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    Summary
    EudraCT Number:2015-002743-33
    Sponsor's Protocol Code Number:Z7224L01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-25
    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 number2015-002743-33
    A.3Full title of the trial
    A double-blind, placebo-controlled, multi-centre, 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, multi-centre, 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 1
    Promis 1
    A.4.1Sponsor's protocol code numberZ7224L01
    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/ cityMilan
    B.5.3.3Post code20091
    B.5.3.4CountryItaly
    B.5.4Telephone 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 Yes
    D.2.1.1.1Trade name Promixin/Tadim
    D.2.1.1.2Name of the Marketing Authorisation holderZambon S.p.A.
    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.3.1Product nameColistimethate sodium
    D.3.2Product code [-]
    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.3.8INN - Proposed INNCOLISTIMETHATE SODIUM
    D.3.9.1CAS number 8068-28-8
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive name-
    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 Ventolin¿ Evohaler¿
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline UK
    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.3.1Product nameVentolin
    D.3.2Product code [Ventolin]
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    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 codeVentolin® Evohaler
    D.3.9.3Other descriptive nameVentolin® Evohaler
    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 cisticacon infezione cronica da Pseudomonas aeruginosa
    E.1.1.1Medical condition in easily understood language
    Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
    bronchiectasie non da fibrosi cisticacon infezione cronica da Pseudomonas 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 dello studio è quello di determinare l’effetto dell’uso del colistimetato di sodio per via inalatoria, somministrato due volte al giorno attraverso il dispositivo I-neb per 12 mesi,
    rispetto al placebo in soggetti con bronchiectasie non da fibrosi cistica con infezione cronica (NCFB) da P. Aeruginosa sulla frequenza delle riacutizzazioni polmonari.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial 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 NCFB pulmonary exacerbation;- to investigate the effect of the use of inhaled colistimethate sodium,administered twice daily via the I-neb for 12 months, on the number of exacerbation-free days; - number of severe NCFB pulmonary exacerbations, defined as those requiring intravenous antibiotics and/or hospitalisation;- the time to the first NFCB severe pulmonary exacerbation;- Quality of Life;- pharmaco-economic evaluation;- P. aeruginosa density and susceptibility and the emergence of other bacterial colonies and any developing resistance to colistin;- Overall safety and tolerability
    Gli obiettivi secondari principali sono: tempo all’insorgenza della riacutizzazione polmonare, numero di giorni senza riacutizzazioni,esiti correlati alla salute riferiti dai pazienti,valutazioni microbiologiche, valutazioni economiche farmaceutiche, oltre alla sicurezza e tollerabilità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects can be included in the trial if they meet all the inclusion criteria listed below: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)diagnosed with NCFB by computerised tomography (CT) or high resolution CT (HRCT) as recorded in the subject's notes;4)had at least 2 NCFB pulmonary exacerbations requiring oral 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 =30% of predicted; 8) had a positive sputum culture for P. aeruginosa from an adequate sample taken at the Screening Visit (Visit 1).
    I soggetti sono idonei se:
    1. sono in grado di fornire il consenso informato e sono disposti a farlo, a seguito di una spiegazione dettagliata della partecipazione al protocollo, e forniscono il loro consenso
    firmato; 2. sono soggetti di ogni sesso di età uguale o maggiore a 18 anni; 3. hanno ricevuto una diagnosi di NCFB attraverso tomografia computerizzata (TC) o TC ad alta risoluzione (HRCT) registrata nelle note del soggetto;4. hanno avuto almeno 2 riacutizzazioni polmonari delle NCFB che hanno richiesto antibiotici per via orale o 1 riacutizzazione polmonare delle NCFB che ha richiesto
    antibiotici per via endovenosa nei 12 mesi precedenti la visita di screening (Visita 1) e non hanno avuto riacutizzazioni polmonari di NCFB con o senza trattamento durante il periodo tra la Visita 1 e la Visita 2; 5. hanno una anamnesi documentata di infezione da P. Aeruginosa 6. sono clinicamente stabili e non hanno richiesto un cambiamento nel trattamento polmonare da almeno 30 giorni
    prima della visita di screening (Visita 1);7. hanno un FEV1 30% prima del broncodilatatore rispetto a quello previsto;8. hanno presentato una coltura dell'espettorato positiva per P. aeruginosa da un campione adeguato prelevato alla visita di screening (Visita 1).
    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, porphyria or myeloproliferative disease;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 allergic bronchopulmonary aspergillosis (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)predominant lung condition being chronic obstructive pulmonary disease (COPD), asthma or interstitial lung disease in the opinion of the Investigator;9)respiratory failure requiring long term oxygen therapy or noninvasive ventilation;10)current active malignancy, except for basal cell carcinoma of the skin without metastases;11)taking immunosuppressive medications (such as azathioprine,methotrexate, ciclosporine, tacrolimus, sirolimus, mycophenolate,rituximab), and/or anti-cytokine medications (such as anti IL-6 and antitumour alpha necrosis factor products) in the preceding year before the Screening Visit (Visit 1);12)known history of human immunodeficiency virus (HIV);13)current diagnosis or current treatment for non-tuberculous mycobacterium (NTM) pulmonary disease or Mycobacterium tuberculosis infection;14)known to be intolerant to inhaled beta-2 agonists (bronchodilators);15)known or suspected to be allergic or unable to tolerate colistimethate sodium (intravenous or inhaled) or other polymixins, including previous evidence of bronchial hyperreactivity following inhaled colistimethate sodium;16)treatment with long term (= 30 days) prednisone at a dose greater than 15 mg a day (or equivalent dose of any other corticosteroid) within six months of the Screening Visit (Visit 1);17)new maintenance treatment with oral macrolides (e.g. azithromycin/erythromycin/clarithromycin) started within 30 days of the Screening Visit (Visit 1) and between Visit 1 and Visit 2;18)use of any intravenous or intramuscular or oral or inhaled antipseudomonal antibiotic (except chronic oral macrolide treatment with a stable dose) within 30 days prior to the Screening Visit (Visit 1);19)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;20)significant abnormality in clinical evaluations and/or laboratory tests (physical examination, vital signs, haematology, clinical chemistry, clinically relevant impaired renal function, defined as serum creatinine levels =2.0x upper limit of normal, ECG) endangering the safe participation of the patient in the study at the Screening Visit (Visit 1)and during the study;21)participated in another investigational, interventional trial within 30 days prior to the Screening Visit (Visit 1);22)in the opinion of the Investigator not suitable for inclusion for whatever reason.
    I soggetti non sono idonei nei seguenti casi: 1. bronchiectasia nota derivante da fibrosi cistica (FC);2. anamnesi nota di ipogammaglobulinemia che ha richiesto un trattamento con immunoglobuline, se non completamente sostituita e considerata immuno-competente dallo Sperimentatore; 3. miastenia grave, porfiria, o malattia mieloproliferativa;4. malattie cardiovascolari gravi, come ipertensione grave non controllata, cardiopatia ischemica o aritmia cardiaca e altre condizioni che potrebbero confondere la valutazione della sicurezza, secondo il parere dello Sperimentatore;5. sono stati sottoposti a intervento chirurgico maggiore nei 3 mesi precedenti la visita di screening (Visita 1) o hanno un intervento chirurgico maggiore in regime di ricovero pianificato durante il periodo dello studio;6. stanno ricevendo un trattamento per aspergillosi broncopolmonare allergica (ABPA);7. hanno sperimentato un'emottisi massiva (maggiore o uguale a 300 mL o che ha necessitato di trasfusione di sangue) nelle 4 settimane prima della visita di screening (Visita 1) o tra la Visita 2 la Visita 2;8. presentano una malattia prevalentemente polmonare che, a giudizio dello sperimentatore, è identificabile con la broncopneumopatia cronica ostruttiva (BPCO), con l’asma o con la malattia interstiziale polmonare;9. insufficienza respiratoria che richiede ossigenoterapia o ventilazione non invasiva domiciliare a lungo termine;10. presentano una neoplasia attualmente attiva, fatta eccezione per il carcinoma a cellule basali della pelle senza metastasi;11. assumono farmaci immunosoppressori quali azatioprina,metotrexato, ciclosporina, tacrolimus, sirolimus,micofenolato, rituximab e/o farmaci anti-citochine (come i farmaci inibitori dell’interleuchina 6 (IL-6) e del fattore di
