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    The EU Clinical Trials Register currently displays   36125   clinical trials with a EudraCT protocol, of which   5941   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-012203-26
    Sponsor's Protocol Code Number:Grand_Award_Health-F5_2009-223060
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-08
    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 ConcernedGreece - EOF
    A.2EudraCT number2009-012203-26
    A.3Full title of the trial
    Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
    Αποτελεσματικότητα και Ασφάλεια της Εισπνεόμενης Βουδεσονίδης σε Πολύ Πρόωρα Βρέφη σε Κίνδυνο για Βρογχοπνευμονική Δυσπλασία
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neonatal European Study of Inhaled Steroids
    Νεογνολογική Ευρωπαϊκή Μελέτη Εισπνεόμενων Στεροειδών
    A.3.2Name or abbreviated title of the trial where available
    NEuroSIS
    Νεογνολογική Ευρωπαϊκή Μελέτη Εισπνεόμενων Στεροειδών
    A.4.1Sponsor's protocol code numberGrand_Award_Health-F5_2009-223060
    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 SponsorUniversity Children's Hospital, Department of Neonatology
    B.1.3.4CountryGermany
    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 supportEuropean Commission, Seven Framework Programme (7FP)
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAristotle University of Thessaloniki, Research Committee, Programme Beneficiary No. 11
    B.5.2Functional name of contact pointGeorgia Petridou
    B.5.3 Address:
    B.5.3.1Street AddressAdministration Building, University Campus
    B.5.3.2Town/ cityThessaloniki
    B.5.3.3Post code54124
    B.5.3.4CountryGreece
    B.5.4Telephone number00302310998428
    B.5.5Fax number00302310853283
    B.5.6E-mailmarketing@rc.auth.gr
    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 Budiair
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi 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.3.4Pharmaceutical form Pressurised 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.3.11 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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic, non-halogenated corticosteroid for topic inhalation use only
    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 vapour, 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
    Risk of Bronchopulmonary Dysplasia at Very Preterm Infants
    Κίνδυνος εμφάνισης Βρογχοπνευμονικής Δυσπλασίας σε πολύ πρόωρα βρέφη
    E.1.1.1Medical condition in easily understood language
    BPD is a chronic lung disease that occurs in premature infants requiring mechanical ventilation and oxygen therapy.
    Η BPD είναι μια χρόνια πάθηση των αεραγωγών που συμβαίνει στα πρόωρα βρέφη για τα οποία απαιτείται μηχανισμός αερισμός και θεραπεία με οξυγόνο.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10006475
    E.1.2Term Bronchopulmonary dysplasia
    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 determine if the early (within 12 hours of life) prophylactic use of inhaled corticosteroids 9Budesonide) in very preterm infants (gestational age 23 0/7 - 27 6/7 weeks requiring any form of positive pressure support (mechanical or nasal ventilation or CPAP increases survival without BPD at 36 weeks gestational age
    Να προσδιοριστεί ένα η πρώιμη (εντός των 12 ωρών ζωής) προφυλακτική χρήση των εισπνεόμενων κορτικοστεροειδών (Βουδεσονίδη) σε πολύ πρόωρα βρέφη (ηλικία κύησης 23 0/7 – 27 6/7 εβδομάδες) απαιτώντας την οποιανδήποτε μορφή υποστήριξης θετικής πίεσης (μηχανικός ή ρινικός αερισμός ή συνεχής θετική πίεση αεραγωγών (CPAP) αυξάνει την επιβίωση χωρίς βρογχοπνευμονική δυσπλασία (BPD) στην ηλικία κύησης των 36 εβδομάδων
    E.2.2Secondary objectives of the trial
    To determine whether early inhalation of corticosteroids for the prevention of BPD alters the incidence of infants born prematurely with neurodevelopmental impairment at a corrected age of 18 to 22 months. To determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks gestational age, BPD incidence at 36 gestational ages, and the duration of positive pressure respiratory support or supplemental oxygen
    Να προσδιοριστεί του κατά πόσο η πρώιμη εισπνοή κορτικοστεροειδών για την πρόληψη της BPD αλλοιώνει την επίπτωση των βρεφών που γεννιούνται πρόωρα με νευροαναπτυξιακή εξασθένιση στην διορθωμένη ηλικία 18 έως 22 μηνών.
