Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-000495-28
    Sponsor's Protocol Code Number:132
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-30
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-000495-28
    A.3Full title of the trial
    SIGNATURE - the 6-gene signature as a predictor of response to treatment in severe asthma and ACOS
    Anvendelse af 6-gen signaturen til at forudsige behandlingseffekt ved svær astma og astma-KOL overlap sygdom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SIGNATURE - The use of gene profiling to predict treatment response in severe asthma and in obstructive lung disease with elements of both astma and COPD
    SIGNATURE - Brugen af gen-udtryk til at forudsige behandlingseffekt ved svær astma og sygdom med komponenter af både astma og KOL
    A.4.1Sponsor's protocol code number132
    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 SponsorRespiratory Research Unit, Bispebjerg University Hospital
    B.1.3.4CountryDenmark
    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 supportRespiratory Research Unit, Bispebjerg University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRespiratory Research Unit, Bispebjerg University Hospital
    B.5.2Functional name of contact pointCeleste Porsbjerg
    B.5.3 Address:
    B.5.3.1Street AddressBispebjerg Bakke 23
    B.5.3.2Town/ cityCopenhagen NV
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.6E-mailceleste.porsbjerg@regionh.dk
    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 Prednisolon DAK
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 namePrednisolon
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolon
    D.3.9.1CAS number 53-03-2
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Severe asthma and astma-COPD overlap syndrome
    svær astma og astma-KOL overlap sygdom
    E.1.1.1Medical condition in easily understood language
    Asthma requiring high dose of inhaled treatment and obstructive lung disease with elements of both asthma and COPD
    Astma der kræver høj dosis af inhalationsbehandling samt obstruktiv lungesygdom med elementer af både astma og KOL
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077006
    E.1.2Term Asthma-COPD overlap syndrome
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003561
    E.1.2Term Asthma, unspecified
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068462
    E.1.2Term Eosinophilic asthma
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to develop a tool able to predict response to oral corticosteroids in patients with severe asthma or ACOS using the 6-gene signature as well as
    Det primære formål med studiet er at udvikle et værktøj, der kan forudsige behandlingsrespons på orale kortikosteroider hos patienter med svær astma eller astma-KOL-overlap sygdom.
    E.2.2Secondary objectives of the trial
    The secondary objective of the trial is to assess the impact of smoking in patients with severe eosinophilic asthma, with regards to cell composition in blood and sputum and the impact of smoking on treatment response and change in cell composition after treatment.
    Det sekundære formål med studiet er at undersøge effekten af rygning hos patienter med svær eosinofil astma i forhold til cellesammensætningen i blod og sputum samt effekten af rygning på behandlingsrespons og ændringen i cellesammensætningen efter endt behandling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ≥18 years old.
    - Signed informed consent.

    Subjects must fulfill one of the following;
    - Severe asthma as classified by ≥1 of following:
     * Maintenance therapy with ICS equivalent to ≥1600µg of budesonide daily AND a second controller (LABA, LTRA, or xanthines).
     * OCS for 50% or more days in the previous year .
    OR

    - ACOS (as classified as ≥1 of BOTH the asthma and COPD features listed.)
     COPD-features:
    • FEV1/FVC ratio < 0,7
    • A Smoking history equivalent to ≥10 pack years

    Asthma features:
    • Bronchodilator reversibility
    • Blood eosinophilia
    • Sputum eosinophilia (- ACOS (as classified as ≥1 of BOTH the asthma and COPD features listed.)
     COPD-features:
    • FEV1/FVC ratio < 0,7
    • A Smoking history equivalent to ≥10 pack years

    Asthma features:
    • Bronchodilator reversibility (over 12% reversible)
    • Blood eosinophilia (≥250 eosinophils/µL)
    • Sputum eosinophilia (≥3% eosinophils in sputum)
    • History of atopy
    • Onset of disease before the age of 25
    • History with a positive bronchial provocation test (methacholine or mannitol)



    Alder ≥ 18 år.
    Underskrevet informeret samtykke.

