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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2021-001449-11
    Sponsor's Protocol Code Number:CLI-01535AA0-02
    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:2021-10-12
    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 number2021-001449-11
    A.3Full title of the trial
    An exploratory, double-blind, randomised, multicenter, psychopharmacological study in adult patients with moderate to severe asthma to compare two pressurised Metered-Dose Inhalers (pMDIs) on patients’ perception of asthma symptoms.
    Studio psicofarmacologico esplorativo, randomizzato, multicentrico in doppio cieco in pazienti adulti affetti da asma da moderata a grave per il confronto di due inalatori pressurizzati predosati (pMDI) sulla percezione dei sintomi dell'asma da parte dei pazienti.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with adult asthmatic patients to understand how asthma symptoms are perceived by comparing two inhalers.
    Studio con pazienti adulti asmatici per capire come vengono percepiti i sintomi dell'asma confrontando due inalatori.
    A.3.2Name or abbreviated title of the trial where available
    FEEL
    FEEL
    A.4.1Sponsor's protocol code numberCLI-01535AA0-02
    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 SponsorCHIESI FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    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 supportChiesi Farmaceutici S.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi Farmaceutici S.p.a.
    B.5.2Functional name of contact pointGlobal Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressVia Palermo 26/A
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43122
    B.5.3.4CountryItaly
    B.5.4Telephone number003905212791
    B.5.6E-mailclinicaltrials_info@chiesi.com
    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 FOSTER - 100/6 MICROGRAMMI PER EROGAZIONE SOLUZIONE PRESSURIZZATA PER INALAZIONE
    D.2.1.1.2Name of the Marketing Authorisation holderCHIESI FARMACEUTICI 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 nameBeclometasone dipropionato e formoterolo fumarato
    D.3.2Product code [CHF1535]
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    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 DIPROPIONATO
    D.3.9.1CAS number 5534-09-8
    D.3.9.2Current sponsor codeCHF718
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROLO FUMARATO DIIDRATO
    D.3.9.1CAS number 43229-80-7
    D.3.9.2Current sponsor codeCHF1531.02
    D.3.9.4EV Substance CodeSUB25660
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 FOSTER - 100/6 MICROGRAMMI PER EROGAZIONE SOLUZIONE PRESSURIZZATA PER INALAZIONE
    D.2.1.1.2Name of the Marketing Authorisation holderCHIESI FARMACEUTICI 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 nameBeclometasone dipropionato e formoterolo fumarato diidrato
    D.3.2Product code [CHF1535]
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    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 Dipropionato
    D.3.9.1CAS number 5534-09-8
    D.3.9.2Current sponsor codeCHF718
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROLO FUMARATO DIIDRATO
    D.3.9.1CAS number 43229-80-7
    D.3.9.2Current sponsor codeCHF1531.02
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Moderate to severe asthma
    Asma da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Moderate to severe asthma
    Asma da moderata a grave
    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 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
    To assess the perception of symptoms and the psychopharmacological aspects in moderate to severe asthma subjects comparing two inhalers of CHF1535 100/6 µg pMDI.
    Valutare la percezione dei sintomi e gli aspetti psicofarmacologici in soggetti affetti da asma da moderata a grave confrontando due inalatori di CHF1535 100/6 µg pMDI.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject’s and/or subject legal representative’s written informed consent obtained prior to any study related procedure.
    2. Age: >=18 and <=75 years of age.
    3. Diagnosis of asthma: Established diagnosis of permanent asthma for at least 6 months prior to screening/randomisation visit, with documented history of variable respiratory symptoms and confirmed variable expiratory airflow limitation according to the description in the Box 1-2 of the 2020 GINA Report.
    4. Current asthma therapy: Subject on maintenance therapy treated by Foster® (CHF1535 100/6 µg pMDI) for at least 6 months prior to screening/randomisation visit (A subject under Foster® MART indication is eligible).
    5. Asthma control: Asthma Control Test (ACT) >= 20 at screening/randomisation visit.
    6. Ability to comply with the protocol: Subject must have a cooperative attitude and the ability to be trained to use correctly the diary and answer the Visual Analogue Scale (VAS), to be able to perform the required outcomes measurements and the ability to understand the risks involved.
    7. Subject willing and able to use their electronic device to download the application to fill in the study e-diary and to enable video communication.
