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    Summary
    EudraCT Number:2018-002529-48
    Sponsor's Protocol Code Number:WADA2018vil
    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:2018-07-03
    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 number2018-002529-48
    A.3Full title of the trial
    Urine concentrations of vilanterol after inhaled administration of vilanterol/fluticasone furoate: Defining a urine threshold and decision limit for vilanterol in doping control analysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Urine concentrations of vilanterol after inhaled administration of vilanterol/fluticasone furoate: Defining a urine threshold and decision limit for vilanterol in doping control analysis
    A.4.1Sponsor's protocol code numberWADA2018vil
    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 SponsorCenter for Aktiv Sundhed, Rigshospitalet
    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 supportGlaxoSmithKline (GSK PHARMA)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Aktiv Sundhed, Rigshospitalet
    B.5.2Functional name of contact pointCFAS
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityKøbenhavn
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.6E-maileriksorenhalvardhansen@gmail.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 Relvar Ellipta 184/22
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline (GSK Pharma)
    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 nameRelvar Ellipta 22/184
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE FUROATE
    D.3.9.1CAS number 397864-44-7
    D.3.9.4EV Substance CodeSUB26593
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number736
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVilanterol (as trifenatate)
    D.3.9.1CAS number 503070-58-4
    D.3.9.3Other descriptive nameVILANTEROL TRIFENATATE
    D.3.9.4EV Substance CodeSUB36527
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number88
    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 Yes
    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
    Pharmacokinetics of vilanterol in relation to doping analysis
    Vilanterols farmakokinetik i relation til dopinganalyser.
    E.1.1.1Medical condition in easily understood language
    Pharmacokinetics of vilanterol in relation to doping analysis
    Vilanterols farmakokinetik i relation til dopinganalyser.
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10053349
    E.1.2Term Pharmacokinetic study
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine urine concenctrations of vilanterol and its metabolites after therapeutic and supratherapeutic use.
    At afgøre urinkoncentrationen af vilanterol og dens metabolitter efter terapeutisk hhv supraterapeutisk forbrug.
    E.2.2Secondary objectives of the trial
    To determine urine concentrations of vilanterol and its metabolites after 7 days of therapeutic and supratherapeutic use.
    At afgøre urinkoncentrationen af vilanterol og dens metabolitter efter 7 dages terapeutisk hhv supraterapeutisk forbrug.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Included subjects are:
    - Healthy
    - 18 - 39 years
    - Able to use an inhalation device
    - Active at least 5 hours a week
    - VO2-max classified as high or very high measured during incremental test to exhaustion during the screening visit
    - Male or non-pregnant female
    - Females of childbearing potential has to use one or more methods for contraception in order to be included: vasectomised partner, bilateral tubal occlusion, sexual abstinence, intrauterine device or hormonal contraception.
    - Females who are considered to have no childbearing potential are: bilateral tubal ligation, bilateral oophorectomy, complete hysterectomy, postmenopausal defined as 12 months with no menses without an alternative Medical cause.
    - Non-smokers
    - No daily use of prescribed medicine
    Inkluderede patienter er:
    - Raske
    - 18-39 år gamle
    - Kan bruge en inhalationsdevice
    - Aktive minimum 5 timer om ugen
    - VO2-max klassificered som høj eller meget høj målt ved screening.
    - Mand eller ikke-gravid kvinde
    - Kvinder i fertil alder skal have aktiv prævention for at deltage: vasektomeret partner, bilateral tubal okklusion, sexuel abstinens, spiral eller hormonel kontraception
    - Kvinder som ikke vurderes ikke at være fertile er: bilateral tubal ligation, bilateral oophorektomi, total hysterektomi eller postmenopausale vurderet som 12 måneder uden menstruation uden anden medicinsk årsag.
    E.4Principal exclusion criteria
    - Diagnosis of Heart, pulmonary (including asthma GINA 2-5), intestinal and renal diseases
    - Allergy towards active drug or any substances used in the drug
    - Non-compliance with the protocol
    - Diagnosticeret hjerte- eller lungesygdom (inklusive astma GINA 2-5)
    - Diagnosticeret tarm- eller nyresygdomme
    - Allergi overfor aktiv substans eller indholdet i substansen
    - Non-compliant overfor protokollen
    E.5 End points
    E.5.1Primary end point(s)
    Urineconcentration of vilanterol and its metabolites (GSK932009 and GW630200) after inhalation of Relvar.
    Urinkoncentration af vilanterol og dens metabolitter (GSK932009 og GW630200) efter inhalation af Relvar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated last part of 2018
    Endpoints bliver evalueret i slutningen af 2018
    E.5.2Secondary end point(s)
    Not applicable
    Intet at angive
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Intet at angive
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    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 fra sidste inkluderet individ
    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 months4
    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: 26
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state26
    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
    Intet
    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 Decision2018-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-14
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