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    Summary
    EudraCT Number:2017-001040-35
    Sponsor's Protocol Code Number:D3250C00045
    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 number2017-001040-35
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Parallel Group, Placebo controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on Standard of Care Treatment (ANDHI)
    Studio di Fase 3b multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo per valutare la sicurezza e l'efficacia di benralizumab 30 mg per via sottocutanea in pazienti affetti da asma grave non controllabile con il trattamento standard (ANDHI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of Benralizumab in Patients with Severe Asthma Uncontrolled.
    A study to evaluate the effect of Benralizumab in Patients with Severe Asthma Uncontrolled.
    A.3.2Name or abbreviated title of the trial where available
    ANDHI
    ANDHI
    A.4.1Sponsor's protocol code numberD3250C00045
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03170271
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressVastra Malarehamnen 9
    B.5.3.2Town/ citySodertalje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.4Telephone number18772409479
    B.5.5Fax number000000
    B.5.6E-mailinformation.center@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namebenralizumab
    D.3.2Product code MEDI-563
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.9.3Other descriptive nameMEDI-563
    D.3.9.4EV Substance Code.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    severe uncontrolled asthma
    severe uncontrolled asthma
    E.1.1.1Medical condition in easily understood language
    Asthma (an illness that causes breathing difficulty) that is not fully controlled, so that episodes of breathing difficulty are still occurring despite the use of other available treatments
    Asthma (an illness that causes breathing difficulty) that is not fully controlled, so that episodes of breathing difficulty are still occurring despite the use of other available treatments
    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 LLT
    E.1.2Classification code 10049106
    E.1.2Term Asthma chronic
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 determine the effect of benralizumab on the rate of asthma exacerbations
    To determine the effect of benralizumab on the rate of asthma exacerbations
    E.2.2Secondary objectives of the trial
    To determine the effect of benralizumab on:
    - patient-reported disease-specific quality of life.
    - lung function.
    - patient-reported asthma control.
    - time to first asthma exacerbation.
    - lung function at home.
    - general quality of life and health status.
    To evaluate patient impression of overall asthma severity and change in the overall asthma status.
    To determine the effect of benralizumab on the patient's predominant symptoms and disease specific health-related quality of life in patients
    with doctor diagnosed chronic sinusitis with nasal polyposis.
    Safety Objective: To assess the safety and tolerability of benralizumab Exploratory Objectives:
    To determine the effect of:
    -eosinophil depletion with benralizumab on Biomarker components of known asthma inflammatory pathways or airway remodeling and Biomarker surrogates of eosinophilic inflammation/activation -benralizumab on the patient's level of asthma control based standard asthma guidance recommendations
    To determine the effect of benralizumab on:
    - patient-reported disease-specific quality of life.
    - lung function.
    - patient-reported asthma control.
    - time to first asthma exacerbation.
    - lung function at home.
    - general quality of life and health status.
    To evaluate patient impression of overall asthma severity and change in the overall asthma status.
    To determine the effect of benralizumab on the patient's predominant symptoms and disease specific health-related quality of life in patients
    with doctor diagnosed chronic sinusitis with nasal polyposis.
    Safety Objective: To assess the safety and tolerability of benralizumab Exploratory Objectives:
    To determine the effect of:
    -eosinophil depletion with benralizumab on Biomarker components of known asthma inflammatory pathways or airway remodeling and Biomarker surrogates of eosinophilic inflammation/activation -benralizumab on the patient's level of asthma control based standard asthma guidance recommendations
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Main objective: To assess the potential for benralizumab treated patients
    to reduce their standard of care asthma controller regimen while
    maintaining asthma control.
    Endpoint: Number of adapted GINA step category changes from Visit 15
    to the EOS Visit 27 (Day 560/Week 80).
    Other Objectives: To assess standard asthma efficacy measures for
    benralizumab treated patients who reduce their standard of care asthma
    controller regimen.
    Endpoints:
    -Change in continuous asthma efficacy measures (including ACQ6 and
    SGRQ) from Visit 15 to the EOS Visit 27 (Day 560/Week 80).
    -Change in continuous asthma efficacy measures (including ACQ6 and
    SGRQ) from Visit 4 to the EOS Visit 27 (Day 560/Week 80).
    -Clinically significant asthma exacerbations from Visit 15 to the EOS Visit
    27.
    Safety Objective: To assess the safety and tolerability of benralizumab
    during treatment period.
    Endpoint: AEs, physical examination, vital signs during the open label
    benralizumab treatment period (Visit 13 to Visit 27).

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Main objective: To assess the potential for benralizumab treated patients
    to reduce their standard of care asthma controller regimen while
    maintaining asthma control.
