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    The EU Clinical Trials Register currently displays   43883   clinical trials with a EudraCT protocol, of which   7296   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).

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    Summary
    EudraCT Number:2015-000053-21
    Sponsor's Protocol Code Number:FLUI-2014-134
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-000053-21
    A.3Full title of the trial
    Placebo controlled study to assess the effect of Roflumilast in hyperinflated COPD patients in addition to LABA/LAMA therapy using Functional Respiratory Imaging.
    Placebo-gecontroleerde studie om het effect van Roflumilast bij COPD-patiënten met hyperinflatie te beoordelen bovenop LABA / LAMA therapie met behulp van functionele respiratoire beeldvorming.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the effect of Roflumilast in hyperinflated COPD patients by using Functional Respiratory Imaging.
    Evaluatie van het effect van Roflumilast bij COPD-patiënten met hyperinflatie met behulp van functionele respiratoire beeldvorming.
    A.4.1Sponsor's protocol code numberFLUI-2014-134
    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 SponsorFLUIDDA nv
    B.1.3.4CountryBelgium
    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 supportFLUIDDA nv
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFLUIDDA nv
    B.5.2Functional name of contact pointJan De Backer
    B.5.3 Address:
    B.5.3.1Street AddressGroeningenlei 132
    B.5.3.2Town/ cityKontich
    B.5.3.3Post code2550
    B.5.3.4CountryBelgium
    B.5.4Telephone number3234508720
    B.5.5Fax number3234508729
    B.5.6E-mailjan.debacker@fluidda.com
    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 Daxas
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Film-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 INNROFLUMILAST
    D.3.9.1CAS number 162401-32-3
    D.3.9.4EV Substance CodeSUB10358MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboFilm-coated tablet
    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)
    chronisch obstructieve longziekte
    E.1.1.1Medical condition in easily understood language
    COPD includes chronic bronchitis and emphysema (= less elastic lungs, shortness of breath may occur) and is characterized by airway narrowing that is not fully reversible.
    COPD omvat chronische bronchitis en emfyseem (= longen zijn minder rekbaar waardoor kortademigheid kan voorkomen) en wordt gekenmerkt door luchtwegvernauwing die niet volledig omkeerbaar is.
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    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 assess the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy.
    E.2.2Secondary objectives of the trial
    The secondary study objective is to obtain data about the health related quality of life, lung function tests and exercise tolerance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patient ≥ 30 years old
    2. Written informed consent obtained
    3. Patient with Body mass index (BMI) ≥ 20
    4. Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
    5. COPD patient with GOLD stages C and D
    6. Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation
    7. Patient with smoking history of at least 10 pack-years
    8. Patient takes a combination therapy of LABA/ LAMA at least 6 weeks before visit 1
    9. Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions
    E.4Principal exclusion criteria
    1. Pregnant or lactating females
    2. Patient with severe immunological diseases and/ or severe acute infectious diseases
    3. Patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1
    4. Patient with diagnosis of cancer (except basal cell carcinoma)
    5. Patient with a history of depression associated with suicidal ideation or behaviour
    6. Patient with moderate or severe hepatic impairment.
    7. Patient with lactose intolerance
    8. Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
    9. Patient who received inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit
    10. Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer)
    E.5 End points
    E.5.1Primary end point(s)
    - Airway volume (iVaw)
    - Airway resistance (iRaw)
    - Lobe volumes (iVlobes)
    - Air trapping
    - Internal Lobar Airflow Distribution
    - Low Attenuation or Emphysema Score
    - Blood Vessel Density
    - Airway Wall Thickness
    - Aerosol deposition concentrations
    E.5.1.1Timepoint(s) of evaluation of this end point
    January 2017
    E.5.2Secondary end point(s)
    - Spirometry:
    • FEV1
    • Peak Expiratory Flow (PEF)
    • Forced Vital Capacity (FVC)
    • Maximum Expiratory Flow at 50% of FVC (MEF 50)
    • Maximum Expiratory Flow at 25% of FVC (MEF 25)
    - Body plethysmography:
    • Residual Volume (RV)
    • TLC
    • FRC
    • Airway resistance (Raw)
    - Diffusion capacity
    • carbon monoxide transfer factor (TCO)
    • Alveolar volume (VA)
    - 6MWT:
    • Exercise capacity: distance walked in 6 minutes (m), oxygen saturation measurement will be performed during the test
    - PRO:
    • Borg CR10 Scale: measure of the present dyspnea and leg fatigue before and after exercise
    • COPD assessment test (CAT): measure of the impact of COPD on your life
    • Saint George’s Respiratory Questionnaire (SGRQ): measure health related quality of life and comfort
    E.5.2.1Timepoint(s) of evaluation of this end point
    January 2017
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 No
    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 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
    LVLP
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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)
    Normal treatment of COPD patients
    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 Decision2015-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-15
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