    8. Female subjects:
    a. WOCBP fulfilling one of the following criteria:
    i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until Visit 4 or
    ii. WOCBP with non-fertile male partners (contraception is not required in this case).
    For the definition of WOCBP and of fertile men and the list of highly effective birth control methods, refer to Appendix 4.
    or
    b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile, as per definitions given in Appendix 4). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator’s request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).
    1. rilascio del consenso informato scritto del soggetto e/o del suo rappresentante legale prima di qualsiasi procedura correlata allo studio;
    2. età: >=18 e <=75 anni;
    3. diagnosi di asma: diagnosi di asma permanente pronunciata almeno 6 mesi prima della visita di screening/randomizzazione, con anamnesi documentata dei sintomi respiratori variabili e limitazione variabile del flusso espiratorio confermata secondo la descrizione riportata nel riquadro 1-2 del Rapporto GINA 2020;
    4. terapia per l'asma in corso: soggetto sotto terapia di mantenimento con Foster® (CHF1535 100/6 µg pMDI) da almeno 6 mesi prima della visita di screening/randomizzazione (sono ammessi i soggetti con indicazione di terapia di mantenimento e sollievo [Maintenance and Relieve Therapy, MART] con Foster®);
    5. controllo dell'asma: test di controllo dell'asma (Asthma Control Test, ACT) >= 20 alla visita di screening/randomizzazione;
    6. capacità di rispettare il protocollo: il soggetto deve avere un atteggiamento collaborativo e la capacità di essere istruito a utilizzare correttamente il diario e di rispondere alla scala visuo-analogica (Visual Analogue Scale, VAS), di eseguire le misurazioni dei risultati previste e di comprendere i rischi coinvolti;
    7. il soggetto deve essere disposto e in grado di utilizzare il proprio dispositivo elettronico per scaricare l'applicazione al fine di compilare il diario elettronico dello studio e consentire la comunicazione video.
    8. Soggetti di sesso femminile:
    a. donne fertili che soddisfano uno dei seguenti criteri:
    i. donne fertili con partner di sesso maschile fertile: la partecipante e/o il partner devono essere disposti a utilizzare un metodo anticoncezionale altamente efficace a partire dalla firma del consenso informato fino alla Visita 4 oppure
    ii. donne fertili con partner di sesso maschile non fertile (la contraccezione in questo caso non è richiesta).
    Per la definizione di donna fertile e di uomo fertile e per l'elenco dei metodi anticoncezionali altamente efficaci, consultare l'Appendice 4
    oppure
    b. soggetti di sesso femminile non fertili, definiti come fisiologicamente non in grado di avere una gravidanza (ossia in post-menopausa o permanentemente sterili secondo la definizione data nell'Appendice 4). Legatura delle tube o interventi chirurgici parziali non sono accettabili. Se indicato, in base alla richiesta dello sperimentatore, lo stato post-menopausale può essere confermato rilevando i valori dell'ormone follicolo-stimolante (secondo i range valoriali dei laboratori locali).
    E.4Principal exclusion criteria
    1. Pregnant or lactacting woman
    2. History of 'at risk' asthma: history of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the investigator may place the subject at undue risk
    3. Recent exacerbation: asthma exacerbation requiring systemic corticosteroids or emergency room admission or hospitalization within 4 weeks prior to screening/randomization visit
    4. Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine.
    5. Asthma requiring more than 1 inhaler for manteinance treatment and than more 1 inhaler for reliever treatment
    6. Asthma requiring use of biologics: asthma subject treated with chronic systemic corticosteroids or anti-IgE or other monoclonal or polyclonal antibodies.