    Endpoint: Number of adapted GINA step category changes from Visit 15
    to the EOS Visit 27 (Day 560/Week 80).
    Other Objectives: To assess standard asthma efficacy measures for
    benralizumab treated patients who reduce their standard of care asthma
    controller regimen.
    Endpoints:
    -Change in continuous asthma efficacy measures (including ACQ6 and
    SGRQ) from Visit 15 to the EOS Visit 27 (Day 560/Week 80).
    -Change in continuous asthma efficacy measures (including ACQ6 and
    SGRQ) from Visit 4 to the EOS Visit 27 (Day 560/Week 80).
    -Clinically significant asthma exacerbations from Visit 15 to the EOS Visit
    27.
    Safety Objective: To assess the safety and tolerability of benralizumab
    during treatment period.
    Endpoint: AEs, physical examination, vital signs during the open label
    benralizumab treatment period (Visit 13 to Visit 27).
    E.3Principal inclusion criteria
    1.Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines.
    2.Female and male patients aged 18 to 75 years inclusively at the time of Visit 1 with a history of physician-diagnosed asthma
    requiring treatment with medium-to-high dose ICS plus asthma controller, for at least 12 months prior to Visit 1. Other acceptable
    asthma controllers include a long acting bronchodilator (LABA or long-acting muscarinic antagonists [LAMA]), a leukotriene
    inhibitor, theophylline preparations or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma
    control; maximum total daily dose 20 mg prednisone or equivalent).
    3.Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months prior
    to Visit 1; see inclusion criterion 2 for acceptable other asthma controllers.
    For ICS/LABA combination preparations, highest-strength maintenance doses approved in the given country will meet this criterion.
    If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS
    dose.
    4.History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples)
    that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving
    corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase of
    their maintenance dose.
    5.ACQ6 score =1.5 at Visit 1.
    6.Screening pre-bronchodilator (pre-BD) FEV1 of <80% predicted at Visit 2
    Note: Spirometry testing should only be performed if the patient meets the asthma medication hold for lung function testing (see
    Section 3.10.2), the test should be postponed to another day prior to Visit 3 to improve the chances of achieving a qualifying FEV1
    that is not affected by bronchodilator medication.
    7.Evidence of asthma as documented by airway reversibility (FEV1 =12%) demonstrated at Visit 2 or Visit 3.
    8.Peripheral blood eosinophil count of =300 cells/µL assessed by central laboratory at Visit 1 or Visit 2.

    Per la lista completa vedere il protocollo
    1. Il consenso informato scritto per la partecipazione allo studio deve essere ottenuto prima che vengano eseguite le procedure relative allo studio e secondo le linee guida internazionali e / o le linee guida dell'Unione Europea (UE) applicabili.
    2. pazienti donna o uomo di età tra 18 e 75 anni inclusi al momento della visita 1 con una storia di asma diagnosticata dal medico che richiedono un trattamento con ICS a dose medio-alta più controllore dell'asma, per almeno 12 mesi prima della visita 1. Accettabile anche: i controllori di asma includono un broncodilatatore a lunga durata d'azione, un leucotriene
    inibitore, preparazioni di teofillina o OCS di mantenimento (fabbisogno giornaliero o giornaliero di OCS per mantenere l'asma controllo; dose massima giornaliera totale di 20 mg di prednisone o equivalente).
    3. Trattamento corrente documentato con alte dosi giornaliere di ICS più almeno un altro controller di asma per almeno 3 mesi prima
    della visita 1. Per le preparazioni combinate ICS / LABA, le dosi di mantenimento ad alta resistenza approvate nel paese indicato soddisfano questo criterio.
    Se l'ICS e le altre terapie per il controllo dell'asma sono fornite da inalatori separati, il paziente deve essere sottoposto a un ICS giornaliero di dose elevata
    4. Storia di almeno 2 riacutizzazioni dell'asma mentre su ICS più un altro controllore di asma (vedere il criterio di inclusione 2 per gli esempi)
    che richiedeva un trattamento con corticosteroidi sistemici (IM, IV o orale) nei 12 mesi precedenti la visita 1. Per i pazienti che ricevevano
    corticosteroidi come terapia di mantenimento, il trattamento con corticosteroidi per l'esacerbazione è definito come un aumento temporaneo di
    la loro dose di mantenimento.
    5. Punteggio ACQ6 = 1,5 alla Visita 1.
    6.Screening pre-broncodilatatore (pre-BD) FEV1 <80% previsto alla visita 2
    Nota: il test spirometrico deve essere eseguito solo se il paziente incontra la sospensione del farmaco per l'asma per il test di funzionalità polmonare (vedere
    Sezione 3.10.2), il test deve essere posticipato a un altro giorno prima di Visit 3 per migliorare le possibilità di raggiungere un FEV1 qualificante
    questo non è influenzato dai farmaci broncodilatatori.