    necrosi tumorale alfa) nell’anno precedente prima della visita di screening (Visita 1);12. anamnesi nota di virus dell’immunodeficienza umana (HIV);13. diagnosi e trattamento in corso per malattia polmonare micobatterica non tubercolare (NTM) o infezione da Mycobacterium tuberculosis; 14. nota intolleranza ai beta-2 agonisti per via inalatoria
    (broncodilatatori);15. nota o sospetta allergia o impossibilità a tollerare il colistimetato di sodio (per via endovenosa o per inalazione) o altre polimixine, compresa precedente evidenza di iperreattività bronchiale a seguito dell’inalazione di colistimetato di sodio;16. trattamento a lungo termine (30 giorni) con prednisone a un dosaggio maggiore di 15 mg al giorno (o una dose equivalente di qualsiasi altro corticosteroide) entro 6 mesi dalla visita di screening 1 (Visita 1);17. nuovo trattamento di mantenimento con macrolidi orali (per es. azitromicina/eritromicina/claritromicina) iniziato entro 30
    giorni dalla visita di screening (Visita 1) o iniziato tra la Visita 1 e la Visita 2;18. uso di qualsiasi antibiotico anti-pseudomonas per via endovenosa o intramuscolare o orale o inalatoria (eccetto il trattamento con macrolidi orali a dose stabile) 30 giorni prima della visita di screening (Visita 1) e tra la Visita 1 e la Visita 2;19. gravidanza o allattamento in corso, gravidanza pianificata per l’anno seguente o soggetti in età fertile che non desiderano utilizzare un metodo affidabile di contraccezione per almeno un mese prima della randomizzazione e per l’intera durata della loro partecipazione allo studio;20. Anomalia significativa alle valutazioni cliniche e/o ai test di laboratorio (esame obiettivo, segni vitali, ematologia, chimica clinica, insufficienza renale clinicamente rilevante, definita come livelli sierici di creatinina 2,0 volte il limite superiore della norma, ECG), riscontrata alla visita di screening (Visita1) e durante lo studio, che compromette la sicurezza della partecipazione del paziente allo studio; 21. partecipazione a un altro studio clinico interventistico nei 30 giorni precedenti alla visita di screening (Visita 1);22. secondo il parere dello sperimentatore non sono adatti per l’inclusione per qualsiasi motivo.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Variable:
    Mean annual pulmonary exacerbation rate.
    Variabile di efficacia primaria:
    - Tasso medio annuo di riacutizzazioni polmonari
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 months
    At 12 months
    E.5.2Secondary end point(s)
    Efficacy Endpoints
    The secondary efficacy endpoints of this trial are: -annualised number of pulmonary exacerbation-free days;the number of NCFB pulmonary exacerbations requiring intravenous antibiotics or oral antibiotics;-the QoL as measured by the total scores of the SGRQ and QOL-B questionnaires;-the time to first NCFB pulmonary exacerbation (in days) and the yearly mean pulmonary
    exacerbation rate considering adherent subjects only(adherent subjects are defined as taking at least 80% of the prescribed therapy,according recordings by the I-neb logging system);-the P. aeruginosa density as determined by the mean change in log10 CFU/g sputum from baseline (Visit 2) to Day 28 of treatment (Visit 3) as well as to Visits 5 and 7.-The average number of hospitalizations for pulmonary exacerbations.-The number of subjects hospitalized for NCFB pulmonary exacerbations;-The number of days of work absence Safety Endpoints.The safety endpoints of this trial are:-the incidence of TEAEs;-the number of subjects experiencing bronchospasm clinically or spirometrically determined following IMP administration during clinic
    visit;-P. aeruginosa susceptibility to colistin at end of treatment (12 months [Visit 7]).-Haematology and clinical chemistry;-Physical examination and vital signs data;-12-lead Electrocardiogram.
    Variabili di efficacia secondarie:• tempo (in giorni), dalla prima dose di medicinale sperimentale (IMP) fino alla prima riacutizzazione polmonare delle NCFB;• numero di giorni all’anno senza esacerbazioni polmonari;• numero di riacutizzazioni polmonari di NCFB gravi definite come quelle richiedenti antibiotici per via endovenosa e/o il ricovero;• tempo (in giorni), dalla prima dose di IMP fino alla prima riacutizzazione polmonare grave;• qualità della vita (QoL), misurata attraverso il punteggio totale del questionario Saint George’s Respiratory Questionnaire (SGRQ) e del questionario Quality of Life-Bronchiectasis (QOL-B), nonché i cambiamenti occorsi nei questionari SGRQ e QOL-B rispetto al basale ad ogni visita successiva al basale; • numero di giorni di assenza dal lavoro a causa di riacutizzazioni polmonari;• densità di P. aeruginosa come determinato dalla variazione media nel log10 di unità formanti colonie (CFU)/g di espettorato dal basale (Visita 2) al giorno 28 di trattamento (Visita 3),nonché alle Visite 5 e 7. Variabili di sicurezza:• incidenza degli eventi avversi emergenti dal trattamento (TEAE);• cambiamenti assoluti del valore FEV1 predetto in percentuale dal basale (Visita 2) alla fine del trattamento (Visita 7);• numero di soggetti che hanno sperimentato un broncospasmo determinato clinicamente o spirometricamente in seguito alla somministrazione di IMP alla fine del trattamento;• resistenza di P. aeruginosa alla colistina solfato come determinato mediante test in vitro della suscettibilità su campione di espettorato dallo Screening (Visita 1) alla fine del trattamento (Visita 7), nonché su campione di espettorato dalle visite di riacutizzazione alle visite cliniche dovute a polmonite;• comparsa di altre colonie batteriche e di qualsiasi resistenza di sviluppo sul campione di espettorato dallo Screening (Visita 1) alla fine del trattamento (Visita7);•ematologia, chimica clinica e test di funzionalità renale;• dati dell'esame obiettivo e dei segni vitali;• elettrocardiogramma a 12 derivazioni.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy Endpoints
    ¿ yearly mean pulmonary exacerbation rate: from baseline to the End of the study
    ¿ number of pulmonary exacerbations requiring intravenous
    antibiotics..: from baseline to the End of the study
    ¿ QoL: from baseline (visit 2) to the End of the study
    Safety Endpoints
    ¿ incidence of TEAEs: from baseline to the End of the study
    ¿ the number of subjects experiencing bronchospasm ...: from baseline
    to the End of the study
    ¿ monitoring subjects' lung function: over the duration of the study by
    means of presalbutamol
    ¿ FEV1 and FVC measurements & physical/vital signs data: from baseline
    to the End of the study
    ¿ P. aeruginosa susceptibility to colistin: at End of the study
    ¿ Haematology, clinical chemistry & 12-ECG: at screening vist and at the
    end of the trial
    Efficacy Endpoints
    ¿ yearly mean pulmonary exacerbation rate: from baseline to the End of the study
    ¿ number of pulmonary exacerbations requiring intravenous
    antibiotics..: from baseline to the End of the study
    ¿ QoL: from baseline (visit 2) to the End of the study
    Safety Endpoints
    ¿ incidence of TEAEs: from baseline to the End of the study
    ¿ the number of subjects experiencing bronchospasm ...: from baseline
    to the End of the study
    ¿ monitoring subjects' lung function: over the duration of the study by
    means of presalbutamol
    ¿ FEV1 and FVC measurements & physical/vital signs data: from baseline
    to the End of the study
    ¿ P. aeruginosa susceptibility to colistin: at End of the study
    ¿ Haematology, clinical chemistry & 12-ECG: at screening vist and at the
    end of the trial
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Australia
    Israel
    New Zealand
    Belgium
    France
    Germany
    Greece
    Italy
    Netherlands
    Portugal
    Spain
    Switzerland
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months6
    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 months9
    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: 210
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 410
    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
    After the end of the study the patient will return to standard treatment
    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 Decision2017-02-21
    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 StatusCompleted
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