    Να προσδιοριστεί του κατά πόσο η εισπνοή κορτικοστεροειδών συσχετίζεται με ανεπίστρεπτες επιδράσεις της αγωγής, αλλοιώνει την θνητότητα στην ηλικία κύησης των 36 εβδομάδων, την επίπτωση της BPD στην ηλικία κύησης των 36 εβδομάδων και την χρονική διάρκεια της αναπνευστικής υποστήριξης θετικής πίεσης ή του συμπληρωματικού οξυγόνου.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A gestational age of 23 0/7 - 27 6/7 weeks, a postnatal age < 12 hours, the requirement for any form of positive pressure support (mechanical or nasal ventilation or CPAP) and parental consent for participation
    Ηλικία κύησης 23 0/7 – 27 6/7 εβδομάδων, μεταγεννητική ηλικία < 12 ωρών
    Η απαίτηση για οποιαδήποτε μορφή υποστήριξης θετικής πίεσης (μηχανικός ή ρινικός αερισμός ή CPAP) και η γονική συναίνεση για συμμετοχή
    E.4Principal exclusion criteria
    A clinical decision not to administer therapies (infant not considered viable), dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment and known or suspected congenital heart disease (not including a persistent ductus arteriosus and/or atrium septum defect). The clinical assessment of dysmorphic features, congenital malformations, suspected congenital heart disease and the decision to exclude an infant for the above mentioned reasons will be left to the discretion of the attending physician.
    Κλινική απόφαση να μην χορηγηθούν θεραπείες (το βρέφος δεν θεωρείται βιώσιμο), δυσμορφικά χαρακτηριστικά ή συγγενείς παραμορφώσεις που επηρεάζουν ανεπίστρεπτα το προσδόκιμο ζωής ή τν νευροανάπτυξη και γνωστή ή ύποπτη συγγενής καρδιακή πάθηση (μη συμπεριλαμβανομένου του εμμένοντος αρτηριακού πόρου και/ή του ελλείμματος κολπικού διαφράγματος). Η κλινική εκτίμηση των δυσμορφικών χαρακτηριστικών, των συγγενών παραμορφώσεων, της συγγενούς καρδιακής πάθησης και η απόφαση να αποκλειστεί ένα βρέφος για τους προαναφερόμενους λόγους θα αφεθεί στην διακριτική ευχέρεια του θεράποντος και παρακολουθούντος ιατρού.
    E.5 End points
    E.5.1Primary end point(s)
    The parameter for the confirmatory analysis of efficacy will be the incidence of primary endpoints. A primary endpoint is defined as the occurrence of any of the following events during the first 36 weeks of gestational age: (1) death for any reason until the end of week 36 gestational age, (2) BPD according to the physiological condition, diagnosed at 36 weeks +/- 1 day gestational age.
    Η παράμετρος για την επιβεβαιωτική ανάλυση της αποτελεσματικότητας θα είναι η επίπτωση των πρωτευόντων τελικών σημείων. Ένα πρωτεύον τελικό σημείο ορίζεται ως η εμφάνιση του οποιοδήποτε εκ των ακόλουθων συμβαμάτων κατά την διάρκεια των πρώτων 36 εβδομάδων της ηλικίας κύησης: (1) Θάνατος για τον οποιονδήποτε λόγο μέχρι το πέρας της ηλικίας κύησης των 36 εβδομάδων, (2) BPD σύμφωνα με τον φυσιολογικό ορισμό, που διαγιγνώσκεται στην ηλικία κύησης των 36 εβδομάδων +/- 1 ημέρα.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Yes
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial4
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Finland
    France
    Germany
    Italy
    Netherlands
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 50
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 50
    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) 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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Very preterm infants (23 0/7 - 27 6/7 gestational age)
    Πολύ πρόωρα βρέφη (ηλικίας κύησης 23 0/7 - 27 6/7)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 850
    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)
    According to the Standard of Care for the management of very preterm infants at NICU's and in conformity with Guidelines/Guidance of the Hellenic Neonatology Association
    Σύμφωνα με την τυπική, καθημερινή ιατρική πρακτική για την αντιμετώπιση πολύ πρόωρων βρεφών σε ΜΕΝΝ (Μονάδες Εντατικής Νοσηλείας Νεογνών) και σύμφωνα με τις Κατευθυντήριες Γραμμές/Οδηγίες της Ελληνικής Νεογνολογικής Εταιρείας
    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 Decision2012-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-19
    P. End of Trial
    P.End of Trial StatusOngoing
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