comparer, chez les patients recevant des soins de qualité associés à la combinaison budésonide/formotérol ou à la qualité des soins, seul le :
    - Mortalité
    - Pourcentage admis à l'USI
    - Pourcentage nécessitant une ventilation invasive ou non invasive
    - Durée de l'oxygénothérapie
    - Durée du séjour à l'hôpital
    - Nombre de co-infections
    - Inflammation systémique
    - Tolérance au traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient ≥ 18 years old
    - Laboratory proved infection by COVID-19 within 2 days
    - Hospitalization is required (based on investigator judgement)
    - Patient affiliated to a social security regime
    - Patient able to give free, informed and written consent
    - Patient ≥ 18 ans
    - Le laboratoire a prouvé l'infection par COVID-19 dans les 2 jours
    - Une hospitalisation est nécessaire (sur la base du jugement de l'enquêteur)
    - Patient affilié à un régime de sécurité sociale
    - Le patient peut donner son consentement libre, éclairé et écrit
    E.4Principal exclusion criteria
    - Current treatment with any inhaled steroid
    (any other form of steroid administration does not exclude the patient)
    - Intensive care unit is required for the patient
    (based on investigator judgement)
    - Patient with cognitive impairment which do not guarantee proper use of the treatment by the patient himself
    - Pregnant or breastfeeding women
    - Participation in another interventional drug study involving human participants and concerning COVID-19 infection or being in the exclusion period of a previous study involving human participants
    - Contraindications to the treatments
    - Not to be resuscitated decision (co-morbidity, …)
    - Traitement actuel avec tout stéroïde inhalé
    (toute autre forme d'administration de stéroïdes n'exclut pas le patient)
    - Une unité de soins intensifs est nécessaire pour le patient
    (sur la base du jugement de l'enquêteur)
    - Patient présentant une déficience cognitive qui ne garantit pas une utilisation correcte du traitement par le patient lui-même
    - Femmes enceintes ou qui allaitent
    - Participation à une autre étude interventionnelle sur les médicaments impliquant des participants humains et concernant l'infection par COVID-19 ou être dans la période d'exclusion d'une étude précédente impliquant des participants humains
    - Contre-indications aux traitements
    - Décision de ne pas être réanimé (co-morbidité, ...)
    E.5 End points
    E.5.1Primary end point(s)
    Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.
    Le temps (en jours) jusqu'à l'amélioration clinique est défini comme le temps écoulé entre la randomisation et une amélioration de deux points (par rapport au statut au moment de la randomisation) sur une échelle ordinale à sept catégories ou une sortie vivante de l'hôpital, selon ce qui s'est produit en premier dans les 30 jours
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    30 jours
    E.5.2Secondary end point(s)
    Secondary Objectives and Endpoints :
    To compare in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only the :
    - Mortality
    - Percentage admitted to ICU
    - Percentage requiring invasive or non-invasive ventilation
    - Duration of oxygen therapy
    - Duration of hospital stay
    - Number of co-infections
    - Systemic inflammation
    - Treatment tolerance.

    Secondary Endpoints :
    - Mortality rate at D30
    - Time (in days) from randomization to death
    - Number of days alive outside ICU within 30 days
    - Number of days alive free of invasive or non invasive ventilation within 30 days
    - Number of days alive with oxygen therapy within 30 days
    - Maximal oxygen rate within 30 days
    - PaO2/FiO2 ratio at randomization and at Day 7 (or at the time of stopping oxygen therapy or discharge if occurs before Day 7)
    - Number of days alive outside hospital within 30 days Use of antibiotics for respiratory (proved or suspected) infection within 30 days
    - CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)
    - Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.
    Comparer chez les patients recevant des soins de qualité associés à la combinaison budésonide/formotérol ou à la qualité des soins uniquement le :
    - Mortalité
    - Pourcentage admis à l'USI
    - Pourcentage nécessitant une ventilation invasive ou non invasive
    - Durée de l'oxygénothérapie
    - Durée du séjour à l'hôpital
    - Nombre de co-infections
    - Inflammation systémique
    - Tolérance au traitement.

    Paramètres secondaires :
    - Taux de mortalité à J30
    - Temps (en jours) entre la randomisation et la mort
    - Nombre de jours de vie en dehors de l'USI dans les 30 jours
    - Nombre de jours de vie sans ventilation invasive ou non invasive dans les 30 jours
    - Nombre de jours de vie avec l'oxygénothérapie dans les 30 jours
    - Taux d'oxygène maximal dans les 30 jours
    - Rapport PaO2/FiO2 au moment de la randomisation et au jour 7 (ou au moment de l'arrêt de l'oxygénothérapie ou de la décharge si elle a lieu avant le jour 7)
    - Nombre de jours de vie en dehors de l'hôpital dans les 30 jours Utilisation d'antibiotiques pour une infection respiratoire (avérée ou suspectée) dans les 30 jours
    - Niveaux de CRP au hasard et au jour 7 (ou au moment de la décharge si elle a lieu avant le jour 7)
    - Les résultats en matière de sécurité comprenaient les événements survenus pendant le traitement, les effets indésirables graves et l'arrêt prématuré du traitement.

    E.5.2.1Timepoint(s) of evaluation of this end point
    cf below
    cf au dessus
    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) 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard of care
    standard of care
    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
    If hospital discharge is proposed before end of the study, phone call will be performed by the investigator’s team at D30. This phone call will permit to get informations about potential re-hospitalization and the occurrence of serious adverse event.

    At the end of the study, if the patient is still hospitalized, he will receive care in accordance with current service practice.
    Si une sortie de l'hôpital est proposée avant la fin de l'étude, l'appel téléphonique sera effectué par l'équipe de l'investigateur à J30. Cet appel téléphonique permettra d'obtenir des informations sur une éventuelle ré-hospitalisation et sur la survenue d'un événement indésirable grave.

    À la fin de l'étude, si le patient est toujours hospitalisé, il recevra des soins conformément aux pratiques actuelles du service.
    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 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.1.2.1Number of subjects for this age range: 436
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 436
    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 state
    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)
    At the end of the study, if the patient is still hospitalized, he will receive care in accordance with current service practice.
    À la fin de l'étude, si le patient est toujours hospitalisé, il recevra des soins conformément aux pratiques actuelles du service.
    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 Decision2020-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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