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    Summary
    EudraCT Number:2016-004558-13
    Sponsor's Protocol Code Number:Z7224L02
    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:2020-10-21
    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 number2016-004558-13
    A.3Full title of the trial
    A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis
    chronically infected with Pseudomonas aeruginosa (P. aeruginosa)
    Studio clinico multicentrico, controllato con placebo, in doppio cieco, per valutare l’efficacia e la sicurezza di 12 mesi di terapia con colistimetato di sodio per via inalatoria nel trattamento di soggetti con bronchiectasie non
    da fibrosi cistica con infezione cronica da Pseudomonas aeruginosa (P. aeruginosa)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis
    chronically infected with Pseudomonas aeruginosa (P. aeruginosa)
    Studio clinico multicentrico, controllato con placebo, in doppio cieco, per valutare l’efficacia e la sicurezza di 12 mesi di terapia con colistimetato di sodio per via inalatoria nel trattamento di soggetti con bronchiectasie non
    da fibrosi cistica con infezione cronica da Pseudomonas aeruginosa (P. aeruginosa)
    A.3.2Name or abbreviated title of the trial where available
    Promis II
    Promis II
    A.4.1Sponsor's protocol code numberZ7224L02
    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 SponsorZAMBON SPA
    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 supportZambon SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZambon S.p.A.
    B.5.2Functional name of contact pointDearbhla Hull
    B.5.3 Address:
    B.5.3.1Street AddressVia Lillo del Duca, 10
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20091
    B.5.3.4CountryItaly
    B.5.4Telephone number00441243859016
    B.5.5Fax number00441243859016
    B.5.6E-mailclinicaltrials@zambongroup.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.2.1.1.1Trade name Promixin
    D.2.1.1.2Name of the Marketing Authorisation holderZambon SPA
    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 nameColistimethate sodium
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder for nebuliser 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.3.9.1CAS number 8068-28-8
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameColistimethate Sodium
    D.3.9.4EV Substance CodeSUB06801MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000
    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) Yes
    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 Salbutamol-ratiopharm® N metered-dose aerosol inhaler
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSalbutamol-ratiopharm® N metereddose aerosol inhaler
    D.3.2Product code [Salbutamol]
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 INNSALBUTAMOL
    D.3.9.1CAS number 18559-94-9
    D.3.9.2Current sponsor codeSalbutamol
    D.3.9.3Other descriptive nameSalbutamol
    D.3.9.4EV Substance CodeSUB10422MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNebuliser solution
    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
    Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
    Bronchiectasie non da fibrosi cistica con infezione cronica da Pseudomonas aeruginosa (P.aeruginosa)
    E.1.1.1Medical condition in easily understood language
    Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
    Bronchiectasie non da fibrosi cistica con infezione cronica da Pseudomonas aeruginosa (P.aeruginosa)
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10006445
    E.1.2Term Bronchiectasis
    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 the trial is to investigate the effect of the use of inhaled colistimethate sodium, administered twice daily via the I-neb for 12 months, compared to placebo in subjects with NCFB chronically
    infected with P. aeruginosa on the frequency of pulmonary exacerbations.
