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    Summary
    EudraCT Number:2017-003665-10
    Sponsor's Protocol Code Number:RBH2017/001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-003665-10
    A.3Full title of the trial
    A single-centre study of the relationship between eosinophil activation and the lung microbiome in severe eosinophilic asthma (SEA) and the effect of benralizumab on these factors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Benralizumab and lung micro-organisms (BALM)
    A.3.2Name or abbreviated title of the trial where available
    Benralizumab and the lung microbiome (BALM)
    A.4.1Sponsor's protocol code numberRBH2017/001
    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 SponsorRoyal Brompton and Harefield NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Fasenra
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFasenra
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Eosinophilic Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma which requires high-dose treatments to maintain disease control (or which remains uncontrolled despite this), with evidence of inflammation involving eosinophils (a type of white blood cell)
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10068462
    E.1.2Term Eosinophilic asthma
    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
    To measure the change in the numbers of eosinophils (a subtype of white blood cells) in the lung tissue of patients with severe eosinophilic asthma, before and after three injections of 30mg of benralizumab (a newly-approved medicine for asthma that at a higher dose has been shown to markedly reduce the numbers of eosinophils) administered every 4 weeks.
    E.2.2Secondary objectives of the trial
    - To measure the change in lung function tests in the above patient population
    - To measure the change in asthma symptom control in the above patient population
    - To measure the change in Fractional exhaled Nitric Oxide (FeNO, a marker of lung inflammation) in the above patient population
    - To measure the change in detectable upper and lower airway inflammation and homogeneity of airways ventilation (the distribution of air when it is breathed in and out of the lungs) in the above patient population
    - To measure the baseline lung and nasal microbiome (i.e. the bacteria and fungi that live in the lungs) in SEA, and the effect of benralizumab on this microbiome
    - To conduct intensive culture of bronchial brushes pre and post treatment to obtain a bank of bacterial isolates from a subset of patients
    - To aim to profile relevant epigenetic markers (i.e. markers which tell us whether or not a particular gene is 'switched on' or 'switched off')
    - To culture and bank primary epithelial cells
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Age 18-75 years
    2. Weight ≥40kg
    3. Severe asthma as defined in the 2014 ERS/ATS severe asthma guideline
    4. Deemed eligible to commence benralizumab as NHS treatment according to NICE TA565
    5. FEV1 ≥ 60% predicted
    6. ACQ-6 >1.5.
    E.4Principal exclusion criteria
    Exclusion criteria:

    1. Significant cardiac disease, e.g. ischaemic heart disease, cardiac failure, permanent pacemaker
    2. Pregnant and breastfeeding
    3. Significant respiratory disease, other than the condition being studied, e.g. chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnoea requiring treatment.
    4. Current malignancy
    5. Current smokers (All subjects must be non-smokers or ex-smokers for at least 12 months with <10 pack-years smoking history.)
    6. Obesity (BMI>35kg/m2)
    7. Rheumatoid arthritis
    8. Confounding drugs (anti-asthma immune modulators other than steroids)
    9. Treatment with a monoclonal antibody in the last 6 months
    10. Known history of allergy or reaction to the study drug formulation, or history of anaphylaxis to any biologic therapy.
    11. Long-term systemic antibiotics/ antifungals, or any course(s) of systemic antibiotics/ antifungals within the past 2 weeks.
    12. Acute exacerbations of asthma (defined as a clinical episode requiring treatment with systemic corticosteroids, or requiring an increase in the dosage of systemic corticosteroids if the patient is on long term corticosteroid treatment) within the past 2 weeks
    13. History of an upper or lower respiratory infection (including common cold) within the past 2 weeks
    14. Female subjects who are pregnant/ breastfeeding/ less than 6 weeks post-partum at the time of enrolment, or who fulfil any of these criteria at any point prior to the final investigation (bronchoscopy)
    15. Previous bronchial thermoplasty in the last 48 months.
    16. Unable to provide written informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Numbers of eosinophils observed in bronchial biopsy after immunohistological staining (cells/mm2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    This end point will be evaluated at the end of the study
    E.5.2Secondary end point(s)
    - To measure the change in lung function tests in the above patient population
    - To measure the change in asthma symptom control in the above patient population
    - To measure the change in Fractional exhaled Nitric Oxide (FeNO, a marker of lung inflammation) in the above patient population
    - To measure the change in detectable upper and lower airway inflammation and homogeneity of airways ventilation (the distribution of air when it is breathed in and out of the lungs) in the above patient population
    - To measure the baseline lung and nasal microbiome (i.e. the bacteria and fungi that live in the lungs) in SEA, and the effect of benralizumab on this microbiome
    - To conduct intensive culture of bronchial brushes pre and post treatment to obtain a bank of bacterial isolates from a subset of patients
    - To aim to profile relevant epigenetic markers (i.e. markers which tell us whether or not a particular gene is 'switched on' or 'switched off')
    - To culture and bank primary epithelial cells from bronchial brushes (i.e. grow and store the cells that line the airway)
    - To measure the change in bronchial biopsy counts of other inflammatory cells in the above patient population

    Sample Biobank
    - To establish a sample biobank of biopsies, blood samples (for DNA, RNA and serum), and bacterial isolates and primary epithelial cells pre and post benralizumab administration in a subset of patients
    - Said Biobank will allow to allow further exploratory studies not limited to but including:
    *Sequencing of bacterial isolates (i.e. finding out the genetic code of the bacteria that are in the samples)
    *SNP genotyping (i.e. finding out the differences in genetic code in the samples)
    *global gene expression of biopsies (i.e. finding out all of the genes that are expressed in the biopsies)
    *metatranscriptomics of bronchial brushes (i.e. finding out all of the genes that are expressed in the brushes)
    *co-culture of bacterial isolates with primary epithelial cells (patient derived when feasible)
    E.5.2.1Timepoint(s) of evaluation of this end point
    These end points will be evaluated at the end of the study
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA0
    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 No
    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
    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 days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Subjects who take part in this study would be receiving benralizumab as part of their NHS care, so the decision of whether or not to continue benralizumab will be made by their care team in line with NICE guidance and will be based on whether or not benralizumab is clinically effective for them. This decision will be independent of whether or not they took part in this study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-25
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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