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    The EU Clinical Trials Register currently displays   37978   clinical trials with a EudraCT protocol, of which   6230   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-003052-36
    Sponsor's Protocol Code Number:19067
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-003052-36
    A.3Full title of the trial
    Triple Modality Functional Magnetic Resonance Lung Imaging in Cystic Fibrosis and Non-CF Bronchiectasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Magnetic Resonance Imaging (MRI) in Bronchiectasis
    A.3.2Name or abbreviated title of the trial where available
    MRI in Bronchiectasis
    A.4.1Sponsor's protocol code number19067
    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 SponsorThe University of Nottingham
    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 supportNIHR Senior Investigator Award
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe University of Nottingham
    B.5.2Functional name of contact pointAngela Shone
    B.5.3 Address:
    B.5.3.1Street AddressResearch and Innovation
    B.5.3.2Town/ cityUniversity of Nottingham,Jubilee Conference Centre
    B.5.3.3Post codeNG8 1DB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0115 8467906
    B.5.5Fax number0115 9513633
    B.5.6E-mailsponsor@nottingham.ac.uk
    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 hyperpolarized xenon-129
    D.2.1.1.2Name of the Marketing Authorisation holderSir Peter Mansfield Imaging Centre (SPMIC)
    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 namehyperpolarized xenon-129
    D.3.4Pharmaceutical form Medicinal gas, liquefied
    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.3.9.4EV Substance CodeAS1
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product typeInhaled noble gas
    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
    Cystic fibrosis (CF)
    Non-CF Bronchiectasis
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis and bronchiectasis are diseases that can both affect the lungs, leading to recurrent chest infections and lung scarring.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10006445
    E.1.2Term Bronchiectasis
    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 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We plan to assess the value of novel MRI techniques to image the lungs of people with CF and bronchiectasis. Our main aims are to see how they compare to current measurements of lung function/structure and check that they give us useful information. Overall, we hope to identify the best MRI scanning methods for assessment of these lung diseases and employ those techniques in future clinical trials.

    In CF, there is great interest in newer treatments that can improve lung function. At present, we use relatively simple measures such as blowing tests to assess and monitor the efficacy of these therapies. These measurements may not always be sensitive enough to detect changes in the lungs, so newer tests that are more sensitive are required. The lung disease in bronchiectasis is similar to CF and so studying both patient groups will highlight the utility of lung MRI in a broader population.

    Following this study, we aim to run a clinical trial that will use our lung MRI scanning expertise
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess how feasible the different types of MRI scans are for our participants and check how consistent the scans are between different study visits.

    We will perform different types of MRI scans and what we learn about participant comfort/tolerability as well as imaging quality will greatly assist in the design of future lung MRI studies. We are not sure how much the different MRI scans will change when repeated over time. As such, we will invite participants to be scanned on multiple occasions and then compare their lung images longitudinally.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Project title: An integrated omics approach to characterise the microbiome of the Cystic Fibrosis airways
    Anticipated start date - January 2020
    Objective: To characterise the CF microbiome using 16S rRNA gene sequencing, metagenomics, metabolomics and metatranscriptomics.
    E.3Principal inclusion criteria
    For this study, eligibility criteria have been separated into workstreams as follows:
    Workstream 1 – Adult Healthy Volunteers
    Workstream 2 – Adults with CF
    Workstream 3 – Adults with Bronchiectasis
    Workstream 4 – Children aged 12 to less than 16 years with CF

    Workstream 1 Inclusion criteria:
    (Adult Healthy Volunteers)
    • Aged 16 years and over
    • For women, a negative urinary pregnancy test at screening and study visits
    • No significant respiratory disease or other significant medical condition within the last year

    Workstreams 2 and 3 Inclusion criteria:
    (Adults with diagnosed Cystic Fibrosis or non-CF Bronchiectasis)
    • Aged 16 years and over
    • For women, a negative urinary pregnancy test at screening and study visits
    • Diagnosis of cystic fibrosis by a respiratory physician (workstream 2) or bronchiectasis by computer tomography (CT) scan or a respiratory physician (workstream 3)
    • Clinically stable as defined by respiratory care team

    Workstream 4 Inclusion criteria:
    (Paediatric patients with diagnosed Cystic Fibrosis)
    • Parent or legal guardian able to give informed consent
    • Aged 12 years to less than 16 years
    • For females of child bearing age, a negative urinary pregnancy test at screening and study visits
    • Diagnosis of cystic fibrosis by a paediatric respiratory physician
    E.4Principal exclusion criteria
    Workstream 1 Exclusion criteria:
    (Adult Healthy Volunteers)
    • Standard MRI exclusion criteria – a history of implanted / indwelling magnetically active material
    • Acute respiratory illness within 30 days of MRI
    • Subject has received an Investigational Medical Product (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
    • Subject not deemed fit enough to tolerate procedure
    • Subject deemed unsuitable by clinical investigator for other reasons

    Workstreams 2 and 3 Exclusion criteria:
    (Adults with diagnosed Cystic Fibrosis or non-CF Bronchiectasis)
    • Standard MRI exclusion criteria – a history of implanted / indwelling magnetically active material
    • A current pulmonary exacerbation considered to be of sufficient severity to prevent safe MRI scanning
    • Current infection or previous infection within the last 12 months with Burkholderia cepacia complex or Mycobacterium abscessus
    • Previous lung transplantation
    • Evidence of susceptibility to or established hypercapnic (type 2) respiratory failure
    • Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
    • Subject not deemed fit enough to tolerate procedure
    • Subject deemed unsuitable by clinical investigator for other reasons

    Workstream 4 Exclusion criteria:
    (Paediatric patients with diagnosed Cystic Fibrosis)
    • Standard MRI exclusion criteria – a history of implanted / indwelling magnetically active material
    • A current pulmonary exacerbation considered to be of sufficient severity to prevent safe MRI scanning
    • Current or previous infection/colonization with Burkholderia cepacia complex or Mycobacteria abscessus
    • Previous lung transplantation
    • Evidence of susceptibility to or established hypercapnic (type 2) respiratory failure
    • Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
    • Subject not deemed fit enough to tolerate procedure
    • Subject deemed unsuitable by clinical investigator for other reasons
    E.5 End points
    E.5.1Primary end point(s)
    Success of acquiring 129Xe, OE and UTE MRI lung images from patients with CF and non-CF Bronchiectasis and produce baseline data for these groups to inform future clinical studies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    We aim to have completed recruitment and imaging of all volunteers within 36 months of the start date of the study. The end of the study will be the last visit of the last participant. Other analysis will continue with a programme determined by the technology and software available and research findings.
    E.5.2Secondary end point(s)
    1) To assess the ability of participants of each group to adhere to the protocols, thus informing the study design of future trials

    2) To assess repeatability of MR outcomes across study visits for those subjects undertaking more than one MR scanning visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The same timepoints for both primary and secondary outcomes will be used (see above).
    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 No
    E.6.4Safety No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial0
    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 concerned2
    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
    The trial will end immediately after the last visit of the last subject undergoing the trial.
    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 days1
    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 days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 12 to less than 16 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Participants will not receive the imaging or lung clearance index interventions outside of this research project unless they are part of their routine clinical care.
    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 Decision2019-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-06
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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