    L’obiettivo primario della sperimentazione è quello di valutare l'effetto dell'uso di colistimetato sodico per via inalatoria, somministrato due volte al giorno tramite l'I-neb per 12 mesi, rispetto al placebo in soggetti con
    bronchiectasie non da fibrosi cistica (non–cystic fibrosis bronchiectasis, NCFB) con infezione cronica da P. aeruginosa sulla frequenza delle riacutizzazioni polmonari.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to investigate the effect of the use of inhaled colistimethate sodium, administered twice daily via the I-neb for 12 months compared to placebo in subjects with NCFB chronically
    infected with P. aeruginosa, on:
    - the time to the first pulmonary exacerbation
    - the number of exacerbation-free days
    - the severity of pulmonary exacerbations
    - the time to the first severe pulmonary exacerbation
    - the Quality of Life
    - the pharmaco-economic effect
    - the density and susceptibility of P. aeruginosa and to investigate the
    emergence of other bacterial colonies and any developing resistance
    - the safety and tolerability of inhaled colistimethate sodium
    Gli obiettivi secondari mirano da investigare gli effetti dell'utilizzo dell'IMP attraverso I-Neb per 12 mesi, comparati con il placebo in soggetti con NCFB con infezione cronica da P. aeurginosa:
    - il tempo fino alla prima riacutizzazione polmonare
    - il numero di giorni senza riacutizzazione polmonare
    - la gravità delle riacutizzazioni polmonari
    - il tempo fino alla prima riacutizzazione polmonare grave
    - la qualità della vita
    - gli effetti farmacoeconomici
    - la densità e la suscettibilità di P.aeruginosa così come investigare l'insorgenza di altre colonie batteriche e lo sviluppo di resistenza
    - la sicurezza e la tollerabilità di colistimetato di sodio per via inalatoria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) are able and willing to give informed consent, following a detailed
    explanation of participation in the protocol and signed consent obtained;
    2) are aged 18 years or older of either gender;
    3) are diagnosed with NCFB by CT (or high-resolution CT) as recorded in the subject's notes and this is their predominant condition being
    treated;
    4) had at least 2 NCFB pulmonary exacerbations requiring oral or
    inhaled antibiotics or 1 NCFB pulmonary exacerbation requiring
    intravenous antibiotics in the 12 months preceding the Screening Visit
    (Visit 1) and had no NCFB pulmonary exacerbation with or without
    treatment during the period between Visit 1 and Visit 2;
    5) have a documented history of P. aeruginosa infection;
    6) are clinically stable and have not required a change in pulmonary
    treatment for at least 30 days before the Screening Visit (Visit 1);
    7) have pre-bronchodilator FEV1 =25% of predicted;
    8) had a positive sputum culture for P. aeruginosa from an adequate
    sample taken at the Screening Visit (Visit 1) or during the screening
    period.
    I soggetti sono idonei se:
    1. sono in grado e disposti a fornire il consenso informato dopo una
    spiegazione dettagliata della partecipazione nel protocollo e aver
    firmato il consenso ottenuto;
    2. sono di età pari o superiore a 18 anni di entrambi i sessi;
    3. hanno ricevuto una diagnosi di NCFB mediante tomografia
    computerizzata (TC) o TC ad alta risoluzione (high-resolution CT,
    HRCT) come registrato nelle note del soggetto, e questa è la loro
    condizione predominante oggetto di trattamento;
    4. hanno manifestato almeno 2 riacutizzazioni polmonari di NCFB che
    hanno richiesto antibiotici per via orale o per inalazione o 1
    riacutizzazione polmonare di NCFB che ha richiesto antibiotici per via
    endovenosa nei 12 mesi precedenti la Visita di screening (Visita 1) e
    non hanno manifestato alcuna riacutizzazione polmonare di NCFB con
    o senza trattamento nel periodo tra la Visita 1 e Visita 2;
    5. hanno un’anamnesi documentata di infezione da P. aeruginosa;
    6. sono clinicamente stabili e non hanno avuto necessità di una modifica
    del trattamento polmonare per almeno 30 giorni prima della Visita di
    screening (Visita 1);
    7. hanno un volume espiratorio massimo nel primo secondo (Forced
    Expiratory Volume in the 1st second, FEV1) pre-broncodilatatore =25%
    del predetto;
    8. positività per P. aeruginosa dell’esame colturale di un campione
    adeguato di espettorato prelevato alla Visita di Screening (Visita 1) o
    durante il periodo di screening.
    E.4Principal exclusion criteria
    Subjects are not eligible for the trial if they meet one or more of the
    exclusion criteria listed below:
    1) known bronchiectasis as a consequence of cystic fibrosis (CF);
    2) known history of hypogammaglobulinaemia requiring treatment with
    immunoglobulin, unless fully replaced and considered immunocompetent
    by the Investigator;
    3) myasthenia gravis or porphyria;
    4) severe cardiovascular disease such as severe uncontrolled
    hypertension, ischaemic heart disease or cardiac arrhythmia and any
    other conditions that would confound the evaluation of safety, in the
    opinion of the Investigator;
    5) had major surgery in the 3 months prior to the Screening Visit (Visit
    1) or planned inpatient major surgery during the study period;
    6) receiving treatment for ABPA;
    7) had massive haemoptysis (greater than or equal to 300 mL or
    requiring blood transfusion) in the preceding 4 weeks before the
    Screening Visit (Visit 1) or between Visit 1 and Visit 2;
    8) respiratory failure that would compromise patient safety or
    confound the evaluation of safety or efficacy of the study in the opinion
    of the Investigator;
    9) current active malignancy, except for basal cell carcinoma or
    squamous cell carcinoma of the skin without metastases;
    10) taking immunosuppressive medications (such as azathioprine,
    cyclosporine, tacrolimus, sirolimus, mycophenolate, rituximab), and/or
    anti-cytokine medications (such as anti-IL-6 and anti-tumour alpha
    necrosis factor products) in the preceding year before the Screening
    Visit (Visit 1);
    11) known history of human immunodeficiency virus (HIV);
    12) current treatment for non-tuberculous mycobacterial (NTM) lung
    disease or tuberculosis;
    13) known or suspected to be allergic or unable to tolerate
    colistimethate sodium (intravenous or inhaled) or other polymixins,
    including evidence of bronchial hyper-reactivity following inhaled
    colistimethate sodium;
    14) treatment with long term (= 30 days) prednisone at a dose of
    greater than 15 mg a day (or equivalent dose of any other
    corticosteroid) within six months of the Screening Visit (Visit 1);
    15) new maintenance treatment with any oral macrolides (e.g.
    azithromycin/erythromycin/clarithromycin) within 30 days of the
    Screening Visit (Visit 1) or started between Visit 1 and Visit 2;
    16) use of any intravenous or intramuscular or oral or inhaled antipseudomonal
    antibiotic (except chronic macrolides with a stable dose) within 30 days prior to the Screening Visit (Visit 1) and between Visit 1
    and Visit 2;
    17) pregnant or breast-feeding or plan to become pregnant over the
    next year or of child-bearing potential and unwilling to use a reliable
    method of contraception for at least one month before randomisation
    and throughout their involvement in the trial;
    I soggetti non sono idonei se:
    1. hanno bronchiectasie note come conseguenza della fibrosi cistica (FC);
    2. hanno anamnesi nota di ipogammaglobulinemia che richiede un
    trattamento con immunoglobulina, a meno che non sia interamente
    sostituita e siano considerati immunocompetenti dallo Sperimentatore;
    3. hanno miastenia gravis o porfiria;
    4. hanno una grave malattia cardiovascolare, quale ipertensione grave
    non controllata, cardiopatia ischemica o aritmia cardiaca ed eventuali
    altre condizioni che potrebbero confondere la valutazione della
    sicurezza, secondo l’opinione dello Sperimentatore;
    5. hanno subito un intervento di chirurgia maggiore nei 3 mesi precedenti
    la Visita di screening (Visita 1)
    1) o hanno in programma un intervento di chirurgia maggiore in regime di
    ricovero ospedaliero durante il periodo dello studio;
    6. stanno ricevendo un trattamento per aspergillosi broncopolmonare
    allergica (allergic bronchopulmonary aspergillosis, ABPA);
    7. hanno manifestato un’emottisi massiva (pari o superiore a 300 ml o che
    richieda una trasfusione di sangue) nelle precedenti 4 settimane prima
    della Visita di screening (Visita 1) o tra la Visita 1 e la Visita 2;
    8. hanno insufficienza respiratoria che comprometterebbe la sicurezza del
    paziente o confonderebbe la valutazione della sicurezza o dell'efficacia
    dello studio secondo l’opinione dello Sperimentatore;
    9. hanno un’attuale neoplasia maligna attiva, fatta eccezione per il
    carcinoma a cellule basali o carcinoma a cellule squamose della pelle senza metastasi;
    10. hanno assunto farmaci immunosoppressori (come azatioprina,
    ciclosporina, tacrolimus, sirolimus, micofenolato, rituximab) e/o farmaci
    anticitochine (come agenti anti IL-6 e prodotti anti-fattore di necrosi
    tumorale alfa) nell’anno precedente la Visita di screening (Visita 1);
