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    Summary
    EudraCT Number:2015-003441-26
    Sponsor's Protocol Code Number:Protocol_CORTICO-COP_PSJUJ
    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:2015-09-14
    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 number2015-003441-26
    A.3Full title of the trial
    CORTICO-COP (CORTICOsteroid reduction in COPD) trial
    Klinisk forsøg vedrørende effekten af reduceret kortikosteroid-behandling til patienter med KOL i forværring
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of reduced corticosteroid therapy in patients with acute exacerbation of COPD
    A.3.2Name or abbreviated title of the trial where available
    CORTICO-COP
    A.4.1Sponsor's protocol code numberProtocol_CORTICO-COP_PSJUJ
    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 SponsorChronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    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 No
    D.2.1.1.1Trade name Prednisolon
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S and Alternova 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 Coated 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 INNPREDNISOLONE
    D.3.9.2Current sponsor codeprednisolone
    D.3.9.3Other descriptive namePREDNISOLONE
    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 number37,5 to 37.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    1) Whether a reduction of the dose systemic corticosteroids (SC) therapy in patients with acute exacerbation of COPD(AE-COPD) - compared with AE-COPD patients in the standard treatment- leading to non-inferiority 2)Whether there is a difference in treatment response in AE-COPD patients with eosinophilic airway inflammation compared to AE-COPD patients with non-eosinophilic airway inflammation 3) whether a lower accumulated dose SC may be associated with fewer corticosteroid adverse events
    E.1.1.1Medical condition in easily understood language
    Individualisation of corticosteroid therapy for AECOPD patients
    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 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 purpose is to examine whether we can reduce the accumulated corticosteroid therapy to the individual COPD patient with the aim of reducing the number of corticosteroid-related adverse events.
    E.2.2Secondary objectives of the trial
    Is there a difference in treatment response in AE-COPD patients with
    eosinophilic airway inflammation and AE-COPD patients with predominantly non-eosinophilic airway inflammation
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In a nationwide epidemiological study to examine whether systemic corticosteroid therapy is an independent predictor of corticosteroid-induced side effects (<12 months after prednisolone). Stratifying for age, inhaled corticosteroid and lung function (multivariate regression analysis). Endpoints: pneumonia requiring hospitalization, diabetes requiring hospitalization, GI hemorrhage, osteoporosis diagnosis (= Bisphosphonate / Prolia therapy <12 months).
    E.3Principal inclusion criteria
    1) Patients hospitalized with COPD exacerbation
    2) Age ≥ 40 years
    3) Spirometry-verified COPD (defined as FEV1 / FVC ≤ 70%)
    4) GOLD class C or D
    5) Inclusion within 24 hours after admission
    E.4Principal exclusion criteria
    1) Known with a diagnosis of asthma
    2) Life expectancy less than 30 days
    3) Serious exacerbation requiring invasive ventilation or admission to ICU
    4) Allergy to systemic corticosteroids
    5) Severe mental illness, which is not controlled by medication
    6) People who are detained under the act on the use of coercion in psychiatry
    7) Severe language problems or inability to provide written informed consent
    8) Pregnancy and lactation
    9) Systemic fungal infections
    E.5 End points
    E.5.1Primary end point(s)
    1) Days alive and out of hospital within 14 days after recruitment
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days
    E.5.2Secondary end point(s)
    1) Treatment failure (Recurrence of COPD exacerbation resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days)
    2) Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month follow-up
    3) Mortality rate 360 days
    4) infection requiring antibiotic treatment within 180 days after the index AECOPD exacerbation
    5) The period between index AECOPD and the next AECOPD exacerbation
    a. Readmission with AECOPD or death
    b. Time to readmission with AECOPD or death
    6) Cumulative corticosteroid dose at 1 and 3 months follow-up
    a. Proportions of patients using corticosteroids during hospitalization (day 1 to day 5)
    between treatment arms
    b. Mean total cumulative dose from recruitment to 3-month follow-up
    7) Hyperglycemia during admission
    8) One or more of the following adverse effects:
    - Changes in the rate of bone turnover (bone turnover markers): during hospitalization, 1 month and 3 month follow-up
    - Dyspepsia, change in dyspepsia medication or gastrointestinal bleeding: during hospitalization, 1 month and 3 month follow-up
    - New onset or worsening of diabetes mellitus : during hospitalization and 1 month follow-up
    - Increase in body mass index : during hospitalization, 1 month and 3 month follow-up
    - Change in vitamin D status or PTH function: during hospitalization, 1 month and 3 month follow-up
    9) The impact of COPD (cough, sputum, dysnea, chest tighteness) on health status (COPD Assessment Test): during hospitalization, 1 month and 3 month follow-up
    10) MRC score: during hospitalization, 1 month and 3 month follow
    11) Osteoporotic fractures from hospitalization and 360 days follow-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the time of hospitalization and 1 month- and 3 month follow-up
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned3
    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 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
    Last visit last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 290
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with lung disease, who often have other complex co-morbidities
    F.4 Planned number of subjects to be included
    F.4.1In the member state320
    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 Decision2016-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-06
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