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    Summary
    EudraCT Number:2014-001029-34
    Sponsor's Protocol Code Number:2014-BUDFOR-EL-47
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-13
    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 number2014-001029-34
    A.3Full title of the trial
    Evaluation of the effect of the inhaled combination budesonide -formoterol (Pulmoton® Elpenhaler®) in exhaled nitric oxide (FeNO) of patients with bronchial asthma.
    Αξιολόγηση της επίδρασης του εισπνεόμενου συνδυασμού βουδεσονίδης-φορμοτερόλης (Pulmoton® Elpenhaler®) στο εκπνεόμενο μονοξείδιο του αζώτου (FeNO) ασθενών με βρογχικό άσθμα.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The inhaled combination of budesonide-formoterol consists a basic asthma treatment.
    A helpful specific index for the prognosis of future exacerbation risk and deterioration of lung function,is the Exhaled Nitric Oxide.

    The objective of the current study is the evaluation of Pulmoton- Elpenhaler in Exhaled Nitric Oxide of patients with bronchial asthma.
    Ο εισπνεόμενος συνδυασμός βουδεσονίδης-φορμοτερόλης αποτελεί τη βασική θεραπεία για το άσθμα.
    Ένας ειδικός δείκτης που βοηθά στην πρόγνωση μελλοντικού κινδύνου παρόξυνσης και μείωσης της λειτουργίας των πνευμόνων, είναι το εκπνεόμενο μονοξείδιο του αζώτου.

    Η παρούσα μελέτη έχει ως κύριο σκοπό την αξιολόγηση της επίδρασης του εισπνεόμενου συνδυασμού βουδεσονίδης-φορμοτερόλης (Pulmoton® Elpenhaler®) στο εκπνεόμενο μονοξείδιο του αζώτου ασθενών με βρογχικό άσθμα.
    A.3.2Name or abbreviated title of the trial where available
    Effect of Pulmoton Elpenhaler in FeNO of patients with bronchial asthma
    H επίδραση του Pulmoton Elpenhaler στη μέτρηση FeNO ασθενών με βρογχικό άσθμα
    A.4.1Sponsor's protocol code number2014-BUDFOR-EL-47
    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 SponsorELPEN Pharmaceutical Co. Inc
    B.1.3.4CountryGreece
    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 supportELPEN Pharmaceutical Co. Inc.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationELPEN Pharmaceutical Co. Inc.
    B.5.2Functional name of contact pointKaterina Vidanopoulou
    B.5.3 Address:
    B.5.3.1Street Address95, Marathonos Av.
    B.5.3.2Town/ cityPikermi, Attica
    B.5.3.3Post code19009
    B.5.3.4CountryGreece
    B.5.4Telephone number00302111865346
    B.5.5Fax number00302111865115
    B.5.6E-mailk.vidanopoulou@elpen.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 Pulmoton/Elpenhaler (200/6)mcg
    D.2.1.1.2Name of the Marketing Authorisation holderELPEN Pharmaceutical Co. Inc.
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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.3.1Product namePulmoton/Elpenhaler
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    Respiratory use (Noncurrent)
    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 Turbuhaler
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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.3.1Product nameSymbicort Turbuhaler
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    Respiratory use (Noncurrent)
    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
    Bronchial Asthma
    Bρογχικό Άσθμα
    E.1.1.1Medical condition in easily understood language
    Bronchial Asthma
    Bρογχικό Άσθμα
    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
    The primary objective of this study is the evaluation of the effect of inhaled combination of budesonide - formoterol (Pulmoton® Elpenhaler®) in exhaled nitric oxide (FeNO) of patients with bronchial asthma.
    Κύριος στόχος: Αξιολόγηση της επίδρασης του εισπνεόμενου συνδυασμού βουδεσονίδης-φορμοτερόλης (Pulmoton® Elpenhaler®) στο εκπνεόμενο μονοξείδιο του αζώτου (FeNO) ασθενών με βρογχικό άσθμα.