    11. hanno anamnesi nota di infezione da virus dell’immunodeficienza umana
    (human immunodeficiency virus, HIV);
    12. stanno assumendo un trattamento attuale per malattia polmonare
    micobatterica non tubercolotica (non-tuberculous mycobacteria, NTM)
    o tubercolosi;
    13. sono soggetti allergici noti o sospetti o non in grado di tollerare il
    colistimetato di sodio (per via endovenosa o per via inalatoria) o altre
    polimixine, compresa evidenza di iperreattività bronchiale in seguito a
    inalazione di colistimetato di sodio;
    14. assumono un trattamento a lungo termine (=30 giorni) con prednisone
    a una dose superiore a 15 mg al giorno (o dose equivalente di un
    qualsiasi altro corticosteroide) entro sei mesi dalla Visita di screening
    (Visita 1);
    15. assumono un nuovo trattamento di mantenimento con qualsiasi
    macrolide per via orale (ad es. azitromicina/eritromicina/claritromicina)
    iniziato entro 30 giorni dalla Visita di screening (Visita 1) o iniziato tra la
    Visita 1 e la Visita 2;
    16. fanno uso di qualsiasi antibiotico antipseudomonas per via endovenosa
    o intramuscolare o per via orale o per inalazione (ad eccezione
    dell’utilizzo cronico di macrolidi con una dose stabile) nei 30 giorni
    precedenti la Visita di screening (Visita 1) e tra la Visita 1 e la Visita 2;
    17. sono in gravidanza o allattamento o stanno pianificando una gravidanza
    nel corso del prossimo anno o sono in età fertile e non desiderano usare
    un metodo contraccettivo affidabile per almeno un mese prima della
    randomizzazione e durante tutto il loro coinvolgimento nella
    sperimentazione;
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable for this trial is the mean annual NCFB pulmonary exacerbation rate.
    Tasso annuale medio di riacutizzazioni polmonari.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Along the study.
    Durante lo studio.
    E.5.2Secondary end point(s)
    1. time (in days) from the first dose of IMP until the first pulmonary
    exacerbation;
    2. annualised number of pulmonary exacerbation-free days;
    3. number of severe pulmonary exacerbations defined as those requiring
    intravenous antibiotics and/or hospitalisation;
    4. the time (in days) from the first does of IMP until the first severe
    pulmonary exacerbation;
    5. QoL as measured by the total scores of the SGRQ and QOL-B
    questionnaires as well as changes in SGRQ and QOL-B from baseline to
    each post-baseline visit;
    ¿ il tempo (in giorni) dalla prima dose di IMP fino alla prima
    riacutizzazione polmonare;
    ¿ numero annualizzato di giorni senza riacutizzazioni polmonari;
    ¿ numero di riacutizzazioni polmonari gravi, definite come quelle che
    richiedono antibiotici per via endovenosa e/o ricovero in ospedale;
    ¿ il tempo (in giorni) dalla prima dose di IMP fino alla prima
    riacutizzazione polmonare grave;
    ¿ qualità della vita (quality of life, QoL) misurata mediante il punteggio
    totale del Questionario respiratorio di Saint George (Saint George’s
    Respiratory Questionnaire, SGRQ) e del Questionario sulla qualità
    della vita – Bronchiectasia (Quality of Life – Bronchiectasis, QOL-B),
    nonché variazioni nel punteggio SGRQ e QOL-B dal basale in
    occasione di ciascuna visita post-basale;
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 from first dose until first pulmonary exacerbation
    2 and 3 along the study
    4 from first does until first severe pulmonary exacerbation
    5 from baseline to each post-baseline visit
    6 along the study
    7 from baseline (Visit 2) to Day28 (Visit 3) and to Visits 5 & 7
    1 dalla prima dose alla riacutizzazione polmonare.
    2 e 3 durante lo studio
    4 dalla prima dose fino alla prima riacutizzazione polmonare grave
    5 dalla baseline ad ogni visita successiva alla baseline.
    7 dalla baseline (Visita 2) al giorno 28 (Visita 3) e alla visita 5 e 7
    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) 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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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 Information not present in EudraCT
    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
    Canada
    France
    Italy
    Poland
    United States
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 208
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 420
    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)
    After the end of the study the patient will return to standard treatment.
    I pazienti torneranno ai loro trattamenti standard.
    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 Decision2020-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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