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    Summary
    EudraCT Number:2018-002466-39
    Sponsor's Protocol Code Number:MVD-PROT-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-002466-39
    A.3Full title of the trial
    Morphine or Fentanyl for Refractory dyspnea in COPD
    Morfine of fentanyl voor refractaire dyspnoe bij COPD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Opioids for severe Shortness of Breath in Chronic Obstructive Pulmonary Disease
    Opiaten voor hardnekkige kortademigheid in chronische obstructieve longziekte (COPD)
    A.3.2Name or abbreviated title of the trial where available
    MoreFoRCOPD
    MoreFoRCOPD
    A.4.1Sponsor's protocol code numberMVD-PROT-001
    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 Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportInnovatiefonds Zorgverzekeraars
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportDepartment Pulmonary Diseases and Tuberculosis, University Medical Hospital Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointMarlies van Dijk
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00315012357
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameMorphine hydrochloride trihydrate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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 Fentanyl Sandoz Matrix
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameFentanyl
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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 placeboCutaneous patch
    D.8.4Route of administration of the placeboCutaneous use
    D.8 Placebo: 2
    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
    Chronic Obstructive Pulmonary Disease, COPD
    Chronische obstructieve longziekte, COPD
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD) is a term that is used to include chronic bronchitis, emphysema, or a combination of both conditions.
    Chronische obstructieve longziekte (COPD) is een verzamelnaam voor chronische bronchitis en emfyseem.
    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 PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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
    We will investigate the following hypothesis: Fentanyl patches provide reduction of dyspnea compared to placebo, comparable to morphine, and with less side effects than morphine.
    We zullen de volgende hypothese onderzoeken: fentanylpleisters geven een betere reductie van dyspnoe dan placebo, een even goede reductie van dyspnoe als morfine, en met minder bijwerkingen dan morfine.
    E.2.2Secondary objectives of the trial
    With this Dutch multi-center study we would like to enlarge the evidence base and contribute to the experience with opioids for refractory dyspnea in COPD thereby greatly facilitating its implementation in the Netherlands.
    And we will develop and evaluate educational material about opioid use for dyspnea in COPD to greatly enhance the implementation of opioids for this indication.
    We willen met deze studie in een groot aantal Nederlandse ziekenhuizen bijdragen aan de ervaring en evidence base over mogelijkheden en nadelen van opioiden bij refractaire dyspnoe bij COPD, om bij te dragen aan de implementatie van deze behandeling in Nederland.
    Ook zullen we voorlichtingsmateriaal over opioiden bij kortademigheid door COPD ontwikkelen en evalueren om bij te dragen aan de implementatie van deze behandeling in Nederland.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • COPD GOLD class III or IV, according to GOLD criteria.
    - Post-bronchodilatation FEV1/FVC < 70% and FEV1 < 50% pred.
    • Complaints of refractory dyspnea as established by patient and doctor.
    • mMRC score ≥ 3.
    • Life expectancy of ≥ 2 months.
    • Optimized standard therapy according to Dutch LAN guideline for diagnosis and treatment of COPD.
    • COPD GOLD klasse III en IV, volgens GOLD criteria (Post-bronchodilatatie FEV1/FVC < 70% en FEV1 < 50% van voorspeld)
    • Refractaire dyspnoe vastgesteld door patient en dokter
    • mMRC score ≥ 3.
    • Levensverwachting van ≥ 2 maanden.
    • Optimale standaardbehandeling volgende de zorgstandaard COPD van de Long Alliantie Nederland.
    E.4Principal exclusion criteria
    • Other severe disease with chronic pain or chronic dyspnea (a non-susbstantial component of left sided heart failure is acceptable).
    • Current use of opioids for whatever indication
    • Allergy / intolerance for opioids
    • Psychiatric disease, not related to severe COPD.
    • Exacerbation of COPD eight weeks prior to inclusion or between screening and randomization.
    • Problematic (leading to medical help or social problems) substance abuse during the last five years.
    • Active malignancy, with the exception of planocellular or basal cell carcinoma of the skin.
    • eGFR <15 ml/min
    • Andere ernstige comorbiditeit die chronische pijn of kortademigheid veroorzaakt, met uitzondering van niet substantieel linkszijdig
    chronisch hartfalen.
    • Huidig gebruik van opioiden, ongeacht de indicatie.
    • Aanwezigheid van een psychiatrische aandoening, niet gerelateerd aan ernstig COPD.
    • Een COPD-exacerbatie acht weken voor inclusie, of in de periode tussen screening en randomisatie.
    • Problematisch middelenmisbruik (leidend tot medische zorg of sociale problemen) in de afgelopen vijf jaar.
    • Actieve maligniteit, met uitzondering van een plaveiselcel- of basaalcelcarcinoom van de huid.
    • Nierklaring < 15 ml/min.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in dyspnea sensation
    Het primaire eindpunt is verandering in dyspnoesensatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint will be evaluated when the last participant has ended the treatment period.
    Dit eindpunt kan worden geëvalueerd op het moment dat de laatste deelnemer de behandelperiode heeft afgerond.
    E.5.2Secondary end point(s)
    Secondary endpoints are change in HR-QoL, anxiety, sleep quality, hypercapnia and the number and seriousness of side effect.
    Secundaire eindpunten zijn verandering in gezondheidsgerelateerde kwaliteit van leven, angst, slaapkwaliteit, hypercapnie en hoeveelheid en ernst van bijwerkingen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These secundary endpoints will be evaluated when the last participant has ended the treatment period.
    Deze secundaire eindpunten kunnen worden geëvalueerd op het moment dat de laatste deelnemer de behandelperiode heeft afgerond.
    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 No
    E.8.1.6Cross over Yes
    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 trial3
    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 concerned10
    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
    Laatste visite laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 30
    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 state60
    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)
    Participants may choose to continue morphine tablets or fentanyl patches when finishing the trial.
    Deelnemers kunnen ervoor kiezen om morfinetabletten of fentanylpleisters te continueren na afronden van de onderzoeksdeelname.
    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 Decision2018-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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