    Et af følgende to kriterier:

    - Svær astma, defineret som ≥1 adf følgende:
    * Vedligeholdelsesterapi med ICS svarende til ≥1600µg budesonid dagligt PLUS en second controller (LABA, LTRA eller xanthiner)
    * OCS i 50% eller mere af tiden det seneste år.
    ELLER

    - ACOS (defineret som ≥1 of BÅDE astma OG KOL-elementerne herunder):
     KOL-elementer:
    • FEV1/FVC ratio < 0,7
    • Rygehistorie med ≥ 10 pakkeår

    Astma-elementer:
    • Bronkodilator reversibilitet (over 12% reversibel)
    • Blod eosinofili (≥250 eosinofile/µL)
    • Sputum eosinofili (over 3 %)
    • Atopi
    • Sygdomsdebut før 25-års-alder
    • Historisk positiv bronkial provokationstest (metakolin eller mannitol)
    E.4Principal exclusion criteria
    - Current daily OCS treatment.
    - Pregnancy.
    - Change in ICS maintenance therapy in the preceding 4 weeks.
    - Recent exacerbation defined as ≥1 in the preceding 4 weeks:
    * Antibiotics due to airway infection.
    * Hospitalization due to airway infection.
    * OCS due to worsening of disease control.
    - If the subject is unable to understand written information and thus fill out questionnaires due to languages barriers.
    - Permanently incapable patients
    - Confirmed concurrent airway disease.
    - Other serious systemic and/or autoimmune disease
    * ASA 3 or worse or by investigator determination
    - Subjects who, by investigator determination, will not be able to adhere to the study protocol
    Aktuel fast behandling med OCS.
    - Graviditet.
    - Ændring i ICS vedligholdelsesterapi de seneste 4 uger.
    - Nylig exacerbation defineret som ≥1 af følgende de seneste 4 uger:
    * Antibiotika som følge af luftvejsinfektion.
    * Indlæggelse som følge af luftvejsinfektion.
    * OCS som følge af forværring af symptomer/tab af kontrol.
    - Patienter ude af stand til at forstå skreven information eller udfylde spørgeskemaer grundet sprogbarrierer.
    - Inhabile patienter
    - Bekræftet anden betyndende lungesygdom
    - Anden betydende/alvorlig systemisk sygdom
    * ASA 3 eller værre eller efter investigators skøn
    - Patienter, der ud fra investigators skøn ikke vil være i stand til at gennemføre forsøget.
    E.5 End points
    E.5.1Primary end point(s)
    Lung function:
    o Change in FEV1 after intervention
    Ændring i lungefunktion (FEV1) efter intervention
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before intervention (day 1) and after intervention (day 15)
    Før intervention (dag 1) og efter intervention (dag 15)
    E.5.2Secondary end point(s)
    Change in:
    o Symptom score: ACQ, MRC
    o Quality of life: miniAQLQ
    o Airway reactivity to mannitol
    o Induced sputum (differential count and gene expression profile)
    o FeNO in exhalation
    o Blood test (differential count, IgE)
    o Concentration of specific immune cells (ILCs) and cytokines in sputum and blood
    Ændring i:
    o Symptom score: ACQ, MRC
    o Quality of life: miniAQLQ
    o Luftvejsreaktion på mannitol
    o Induceret sputum (differentialtælling og genekspressionsprofil)
    o FeNO i udåndingsluft
    o Blodprøver (differentialtælling, IgE)
    o Koncentration af specifikke immunceller (ILC'er) og cytokiner i sputum og blod
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before intervention (day 1) and after intervention (day 15)
    Før intervention (dag 1) og efter intervention (dag 15)
    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 No
    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 No
    E.8.1.1Randomised No
    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 No
    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
    Sidste besøg for sidste forsøgsperson
    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 months0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 Yes
    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 state125
    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
    Ingen
    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 Decision2017-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-30
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 16:09:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA