Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38963   clinical trials with a EudraCT protocol, of which   6398   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-000472-22
    Sponsor's Protocol Code Number:CQVM149B2303
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-000472-22
    A.3Full title of the trial
    A multi-center, randomized, 12-week treatment, double blind study to assess the efficacy and safety of QMF149 (150/80 microgram) compared with MF Twisthaler® (200 microgram) in adult and adolescent patients with asthma
    Studio multicentrico, randomizzato, in doppio cieco, della
    durata di 12 settimane per valutare l’efficacia e la sicurezza
    di QMF149 (150/80 microgrammi) verso MF Twisthaler®
    (200 microgrammi) in pazienti adulti e adolescenti con
    asma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of low dose QMF149 (150/80 microgram)
    compared with MF Twisthaler® in patients with asthma
    Efficacia e sicurezza di QMF149 (150/80 microgrammi) verso MF Twisthaler®in pazienti con asma
    A.3.2Name or abbreviated title of the trial where available
    n/a
    n/a
    A.4.1Sponsor's protocol code numberCQVM149B2303
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/104/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni 1
    B.5.3.2Town/ cityOriggio VA
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number00390296542287
    B.5.5Fax number0039029659066
    B.5.6E-mailinfo.studiclinici@novartis.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 No
    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 nameIndacaterol acetate / mometasone furoate
    D.3.2Product code QMF149
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNINDACATEROL ACETATE
    D.3.9.3Other descriptive nameINDACATEROL ACETATE
    D.3.9.4EV Substance CodeSUB32071
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOMETASONE FUROATE
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.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 Asmanex Twisthaler
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Inhalation powder
    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 INNMOMETASONE FUROATE
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    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 FLUSPIRAL 100 mcg Polvere per inalazione
    D.2.1.1.2Name of the Marketing Authorisation holderA. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi, 1 – Firenze Su licenza GlaxoSm
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameFLUSPIRAL
    D.3.2Product code NA
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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: 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 VENTOLIN
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameVentolin
    D.3.2Product code NA
    D.3.4Pharmaceutical form Suspension and solution for spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, hard capsule
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    poorly (ie inadequately)controlled asthma patients.
    pazienti adulti e adolescenti con asma
    E.1.1.1Medical condition in easily understood language
    Adult and Adolescent Patients With Asthma
    pazienti adulti e adolescenti con asma
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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
    The primary objective of this study is to demonstrate the superiority of QMF149
    150/80 microgram o.d. (in the evening) delivered via Concept1 compared with
    MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of
    trough FEV1 after 12 weeks of treatment in adults and adolescents.
    L’obiettivo primario di questo studio è di dimostrare la superiorità di QMF149 150/80 microgrammi o.d. (alla sera) somministrato con Concept1 rispetto a MF 200 microgrammi o.d. (alla sera) somministrato con Twisthaler®, in termini di FEV1 pre-dose dopo 12 settimane di trattamento, in pazienti adulti e adolescenti con asma
    E.2.2Secondary objectives of the trial
    The key secondary objective of this study is to demonstrate the superiority of QMF149
    150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks
    of treatment.
    L’obiettivo secondario principale è di dimostrare la superiorità di QMF149 150/80 microgrammi rispetto a MF 200 microgrammi o.d. in termini di ACQ-7 dopo 12 settimane di trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit
    - Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit
    -Adult patients who are symptomatic at screening despite treatment with existing therapy.
    Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (inadequately
    controlled).
    - Adolescent patients :
    If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score ≥ 1.5 at Visit 101
    and at Visit 102 .
    If taking ICS (low dose)/ LABA, and have ACQ-7 score ≥1 and <1.5 at Visit 101: they must have ACQ-7 score≥1.5 at Visit 102 ( prior to randomization).
    -Pre-bronchodilator FEV1≥ 60 % and < 90 % of the predicted normal value for the patient
    after withholding bronchodilators at both Visits 101 and 102
    -Patients who demonstrate an increase in FEV1 of 12% and ≥ 200 mL within 30 minutes after
    administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.
    Pazienti adulti con asma che sono sintomatici allo screening nonostante il trattamento con la terapia esistente. I pazienti devono avere un punteggio ACQ-7 ≥1.5 alla Visita 101 e alla Visita 102 (cioè inadeguatamente controllato).
    Pazienti adolescenti con asma:
    • pazienti che stanno assumendo basse dosi di ICS (senza LABA), che sono sintomatici allo screening nonostante il trattamento con ICS. Questi pazienti devono avere un punteggio ACQ-7 ≥1.5 alla Visita 101 e alla Visita 102 (cioè inadeguatamente controllato).
    • Pazienti che stanno assumendo una dose bassa di ICS/LABA, possono essere inclusi solo se il punteggio ACQ-7 ≥1 e < 1.5 alla Visita 101 (cioè adeguatamente controllato). Comunque il punteggio ACQ-7 deve essere ≥1.5 alla visita 102.
    FEV1 pre-dose ≥ 60% e < 90% del valore predetto normale
    Reversibilità di FEV1 ≥ 12% e ≥ 200 mL


    E.4Principal exclusion criteria
    • Patients who have smoked or inhaled tobacco products (including electronic
    cigarettes) within the 6 month period prior to Visit 1, or who have a smoking
    history of greater than or equal to 10 pack year.
    • Patients who have had an asthma attack/exacerbation requiring systemic
    steroids or hospitalization (> 24 hours) or emergency room visit (≤ 24 hours) as
    follows:
    • For adults: within 6 weeks of Screening Visit. If patients experience an asthma
    attack/exacerbation requiring systemic steroids or emergency room visit
    between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery
    from the exacerbation
    • For adolescents: Exacerbation requiring systemic steroids, hospitalization (> 24
    hours) or emergency room visit (≤24 hours) within 6 months, prior to visit 1.
    • Patients who ever required intubation for a severe asthma attack/exacerbation
    • Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures)
    which may be worsened by ICS administration (according to investigator's
    medical judgment )
    • Patients who have had a respiratory tract infection or asthma worsening within
    4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may
    be re-screened 4 weeks after recovery from their respiratory tract infection or
    asthma worsening.
    • Patients with any chronic conditions affecting the upper respiratory tract (eg.
    chronic sinusitis) which in the opinion of the investigator may interfere with the
    study.
    Patients with a history of chronic lung diseases other than asthma, including
    (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis,
    clinically significant bronchiectasis and active tuberculosis.
    • Patients with Type I diabetes or uncontrolled Type II diabetes.
    • Patients with narcolepsy and/or insomnia.
    • Patients on Maintenance Immunotherapy (desensitization) for allergies or less
    than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for
    more than 3 months prior to Visit 101 but expected to change throughout the
    course of the study.
    • Patients with diagnosed rare hereditary problems of galactose intolerance, the
    Lapp lactase deficiency or glucose-galactose malabsorption or with known
    intolerance to lactose or milk products.
    Donne in gravidanza/madri in allattamento
    Donne in età fertile (a meno che non usino un’adeguata contraccezione)
    Pazienti con anamnesi di patologia polmonare cronica diversa dall’asma comprese, ma non limitate a, BPCO, sarcoidosi, patologia polmonare interstiziale, fibrosi cistica, bronchiectasia clinicamente significativa, o tubercolosi attiva.
    Pazienti che siano attualmente fumatori o che inalino prodotti derivati dal tabacco (incluso le sigarette elettroniche) nei 6 mesi precedenti la visita 1 o ex-fumatori con una storia di fumo di ≥ 10 pacchetti per anno.
    Pazienti che hanno avuto un attacco/esacerbazione di asma che ha richiesto steroidi sistemici o ricovero ospedaliero (>24 ore) o visita in pronto soccorso (≤ 24 ore) come segue:
    • Per adulti: nelle 6 settimane precedenti la visita 1 (screening). Se i pazienti che hanno avuto un attacco/esacerbazione di asma che ha richiesto steroidi sistemici o ricovero ospedaliero o visita in pronto soccorso tra la visita 1 e la visita 102, possono essere ri-selezionati 6 settimane dopo il ricovero dall’esacerbazione.
    • Per gli adolescenti: esacerbazione di asma che ha richiesto steroidi sistemici o ricovero ospedaliero (>24 ore) o visita in pronto soccorso (≤ 24 ore) nei 6 mesi precedenti la visita 1.
    Pazienti con problemi ereditari di intolleranza al lattosio, carenza di Lapp lattasi o malassorbimento di glucosio-galattosio o una nota intollerenza al lattosio o derivati del latte
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measure:
    • trough FEV1 [Time Frame: week 12] [Designated as safety issue: No]
    demonstrate the superiority of QMF149 150/80 microgram o.d. (in the
    evening) delivered via Concept1 compared with MF 200 microgram
    o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1
    after 12 weeks of treatment in adults and adolescents.
    Forced Expiratory Volume in 1 second (FEV1) is the amount of air
    which can be forcibly exhaled from the lungs in the first second of a
    forced exhalation, measured by spirometry.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    to demonstrate the superiority of QMF149
    150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks
    of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    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 Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    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 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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Bulgaria
    Chile
    Colombia
    Estonia
    Germany
    Hungary
    India
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Sweden
    Thailand
    Vietnam
    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
    LVLS
    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 months16
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 850
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The younger children recruited in this trial may lack understandment of what a clinical trial is and its purpose, so their parents/guardians will give consent on their behalf
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 1000
    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
    Nessuno
    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 Decision2017-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-02
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA