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    Summary
    EudraCT Number:2017-004872-76
    Sponsor's Protocol Code Number:RECUT-Trial
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-28
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-004872-76
    A.3Full title of the trial
    Reduction of corticosteroid use in outpatient treatment of
    exacerbated COPD – a randomized, double-blind, non-inferiority
    study (The “RECUT”-Trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    We want to investigate whether a three day treatment with orally administered systemic corticosteroids is non-inferior to a five day treatment in acute exacerbation of COPD managed in an outpatient setting and if total glucocorticoid exposure can be reduced by shorter therapy.
    A.3.2Name or abbreviated title of the trial where available
    Reduction of corticosteroid use in outpatient treatment of AECOPD - The “RECUT”-Trial
    A.4.1Sponsor's protocol code numberRECUT-Trial
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02386735
    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 SponsorMedizinische Universtitätsklinik, Kantonsspital Baselland
    B.1.3.4CountrySwitzerland
    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 supportMedizinische Universitätsklinik, Kantonsspital Baselland
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universitätsklinik, Kantonsspital Baselland
    B.5.2Functional name of contact pointReserach Associate; Kristin Abig
    B.5.3 Address:
    B.5.3.1Street AddressRheinstrasse 26
    B.5.3.2Town/ cityLiestal
    B.5.3.3Post code4410
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number++41619253754
    B.5.5Fax number++41619252883
    B.5.6E-mailkristin.abig@ksbl.ch
    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 Prednisone
    D.2.1.1.2Name of the Marketing Authorisation holderGalepharm AG, Küssnacht
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 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 INNPrednison
    D.3.9.1CAS number 53-03-2
    D.3.9.2Current sponsor codeH02AB07
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Prednisone
    D.2.1.1.2Name of the Marketing Authorisation holderGalepharm AG, Küssnacht
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 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 INNPrednisone
    D.3.9.1CAS number 53-03-2
    D.3.9.2Current sponsor codeH02AB07
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute exacerbation of COPD; acute exacerbation (defined solely by clinical parameters according
    to the Anthonisen criteria, meaning ≥2 of the following: change of baseline dyspnea, change of cough, change of
    sputum quantity or purulence) of their previously diagnosed COPD (irreversible obstruction with
    FEV1/FVC<70%)
    E.1.1.1Medical condition in easily understood language
    COPD is a type of obstructive lung disease characterized by long-term breathing problems and poor airflow. The main symptoms include shortness of breath and cough with sputum production.
    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 10010953
    E.1.2Term COPD exacerbation
    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 primary objective of this study is to investigate in an outpatient setting whether a three day treatment with
    orally administered systemic corticosteroids is non-inferior to a five day treatment in acute exacerbation of COPD.
    First endpoint will be time to next exacerbation during index exacerbation or a six months follow-up time.
    We postulate that in an outpatient setting, where generally less severe exacerbations are being treated, a three
    day treatment duration of systemic corticosteroids should be non-inferior to a five day treatment duration with
    regard to treatment benefits but decrease cumulative corticosteroid exposure.
    E.2.2Secondary objectives of the trial
    Secondary objective is to evaluate the two different corticosteroid treatment durations for differences in
    parameters other than re-exacerbation assessing effectiveness and safety. Parameters to be evaluated as
    secondary endpoints are: cumulative steroid dose, glucocorticoid side effects and complications, change in FEV1,
    clinical course assessed with the CAT-questionnaire, need for hospitalisation during index exacerbation and
    during follow-up time and death from any cause.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed Consent as documented by signature
    - Age ≥40 years
    - History of ≥10 pack-years of smoking (past or present smokers)
    - Airway obstruction, defined as FEV1/FVC≤70%
    - Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the
    following:
    o Change of baseline dyspnea
    o Change of cough
    o Change of sputum quantity or purulence
    E.4Principal exclusion criteria
    - Asthma/COPD overlap syndrome with a predominant Asthma component
    - Initial necessity of hospitalization
    - Women who are pregnant or breast feeding
    - Premenopausal women with insufficient contraception and anamnestic risk for pregnancy
    - Severe coexisting disease with life expectancy <6 months
    - Diagnosis of tuberculosis
    - Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation
    - Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia,
    etc. of the participant
    - Participation in another study involving an investigational drug
    - Previous enrolment into the current study
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome measured is time to next exacerbation during index exacerbation (treatment failure) or during a
    six months follow-up period (whichever occurs first). Exacerbation is defined as acute-onset worsening of the
    patient’s condition beyond day-to-day variations requiring interaction with a healthcare provider.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary outcome measured is time to next exacerbation during index exacerbation (treatment failure) or during a
    six months follow-up period (whichever occurs first).
    E.5.2Secondary end point(s)
    Secondary study outcomes are cumulative glucocorticoid dose, glucocorticoid side effects and complications,
    change in FEV1, hospitalization rate during index exacerbation and during follow-up time as well as clinical
    outcome assessed by the CAT and overall mortality.
    Cumulative glucocorticoid dose and glucocorticoid side effects are assessed to investigate safety of short-term
    and standard steroid treatment duration. Change in FEV1, hospitalization rate during index exacerbation and
    during follow-up time as well as clinical outcome and overall mortality are assessed to compare effectiveness of
    different durations of systemic corticosteroid treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during follow-up time
    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 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 Yes
    E.8.2.3.1Comparator description
    IMP 2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Austria
    Switzerland
    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
    last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 314
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 156
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 470
    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
    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 Decision2020-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
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