    E.2.2Secondary objectives of the trial
    Secondary objectives :
    - Comparison of the effect of Pulmoton® Elpenhaler® in FeNO, in patients with asthma, with the reference product Symbicort® Turbuhaler®.
    - Investigation of correlation between the existence of improvement ( reduction ) of FeNO with spirometry and the score of ACT questionnaire, by treatment group .
    - Collection of demographic data and safety .
    Δευτερεύοντες στόχοι:
    - Σύγκριση της επίδρασης του Pulmoton® Elpenhaler® στο FeNO ασθενών με άσθμα, με το προϊόν αναφοράς Symbicort® Turbuhaler®.
    - Διερεύνηση ύπαρξης συσχέτισης μεταξύ βελτίωσης (μείωσης) του FeNO με τη σπιρομέτρηση και τη βαθμολογία του ερωτηματολογίου ACT, ανά ομάδα θεραπείας.
    - Συλλογή δεδομένων δημογραφικών και ασφάλειας.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must meet all of the following criteria.
    1) Eligible ages for the study: 18-65 years
    2) Eligible for studying gender: Men and Women
    3) Non smokers
    4) History compatible with asthma and clinical diagnosis of asthma
    5) Improvement in FEV1> 12% and> 200ml in spirometry in bronchodilation test
    6) FeNO> 30ppb
    7) Patients who have fully understand the study protocol and signed the consent form
    8) Patients with asthma, who are not treated with ICS or montelukast for the last three months prior to entering the study
    9) Patients who are not treated corticosteroids for the last three months prior to entering the study
    1)Επιλέξιμες ηλικίες για τη μελέτη: 18-65 έτη
    2)Επιλέξιμο φύλο για τη μελέτη: Άνδρες και Γυναίκες
    3) Μη καπνιστές
    4)Ιστορικό συμβατό με άσθμα και κλινική διάγνωση άσθματος
    5)Βελτίωση FEV1>12% και >200ml στη σπιρομέτρηση κατά τη δοκιμασία βρογχοδιαστολής
    6)FeNO>30ppb
    7)Ασθενείς που έχουν κατανοήσει πλήρως το πρωτόκολλο της μελέτης και έχουν υπογράψει το έγγραφο συγκατάθεσης
    8)Ασθενείς που δεν λαμβάνουν θεραπεία άσθματος με ICS ή μοντελουκάστη τους τελευταίους 3 μήνες πριν την ένταξη
    9)Ασθενείς που δεν λαμβάνουν κορτικοστεροειδή τους τελευταίους 3 μήνες πριν την ένταξη.
    E.4Principal exclusion criteria
    1 ) Patients with hypersensitivity to budesonide, formoterol or lactose
    2 ) Patients , regardless of gender , age <18 years
    3 ) Patients with asthma,treated with montelukast or ICS for the last three months prior entering the study
    4 ) Patients being treated with corticosteroids fot the last three months prior entering the study
    5) Patients treated with potent CYP3A4 inhibitor
    6 ) Patients with severe cardiovascular disease or prolongation of QTc
    7) Patients with untreated hypokalaemia
    8) Patients with severe liver cirrhosis
    9) Patients with thyrotoxicosis , pheochromocytoma or diabetes
    10) Patients with other lung disease ( COPD, bronchiectasis , allergic rhinitis without treatment , etc . )
    11) Patients during asthma exacerbation
    12) Female patients who are pregnant , breastfeeding or planning to become pregnant
    13) Patients with known existing tumor or autoimmune disease known
    14) Patients with known psychiatric illness, or other condition which interferes with patient compliance to the procedures of the study
    15) Patients with respiratory infection the last 8 weeks
    16) Patients with severe asthma
    1)Ασθενείς με υπερευαισθησία στη βουδεσονίδη, στη φορμοτερόλη ή στη λακτόζη
    2)Ασθενείς, ανεξαρτήτως φύλου, ηλικίας < 18 ετών
    3)Ασθενείς που λαμβάνουν θεραπεία άσθματος με ICS ή μοντελουκάστη τους τελευταίους 3 μήνες πριν την ένταξη
    4)Ασθενείς που λαμβάνουν κορτικοστεροειδή τους τελευταίους 3 μήνες πριν την ένταξη.
    5)Ασθενείς σε θεραπεία με ισχυρό αναστολέα του CYP3A4
    6)Ασθενείς με σοβαρή καρδιαγγειακή νόσο ή επιμήκυνση του QTc
    7)Ασθενείς με μη αντιμετωπισθείσα υποκαλιαιμία
    8)Ασθενείς με σοβαρή κίρρωση του ήπατος
    9)Ασθενείς με θυρεοτοξίκωση, φαιοχρωμοκύτωμα ή σακχαρώδη διαβήτη
    10)Ασθενείς με άλλη πάθηση του αναπνευστικού (ΧΑΠ βρογχεκτασίες, αλλεργική ρινίτιδα χωρίς θεραπεία κλπ.)
    11)Ασθενείς κατά τη διάρκεια παροξυσμού άσθματος
    12)Γυναίκες ασθενείς που είναι έγκυες, θηλάζουν ή σκοπεύουν να μείνουν έγκυες
    13)Ασθενείς με γνωστή υφιστάμενη νεοπλασία ή γνωστό αυτοάνοσο νόσημα
    14)Ασθενείς με γνωστή ψυχιατρική συνδρομή, ή άλλη κατάσταση η οποία παρεμβαίνει με τη συμμόρφωση του ασθενούς στις διαδικασίες της μελέτης
    15)Ασθενείς με λοίμωξη του αναπνευστικού τις τελευταίες 8 εβδομάδες
    16)Ασθενείς με σοβαρό άσθμα
    E.5 End points
    E.5.1Primary end point(s)
    The change in the mean value of the exhaled nitric oxide (FeNO) between visits.The price will be expressed in parts per Billiard (ppb).
    All study sites will use the same type of analyzer NIOX® MINO and the recommendations of ATS for measuring FeNO,will be taken into consideration in order to exclude variations in the measurements.
    H μεταβολή της μέσης τιμής του εκπνεόμενου μονοξειδίου του αζώτου (FeNO) μεταξύ των επισκέψεων. Η τιμή θα εκφράζεται σε μέρη ανά δισεκατομύριο (ppb). Σε όλα τα κέντρα της μελέτης θα χρησιμοποιηθεί ο ίδιος τύπος αναλυτή NIOX® ΜΙNO και θα ληφθούν υπόψην οι συστάσεις της ATS για τη μέτρηση του FeNO, προκειμένου να αποκλειστούν διακυμάνσεις στις μετρήσεις τους.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline,4 weeks and 8 weeks
    αναφοράς, 4 εβδομάδες, 8 εβδομάδες
    E.5.2Secondary end point(s)
    Secondary variables of this study are:
    - The score of the ACT questionnaire , and
    - The FEV1 value recorded during the spirometry test.
    Δευτερεύουσες μεταβλητές της παρούσας μελέτης αποτελούν:
    - η βαθμολογία του ερωτηματολογίου ACT, και
    - η τιμή του FEV1 που καταγράφεται κατά τον σπιρομετρικό έλεγχο.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between visits
    Mεταξύ των επισκέψεων
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    πρωτότυπο SYMBICORT
    innovator SYMBICORT
    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 concerned4
    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
    June 2015 – Νοvember 2015
    Iούνιος 2015 – Νοέμβριος 2015
    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 months6
    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 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: 108
    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 state108
    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
    Κανένα
    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 Decision2015-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-30
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