    7. Respiratory disorders rather than asthma
    8. Subject with lower respiratory tract infection that required use of antibiotics within 4-6 weeks prior to screening/randomization
    9. Current smoker or ex-smoker with a smoking current use/history of >= 10 pack-years
    10. Cardiovascular disease
    11. Other concurrent disease
    12. Subject with a known or suspected history of alcohol and/or substance drug abuse within 12 months prior to screening/randomisation visit
    13. Subject who has received any investigational drug within the last 30 days (60 days for biologics) or a more appropriate time as determinated by the investigator
    14. Contra-indications to Foster®
    15. History of hypersensitivity to Foster® or any of its components or a history of other allergy that in the opinion of the investigator controindicates the subject's participation
    16. Subject mentally or legally incapacitated
    17. Blind, colour blind subject or any other dyschromatopsia
    18. Known psychiatric disorders that may interfere with successful completion of this protocol
    1. donne in gravidanza o allattamento
    2. anamnesi di asma a rischio: asma quasi fatale, ricovero ospedaliero per asma in unità di terapia intensiva che, secondo il parere dello sperimentatore, possono esporre il soggetto a rischio indebito
    3. aggravamento recente: aggravamento dell'asma con necessità di corticosteroidi sistemici o ricovero ospedaliero di emergenza o ricovero ospedaliero nelle 4 settimane precedenti la visita di screening/randomizzazione
    4. Asma non permanente: asma stagionale, asma indotta dall'esercizio fisico (come unica diagnosi correlata all'asma) senza necessità di farmaci per il controllo quotidiano della malattia
    5. asma con necessità di più di 1 inalatore per la terapia di mantenimento e più di 1 inalatore per la terapia di sollievo
    6. Asma richiedente l'uso di prodotti biologici: soggetto asmatico trattato con corticosteroidi sistemici cronici, anti-IgE o altri anticorpi monoclonali o policlonali
    7. malattie respiratorie diverse dall'asma
    8. soggetto con infezione delle vie respiratorie inferiori con necessità di ricorso agli antibiotici nelle 4-6 settimane precedenti lo screening/randomizzazione
    9. fumatore o ex-fumatore con consumo attuale/storico di = 10 pacchetti-anno
    10. patologie cardiovascolari
    11. altre malattie concomitanti
    12. soggetto con anamnesi nota o sospetta di abuso di alcol e/o sostanze stupefacenti/farmaci nei 12 mesi precedenti la visita di screening/randomizzazione
    13. soggetto che ha assunto un farmaco sperimentale negli ultimi 30 giorni (60 giorni per i farmaci biologici) o nel periodo più appropriato a parere dello sperimentatore
    14. controindicazioni all'uso di Foster®
    15. anamnesi di ipersensibilità a Foster® o a uno qualsiasi dei suoi componenti o anamnesi di altre allergie che, secondo il parere dello sperimentatore, costituiscono una controindicazione alla partecipazione del soggetto
    16. soggetto mentalmente o legalmente incapace
    17. cecità, daltonismo o qualsiasi altra discromatopsia
    18. disturbi psichiatrici noti che potrebbero interferire con il corretto svolgimento del presente protocollo
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentages of subjects (for questions with categorical outcome) or summary measures (for questions with continuous outcome) to questions covering subjects’ preference of device and outcome assessments;
    1. Percentuali di soggetti (per le domande con esito categoriale) o misure riepilogative (per le domande con esito continuo) relative alle domande circa la preferenza del dispositivo e le valutazioni dei risultati da parte dei soggetti;
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 43 (Visit 4)
    Giorno 43 (Visita 4)
    E.5.2Secondary end point(s)
    Change from baseline in reliever medication use after 14 days of treatment; Change from baseline in AQLQ score after 14 days of treatment; Adverse Events and Serious Adverse Events; Change from baseline in average VAS score evaluating subject perceptions of asthma symptoms after 7 days and 14 days of treatment;
    Variazione rispetto al basale dell'uso del farmaco di sollievo dopo 14 giorni di trattamento; Variazioni rispetto al basale del punteggio al questionario sulla qualità della vita delle persone asmatihe (Asthma Questionnaire Life Quality AQLQ) dopo 14 giorni di trattamento; Eventi avversi ed eventi avversi gravi; Variazione rispetto al basale del punteggio VAS medio relativo alla valutazione della percezione dei sintomi dell'asma da parte dei soggetti dopo 7 giorni e 14 giorni di trattamento;
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 14 days of treatment; After 14 days of treatment; Study duration; After 7 days and 14 days of treatment
    Dopo 14 giorni di trattamento; Dopo 14 giorni di trattamento; Durata dello studio; Dopo 7 giorni e 14 giorni di trattamento
    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) 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Esploratorio
    Exploratory
    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
    CHF1535 100/6 µg pMDI
    CHF1535 100/6 µg pMDI
    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 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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days14
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 75
    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)
    Patients will continue to follow the treatment according to standard routine care.
    I pazienti proseguiranno il loro piano di trattamento da pratica clinica.
    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 Decision2021-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 08 00:41:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA