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    Summary
    EudraCT Number:2015-000982-30
    Sponsor's Protocol Code Number:4993/15
    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:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-000982-30
    A.3Full title of the trial
    Personalized pharmacological treatment of chronic obstructive pulmonary disease based on phenotyping: interventional study
    Terapia farmacologica personalizzata in pazienti con broncopneumopatia cronica ostruttiva basata su fenotipizzazione: studio interventistico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    na
    na
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code number4993/15
    A.5.4Other Identifiers
    Name:non disponibileNumber:na
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    B.1.3.4CountryItaly
    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 supportFONDAZIONE ROMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPOLICLINICO A. GEMELLI
    B.5.2Functional name of contact pointUNITA' OPERATIVA COMPLESSA DI FARMA
    B.5.3 Address:
    B.5.3.1Street AddressL.GO GEMELLI 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630156092
    B.5.5Fax number0630156292
    B.5.6E-mailpmontuschi@rm.unicatt.it
    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 SERETIDE - DISKUS 50/500 1 INALATORE 60 DOSI POLV PER INALAZ
    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 nameSeretide diskus 50/500
    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 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 SEREVENT - 50 MCG POLVERE PER INALAZIONE INALATORE DA 60 DOSI
    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 nameSerevent
    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 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: 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 SPIRIVA - 30 CAPSULE IN BLISTER AL/PVC/AL DA 18 MCG CON DISPOSITIVO HANDIHALER
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    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 nameSpiriva Handihaler
    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 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
    Chronic obstructive pulmonary disease (COPD)
    Broncopneumopatia cronica ostruttiva (BPCO)
    E.1.1.1Medical condition in easily understood language
    Pulmonary emphysema and chronic bronchitis
    enfisema polmonare e bronchite cronica
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10070975
    E.1.2Term Chronic obstructive bronchopneumopathy
    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
    1. Comparing the efficacy of ICS/LABA/LAMA vs LABA/LAMA in COPD patients with non-mixed phenotype (non-ACOS).
    1. Comparare l¿efficacia della terapia con ICS/LABA/LAMA vs LABA/LAMA in pazienti BPCO con fenotipo non misto (non-ACOS).
    E.2.2Secondary objectives of the trial
    1. Identifying molecular [gas chromatography/mass spectrometry (GC/MS), fraction of exhaled nitric oxide (FENO), electronic noses (e-noses), bacterial gene sequencing for airway microbiome identification], cellular (sputum analysis), imaging (chest multidetector row computed tomography, MDCT), biochemical [8-isoprostane and prostaglandin (PGE2) concentrations, both reported to be elevated in exhaled breath condensate (EBC) from COPD patients (17,18); PGE2 concentrations in sputum supernatants], and functional [including body plethysmography, forced oscillation technique (FOT), and single breath nitrogen washout] phenopypes, based on an innovative and validated platform, which is required for a better definition of non-mixed COPD phenotypes, for a more comprehensive consideration of the study covariates to be included in a pre-defined post-hoc analysis and, more importantly, for translating molecular phenotyping into a more personalized
    1. Identificazione molecolare [gas cromatografia/spettrometria di massa (GC/MS), monossido di azoto nell¿aria espirata (FENO), naso elettronico (e-noses), sequenziamento genico batterico per l¿identificazione del microbioma delle vie aeree], cellulare (analisi dell¿espettorato), d¿immagine (chest multidetector row computed tomography MDCT), biochimica [concentrazione di 8-isoprostano e prostaglandine (PGE2), entrambe elevate nel condensato del respiro esalato (EBC) di pazienti con BPCO (17,18); concentrazione di PGE2 nel sovranatante dell¿espettorato] e funzionale [pletismografia, tecnica di oscillazione forzata (FOT), lavaggio con azoto a singolo respiro] fenotipi, basati su una piattaforma innovativa e validata, che ¿ richiesta per una migliore definizione di fenotipi BPCO non-misti, per una pi¿ globale considerazione dello studio covariato che include un¿analisi predefinita per la traslazione dei fenotipi molecolari in una terapia farmacologica maggiormente personalizzata
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, >60 and <85 years of age.
    2. COPD (stage II-IV) based on GOLD guidelines with a FEV1/FVC < 70% and FEV1 <60% of the predicted value (6).
    3. Reversibility to 400 µg equivalent of salbutamol <200 ml and <12% predicted value FEV1(6).
    4. At least one COPD exacerbation in the previous year.
    5. No acute exacerbations or upper respiratory tract infection in the previous 4 weeks.
    6. No history of systemic disease or other pulmonary disease.
    7. No ICS or systemic glucocorticoids in the previous 4 weeks.
    8. No history of asthma or atopic disease.
    9. Allowed treatment for COPD at visit 1: short-acting beta2-agonists alone as needed and LAMA and/or LABA on regular basis. If on different LAMA and/or LABA, at visit 1, patients will be shifted to study bronchodilators as described above.
    10. Patients able to complete the study.
    11. Ability to perform reproducible spirometry.
    12. Patient is an ex smoker and has stopped smoking for at least 6 months.
    13. Ability of patient to provide informed consent
    1. Maschi o femmine, >60 e <85 anni di età.
    2. COPD (stadio II-IV) basata su linee guida GOLD con FEV1/FVC <70% e FEV1 <60% del valore predetto (6).
    3. Reversibilità a 400 µg di salbutamolo <200 ml e <12% del valore predetto di FEV1(6).
    4. Almeno una riacutizzazione nell’anno precedente.
    5. Nessuna riacutizzazione acuta o infezione delle vie aeree superiori nelle precedenti 4 settimane.
    6. Nessuna storia di malattie sistemiche o altre malattie polmonari.
    7. Nessuna terapia con ICS o glucocorticoidi sistemici nelle precedenti 4 settimane.
    8. Nessuna storia di asma o malattie atopiche.
    9. Terapia permessa ai pazienti in visita 1: SABA all’occorrenza e LAMA e/o LABA regolarmente. Se in terapia con differenti LAMA e/o LABA, alla visita 1 al paziente sarà cambiata la terapia come descritto sopra.
    10. Il paziente deve essere in grado di completare lo studio.
    11. Deve effettuare spirometrie riproducibili.
    12. Il paziente deve essere un ex-fumatore, non fumatore da almeno 6 mesi.
    13. Il paziente deve firmare il consenso informato prima di iniziare lo studio.
    E.4Principal exclusion criteria
    1. Inability to provide informed consent
    2. Patient is hospitalized
    3. Major surgical procedure in the previous four weeks
    4. Participation in a clinical trial in the previous four weeks
    5. Patient is current smoker
    6. No COPD exacerbation in the previous year.
    7. Patient has been hospitalized for COPD in the previous two months.
    8. Other respiratory diseases in addition to COPD
    9. Glaucoma
    10. Any illness that could be immediately life threatening.
    11. Upper respiratory infections or exacerbations in the previous 4 weeks.

    1. Il paziente non firma il consenso informato.
    2. Il Paziente é ricoverato in ospedale.
    3. Operazioni chirurgiche maggiori nei precedenti 4 mesi.
    4. Ha partecipato ad uno studio clinico nelle precedenti 4 settimane.
    5. Il paziente è attualmente fumatore.
    6. Nessuna riacutizzazione nell’ultimo anno.
    7. Paziente ricoverato per BPCO nei precedenti 2 mesi.
    8. Altre patologie respiratorie oltre a BPCO
    9. Glaucoma
    10. Altre malattie che potrebbero provocare rischio di morte per il paziente.
    11. Infezione delle vie aeree superiori o riacutizzazione nei precedenti 4 mesi.

    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of 1) one moderate or severe COPD exacerbation during the 52-week treatment phase (V3-V6), or 2) one episode of decrease in trough FEV1 = 15% on the volume scale or = 10% on the predicted scale or = 200 ml during the 52-week treatment phase (V3-V6) compared with pre-bronchodilator FEV1 at pre-treatment visit (V2) (8). The occurrence and severity of COPD exacerbations will be defined based on GOLD guidelines (6).
    1)Una moderata o severa riacutizzazione durante le 52 settimane di terapia (V3-V6), o 2) un episodio di diminuzione del FEV1 = 15% sulla scala del volume o = 10% sulla scala del predetto o = 200 ml durante le 52 settimane di terapia (V3-V6) comparata con pre-broncodilatatore FEV1 alla visita di pre-trattamento (V2) (8). La severità delle riacutizzazioni sarà definita sulla base delle linee guida GOLD (6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 settimane
    E.5.2Secondary end point(s)
    Molecular:
    1. E-Nose (Cyranose 320) sensor 1-32 resistance change
    2. E-nose (Libranose) sensor 1-8 frequency change
    3. Breath VOC concentrations identified and quantified by GC/MS
    4. FENO
    Functional:
    1. pre- and post-bronchodilator FEV1
    2. pre- and post-bronchodilator forced vital capacity (FVC)
    3. pre- and post-bronchodilator FEV1/FVC
    4. pre- and post-bronchodilator peak expiratory flow (PEF)
    5. pre- and post-bronchodilator forced expiratory flow at 25%-75% of the FVC (FEF25%-75%)
    6. pre- and post-bronchodilator total lung capacity (TLC)
    7. pre- and post-bronchodilator airway resistance (Raw)
    8. pre- and post-bronchodilator specific airway conductance (sGaw)
    9. nitrogen (N2) difference 0.75-1.25 (slope of phase III of single breath N2 washout)
    10. closing volume (CV) (phase IV of single breath N2 washout)
    11. pre- and post-bronchodilator FOT parameters
    Cellular
    1. Neutrophil cell counts in sputum
    2. Macrophage cell counts in sputum
    3. Eosinophil cell counts in sputum
    4. Lymphocyte cell counts in sputum
    5.Total cell counts in sputum
    Biochemical:
    1. 8-Isoprostane concentrations in EBC
    2. PGE2 concentrations in EBC
    3. PGE2 concentrations in sputum
    4. Urinary 8-isoprostane
    Imaging
    1. Airway lumen area (LA)
    2. Percentage of airway wall area (WA%)
    3. Airway wall thickness (WT)
    4. Percentage of wall thickness (WT%)
    5. Airway wall volume (WV)
    6.10 mm lumenal perimeter (pi10) WA
    7. percentage of volume index (VI%) < -950 HU for emphysema
    8. VI% < -850 HU for air trapping
    9. Mean lung density (MLD) expiration/inspiration (E/I)
    10. VI -850 E-I (%)
    11. Percentage of wall volume (WV%)
    Patient reported outcome:
    1. St. George Respiratory Questionnaire (SGRT)
    Molecolare:
    1. E-nose (Cyranose 320) sensori 1-32, cambio di resistenza.
    2. E-nose (Libranose) sensori 1-8, cambio di frequenza.
    3. Identificazione e quantificazione di composti volatili (VOCs) nel respiro dei pazienti mediante GC/MS.
    4. FENO
    Funzionale:
    1. FEV1 pre e post-broncodilatatore
    2. Capacit¿ vitale forzata (FVC) pre e post-broncodilatatore
    3. FEV1/FVC pre e post broncodilatatore
    4. Picco di flusso espiratorio (PEF) pre e post-broncodilatatore
    5. Flusso espiratorio forzato al 25%-75% del FVC pre e post- broncodilatatore (FEF25%-75%)
    6. Capacit¿ polmonare totale (TLC) pre e post-broncodilatatore
    7. Resistenza delle vie aeree pre e post-broncodilatatore (Raw)
    8. Conduttanza specifica delle vie aeree pre e post-broncodilatatore (sGaw)
    9. Differenza N2 0,75-1,25 (pendenza di fase III del lavaggio con azoto a singolo respiro)
    10. Volume di chiusura (CV) (fase IV del lavaggio con azoto a singolo respiro)
    11. Parametri FOT pre e post-broncodilatatore
    Cellulare:
    1. Conta cellulare dei neutrofili nell¿espettorato indotto
    2. Conta cellulare dei macrofagi nell¿espettorato indotto
    3. Conta cellulare degli eosinofili nell¿espettorato indotto
    4. Conta cellulare dei linfociti nell¿espettorato indotto
    5. Conta cellulare totale nell¿espettorato indotto.
    Biochimico:
    1. Concentrazione dell¿8-isoprostano nel EBC
    2. Concentrazione di PGE2 nel EBC
    3. Concentrazione di PGE2 nell¿espettorato
    4. 8-isoprostano urinario
    Immagine:
    1. Area del lume delle vie aeree (LA)
    2. Percentuale di superficie della parete delle vie aeree (WA%)
    3. Spessore della parete delle vie aeree (WT)
    4. Percentuale di parete delle vie aeree (WT%)
    5. Volume della parete delle vie aeree (WV)
    6. Perimetro lumenale di 10 mm (pi10) WA
    7. Percentuale di indice di volume (VI%) < -950 HU per enfisema
    8. VI% < -850 HU per intrappolamento dell¿aria
    9. Densit¿ media del polmone (MLD) espirazione/inspirazione (E/I)
    10. VI -850 E-I (%)
    11. Percentuale del volume di parete (WV%)
    Outcome riportato dal paziente:
    1. Questionario respiratorio St. George (SGRT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 settimane
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 118
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state168
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 168
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    normal clinical practice
    normale 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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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