    7. Evidenza di asma documentata dalla reversibilità delle vie aeree (FEV1 =12%) dimostrata alla Visita 2 o Visita 3.
    8. Conteggio degli eosinofili periferici di =300 cellule / µL valutato dal laboratorio centrale alla Visita 1 o Visita 2.

    Per la lista completa vedere il protocollo
    E.4Principal exclusion criteria
    1. Malattia polmonare clinicamente importante diversa dall'asma o diagnosticata con malattia polmonare o sistemica, diversa dall'asma a cui sono associati elevati eosinofili periferici
    2. infezioni respiratorie superiori o inferiori entro 30 giorni prima della data in cui è stato ottenuto il consenso informato o durante il periodo di screening / run-in.
    3. Qualsiasi disturbo che secondo il PI: influenza la sicurezza del paziente durante lo studio, influenza i risultati degli studi e interpretazioni, impedisce al paziente di completare lo studio
    4. Storia nota di allergia o reazione a qualsiasi componente della formulazione IP.
    5. infezione parassitaria diagnosticata entro 24 settimane prima del consenso informato, non trattata o che non ha risposto a terapia standard
    6. Eventuali risultati anormali clinicamente significativi nell'esame fisico, segni vitali, ematologia o chimica clinica durante il periodo di screening
    7. malattia cardiaca significativa o anomalia ECG ottenuta durante lo screening / run-in
    periodo può mettere a rischio il paziente o interferire con le valutazioni dello studio.
    8. Storia di abuso di alcol o droghe nei 12 mesi precedenti alla data di acquisizione del consenso informato.
    9. storia di un noto disturbo di HIV
    10. Fumatori in corso o ex fumatori con una storia di fumo =10 anni . Un ex fumatore è definito come un paziente che ha smesso fumare a almeno 6 mesi prima della visita 1.
    11. Malignità corrente o storia di neoplasia, fatta eccezione per:
    I pazienti che hanno avuto tumori cutanei non-melanoma o carcinoma in situ della cervice sono ammissibili a condizione che il paziente sia remissione e la terapia curativa è stata completata almeno 12 mesi prima della data in cui è stato ottenuto il consenso informato.
    I pazienti che hanno avuto altre neoplasie sono eleggibili a condizione che il paziente sia in remissione e che la terapia sia curativa completata almeno 5 anni prima della data di acquisizione del consenso informato.
    12. Uso approvato o off-label di immunosoppressivi sistemici entro 3 mesi prima della data del consenso informato. Questi includono ma non sono limitati a piccole molecole: metotrexato, ciclosporina, azatioprina e immunosoppressivi / immunomodulanti biologici come bloccanti del TNF. Uso regolare di corticosteroidi orali, sono esclusi, tranne che per l'indicazione di asma.
    13. Non sono consentiti prodotti concorrenti per l'asma, ad eccezione dell'immunoterapia allergica stabile (definita come una dose stabile e
    regime al momento della visita 1). Periodi di washout accettabili per altri farmaci biologici per l'asma:
    Altri prodotti per l'abbassamento di eosinofili indicati per l'asma (incluso
    mepolizumab o reslizumab): almeno 4 mesi. Uso preuso di omalizumab: almeno 1 mese.
    14. ricezione precedente di benralizumab (MEDI-563).
    15. Ricevimento di qualsiasi farmaco sperimentale come parte di uno studio di ricerca entro circa 5 emivite prima della randomizzazione.

    Per la lista completa vedere il protocollo
    1.Clinically important pulmonary disease other than asthma or ever been
    diagnosed with pulmonary or systemic disease, other than asthma, that
    are associated with elevated peripheral eosinophil counts
    2.Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
    3.Any disorder that is not stable in the opinion of the Investigator and could: Affect the safety of the patient throughout the study. Influence the findings of the studies or their interpretations.
    Impede the patient's ability to complete the entire duration of study.
    4.Known history of allergy or reaction to any component of the IP formulation.
    5.A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been
    treated with, or has failed to respond to, standard of care therapy.
    6.Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during screening period
    7.Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in
    period, which in
    the opinion of the Investigator may put the patient at risk or interfere with study assessments.
    8.History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
    9.A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
    10.Current smokers or former smokers with a smoking history of =10 pack years. A former smoker is defined as a patient who quit
    smoking at
    least 6 months prior to Visit 1.
    11.Current malignancy, or history of malignancy, except for:
    Patients who have had non-melanoma skin cancers or in situ carcinoma of the cervix are eligible provided that the patient is in
    remission and
    curative therapy was completed at least 12 months prior to the date informed consent is obtained.
    Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was
    completed at least 5
    years prior to the date informed consent is obtained.
    12.Approved or off-label use of systemic immunosuppressive
    medications within 3 months prior to the date informed consent is obtained. These include but are not limited to small molecules
    such as
    methotrexate, cyclosporine, azathioprine, and
    immunosuppressive/immunomodulating biologics such as tumor necrosis factor (TNF) blockers. Regular use of systemic (oral)
    corticosteroids is also excluded except for the indication of asthma.
    13.Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and
    regimen at the time of Visit 1). Acceptable washout periods for other asthma biologics:
    Other eosinophil lowering products indicated for asthma (including
    mepolizumab or reslizumab): at least 4 months.Prior omalizumab use: at least 1 month.
    14.Previously received benralizumab (MEDI-563).
    15.Receipt of any investigational medication as part of a research study within approximately 5 half-lives prior to randomization.

    Per la lista completa vedere il protocollo
    E.5 End points
    E.5.1Primary end point(s)
    The annualized rate of asthma exacerbations between benralizumab and placebo.
    The annualized rate of asthma exacerbations between benralizumab and placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment period of 24 weeks.
    Treatment period of 24 weeks.
    E.5.2Secondary end point(s)
    The change from baseline (Visit 4) in Saint George Respiratory Questionnaire (SGRQ) to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) in forced expiratory volume in first second (FEV1) over the treatment period (up to and including Day 168/Week 24).
    The change from baseline (Visit 4) in Asthma Control Questionnaire 6 (ACQ6) to the EOT (Day 168/Week 24).
    Time to first asthma exacerbation (treatment period 24 weeks).
    The change from run-in baseline morning peak expiratory flow (PEF) to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) SF 36v2 to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) in PGI-S to the EOT (Day 168/Week 24).
    The degree of change reported by the patient (PGI-C) and Investigator (CGI-C) expressed as a proportion of each of the 7 possible responses to the EOT (Day 168/Week 24). The degree of change reported by the patient in their predominant
    symptom to the EOT (Day 168/Week 24).
    The change from baseline (Visit 3) in the sino-nasal outcome test (SNOT-22) score to the EOT (Day 168/Week 24).
    Safety: Adverse events (AEs), laboratory variables, physical examination.
    Exploratory:
    The change from baseline (Visit 4) in circulating biomarkers to each prespecified scheduled assessment during the treatment period.
    The proportion of time that that the patient's asthma is well-controlled based on composite diary measures.
    The change from baseline (Visit 4) in Saint George Respiratory Questionnaire (SGRQ) to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) in forced expiratory volume in first second (FEV1) over the treatment period (up to and including Day 168/Week 24).
    The change from baseline (Visit 4) in Asthma Control Questionnaire 6 (ACQ6) to the EOT (Day 168/Week 24).
    Time to first asthma exacerbation (treatment period 24 weeks).
    The change from run-in baseline morning peak expiratory flow (PEF) to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) SF 36v2 to the EOT (Day 168/Week 24).
    The change from baseline (Visit 4) in PGI-S to the EOT (Day 168/Week 24).
    The degree of change reported by the patient (PGI-C) and Investigator (CGI-C) expressed as a proportion of each of the 7 possible responses to the EOT (Day 168/Week 24). The degree of change reported by the patient in their predominant
    symptom to the EOT (Day 168/Week 24).
    The change from baseline (Visit 3) in the sino-nasal outcome test (SNOT-22) score to the EOT (Day 168/Week 24).
    Safety: Adverse events (AEs), laboratory variables, physical examination.
    Exploratory:
    The change from baseline (Visit 4) in circulating biomarkers to each prespecified scheduled assessment during the treatment period.
    The proportion of time that that the patient's asthma is well-controlled based on composite diary measures.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline (Visit 4) to EOT (Day 168/ Week 24).
    Throughout 24 week treatment period.
    From Baseline (Visit 4) to EOT (Day 168/ Week 24).
    Throughout 24 week treatment period.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Exploratory Biomarkers.
    Exploratory Biomarkers.
    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 Yes
    E.8.1.7.1Other trial design description
    Double blind for 24 week period. Patients can then be enrolled in 56 week open label sub study.
    Double blind for 24 week period. Patients can then be enrolled in 56 week open label sub study.
    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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA118
    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
    Canada
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    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
    The last visit of the last patient undergoing the study. The final study visit will be the telephone FU Visit.
    The last visit of the last patient undergoing the study. The final study visit will be the telephone FU Visit.
    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 months7
    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: 567
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 630
    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)
    See protocol. Patient will return to Standard of Care.
    See protocol. Patient will return to Standard of Care.
    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 Decision2017-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-18
    P. End of Trial
    P.End of Trial StatusCompleted
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