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    Summary
    EudraCT Number:2017-002244-33
    Sponsor's Protocol Code Number:Astmaperiostin
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-22
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-002244-33
    A.3Full title of the trial
    Periostin-guided withdrawal of inhaled corticosteroids in patients with
    non-eosinophilic asthma
    Periostin-guidet udtrapning af inhalationssteroidbehandling hos patienter med non-eosinofil astma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Periostin-guided withdrawal of inhaled corticosteroids in patients with
    non-eosinophilic asthma
    Periostin-guidet udtrapning af inhalationssteroidbehandling hos patienter med non-eosinofil astma
    A.4.1Sponsor's protocol code numberAstmaperiostin
    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 SponsorRespiratory Research Unit Hvidovre, Department of Respiratory Medicine, Copenhagen University Hospital Hvidovre
    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 supportHvidovre Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRespiratory Research Unit Hvidovre, Department of Respiratory Medicine, Copenhagen University Hospital Hvidovre
    B.5.2Functional name of contact pointRespiratory Research Unit Hvidovre
    B.5.3 Address:
    B.5.3.1Street AddressKettegard Alle 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.4CountryDenmark
    B.5.4Telephone number4538621020
    B.5.6E-mailchristiane.mosbech@regionh.dk
    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.2.1.1.1Trade name Budesonid
    D.2.1.1.2Name of the Marketing Authorisation holderseveral companies
    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 namebudesonid
    D.3.2Product code budesonid
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.2Current sponsor codebudesonid
    D.3.9.4EV Substance CodeSUB05955MIG
    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 fluticasonpropionat
    D.2.1.1.2Name of the Marketing Authorisation holderfluticasonpropionat
    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 namefluticasonpropionat
    D.3.2Product code R03BA05
    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 INNfluticasonpropionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.2Current sponsor codefluticasonpropionat
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    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: 3
    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 mometasonfuroat
    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 namemometasonfuroat
    D.3.2Product code R03BA07
    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 INNmometasonfuroate
    D.3.9.2Current sponsor codemometasonfuroat
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.9.4EV Substance CodeSUB03318MIG
    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: 4
    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 fluticasonfuroat
    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 namefluticasonfuroat
    D.3.2Product code R03AK10
    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.3.9.2Current sponsor codefluticasonfuroat
    D.3.9.4EV Substance CodeSUB26593
    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: 5
    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 beclometasondipropionat
    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.3.4Pharmaceutical 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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.2Current sponsor codebeclometasondipropionat
    D.3.9.4EV Substance CodeSUB00681MIG
    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: 6
    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 ciclesonid
    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 nameciclesonid
    D.3.2Product code R03BA08
    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 INNCICLESONIDE
    D.3.9.1CAS number 141845-82-1
    D.3.9.2Current sponsor codeciclesonid
    D.3.9.4EV Substance CodeSUB06236MIG
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    Astma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Astma
    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 22.1
    E.1.2Level LLT
    E.1.2Classification code 10003555
    E.1.2Term Asthma bronchial
    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 aim is to investigate whether asthma patients expressing low T2-activity, assessed by Serum-Periostin, blood-eosinophils, and FeNO can sustain their level of disease control during tapering of ICS. The overall aim of the study is to reduce the burden of corticosteroids in these patients.
    At undersøge om patienter med non-eosinofil, non-allergisk astma, dvs. med lav T2-aktivitet bedømt ud fra S-periostin, kan opretholde samme niveau af sygdomskontrol uden behandling med ICS. Det overordnede sigte med studiet er at reducere steroidbyrden hos denne gruppe af patienter med astma.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Asthma patients followed in the Respiratory Outpatient Ward, Amager Hvidovre
    Hospital, Glostrup Hospital, Herlev-Gentofte Hospital, Bispebjerg Hospital.
    - At least one of the following test suggestive for asthma, performed at
    any time during the outpatient course:
    o 1) FEV1-reversibility of at least 12% and 200 ml after administration
    of bronkodilator or Prednisolon course.
    o 2) positiv bronkialprovokation test, such as mannitol, or
    o 3) peakflow (PF)- variation of at least 20% assessed during a 14-day period, measured twice daily and at asthmatic symptoms.
    o 4) Variability in FEV1 over time on at least 12% and 200 ml
    - Age 18-65 years
    - Treated with ICS daily in doses equivalent to Budesonid 800 microgram daily or more
    - ICS adherence of at least 80% during the last year, assessed from used prescriptions
    - FeNO < 25 ppb at all prior visits
    - Blood-eosinofils <0,15 at screening
    - Signed informed consent
    - Fertile women: negative U-HCG
    - Astmapatienter som følges i Lungemedicinsk ambulatorium, Amager Hvidovre Hospital, Glostrup Hospital, Herlev-Gentofte Hospital og Bispebjerg Hospital.
    - Astma diagnosen verificeret ved, på et hvilket som helst tidspunkt i ambulatorieforløbet, mindst en positiv af følgende astmatests:
    o 1) FEV1-reversibilitet mindst 12 % og 200 ml efter administration af bronkodilatator eller kortiko-steroidkur.
    o 2) Positiv bronkialprovokationstest, f.eks. mannitol, eller
    o 3) Peak-flow-variation på mindst 20 % (14-dages periode, målt 2x dgl. samt ved astmasymptomer).
    o 4) Variabilitet i FEV1 over tid på mindst 12 % og 200 ml.
    - Alder 18-65 år
    - I fast behandling med middel-dosis ICS eller højere (sv.t. budesonid 400 microgram x 2 dgl.)
    - ICS adherence mindst 80 % seneste år (bedømt ud fra indløste recepter)
    - FeNO < 25 ppb ved ambulante besøg inkl. screening
    - Blod-eosinofile <0,15 mia/L ved screeningsbesøget
    - For kvinder i fertil alder: negativ U-HCG samt tilkendegivelse om sikker antikonception i hele forsøgsperioden.
    - Underskrevet informeret samtykke
    E.4Principal exclusion criteria
    - History of allergic asthma
    - Doctor-diagnosed pneumonia within 6 weeks prior to screening
    - Daily smoking or former daily smoking within the last 6 months
    - Known other respiratory condition such as COPD or pulmonary
    sarcoidosis
    - Known other chronic conditions that could impact or prevent study participation, including severe heart conditions and conditions requiring treatment with immunosuppressive drugs such as Prednisolon, Methotrexate or biological treatments, assessed by study doctor
    - Pregnancy or planned pregnancy
    - Abuse of alcohol or other recreational drugs
    - Anamnese med allergisk astma
    - Lægediagnosticeret pneumoni seneste 6 uger inden screening
    - Aktuel daglig ryger eller tidligere daglig ryger indenfor de eneste 6 måneder
    - Anden kendt lungesygdom, inkl. KOL og sarcoidose
    - Anden kronisk sygdom som efter lægeligt skøn vurderes at have betydning for deltagelse i forsøget, f.eks. svær hjertesygdom og sygdom som behandles med fast (eller jævnligt behov for) prednisolon eller anden immuno-suppressiv medicin, f.eks. methotrexat eller behandling med biologiske lægemidler.
    - Aktuel eller planlagt graviditet
    - Misbrug af alkohol eller andre rusmidler
    E.5 End points
    E.5.1Primary end point(s)
    Change in Control Questionnaire (ACQ) from baseline to post-tapered
    ICS and/or time from baseline to drop-out because of worsening of asthma symptoms. Clinically significant change will be 0.5 points.
    Ændring i Asthma Control Questionnaire (ACQ) fra baseline til efter udtrappet ICS-behandling. Signifikant ændring defineres som min. 0.5 point og/eller tid til drop-out fra baseline pga. øgning i astmaaktivitet. (dvs. i alt 3.5 point).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 0, 4, 8, 12, 16, 26, 52.
    2. Single measurement at drop-out
    1. Uge 0, 4, 8, 12, 16, 26, 52
    2. Enkeltstående måling ved drop-out
    E.5.2Secondary end point(s)
    1. Change in FeNO
    2. Change in Serum-Periostin.
    3. Change in FEV1.
    4. Change in Blood-eosinophils
    5. Change in Sputum-eosinophils
    1. Ændring i FeNO
    2. Ændring i serum-periostin
    3. Ændring i FEV1
    4. Ændring i blod-eosinofile
    5. Ændring i sputum-eosinofile
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 0, 4, 8, 12, 16, 26, 52.
    2. Week 0, 8, 16, 52.
    3. Week 0, 4, 8, 12, 16, 26, 52.
    4. Week 0, 4, 8, 12, 16, 26, 52.
    5. Week 0, 52.
    1. Uge 0, 4, 8, 12, 16, 26, 52.
    2. Uge 0, 8, 16, 52
    3. Uge 0, 4, 8, 12, 16, 26, 52.
    4. Uge 0, 4, 8, 12, 16, 26, 52.
    5. Uge 0, 52
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comperator arm: usual asthma care. Active arm: tapering of inhaled corticosteroids
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 110
    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 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 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 state110
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 110
    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)
    When the subject has ended participation in the trial, he/she will continue treatment in the outpatient ward in the Respiratory Department of Hvidovre Univesityy Hospital
    Når forsøgsperioden er slut overgår patienterne til vanlig opfølgning og behandling i ambulatorieregi.
    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 Decision2017-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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