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    Summary
    EudraCT Number:2011-002038-37
    Sponsor's Protocol Code Number:5.0
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-29
    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 number2011-002038-37
    A.3Full title of the trial
    Hyperpolarised xenon magnetic resonance imaging (Xe-129 MRI) lung imaging in COPD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging of the lung with hyperpolarized xenon gas; investigations in patients with chronic obstructive pulmonary disease
    A.3.2Name or abbreviated title of the trial where available
    Xenon lung imaging in COPD: a COPD Cohort sub-study Version 1.0
    A.4.1Sponsor's protocol code number5.0
    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 SponsorUniversity of Oxford
    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 Oxford Biomedical Research Centre
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportGE Healthcare Ltd
    B.4.2CountryUnited Kingdom
    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 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 nameHyperpolarized xenon gas
    D.3.2Product code HypXe
    D.3.4Pharmaceutical form Medicinal gas, compressed
    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 INNHyperpolarized xenon gas
    D.3.9.2Current sponsor codeHypXe
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit l litre(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number99% pure
    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 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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Obstructive Pulmonary Disease
    E.1.1.1Medical condition in easily understood language
    Respiratory gas exchange disease that leads to breathlessness, also sometimes known as emphysema.
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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
    Our objective is to develop and use Xe-129 lung MRI, a regional non-ionising radiation based functional imaging tool for the evaluation of COPD. Specific aims are:
    (1) Technique development
    (2) Comparison to standard COPD assessment tools
    (3) Effects of salbutamol
    To test the effects of salbutamol on Xe-129 lung MRI imaging post -inhaled salbutamol
    (4) Interval imaging
    To evaluate the changes in Xe-129 lung MRI imaging occurring in patients over time.
    E.2.2Secondary objectives of the trial
    [All our objectives are included in the answer to question A10]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with a diagnosis of COPD, with at least mild disease (stage II – IV on GOLD criteria classification, FEV1 <80% predicted and FEV1/ FVC <70%25)
    • Significant smoking history (>15 pack years, where a pack year is the product of [average number of cigarettes smoked per day] and [number of years smoked for] divided by 20) or other definite cause of COPD
    • Patients over the age of 18 who are willing and able to give informed consent to participate in the study.
    E.4Principal exclusion criteria
    • Co-existent cardio-pulmonary disease that predominates over COPD and might confound results interpretation (for example asthma, bronchiectasis, cystic fibrosis, lung cancer, uncontrolled heart failure, frequent unstable angina, respiratory muscle weakness)
    • Other major co-morbidity such that life expectancy is less than 24 months due to a cause other than COPD
    • Pregnancy
    Exclusion criteria for CT scanning
    • Inability to lie flat
    Exclusion criteria for MR imaging
    • Inability to lie flat
    • Severe claustrophobia
    • Presence of a cardiac pace-maker or non-MRI compatible metallic implant
    • Intra-ocular foreign body
    • Epilepsy requiring on-going medical treatment, or a seizure within the past year

    Exclusion criteria for gadolinium enhanced lung MRI scanning
    • Known hypersensitivity/ allergy to the injection of MultiHance that is given as part of this scanning or an adverse reaction to an injection given during previous MRI scanning. MultiHance contains gadobenate dimeglumine and small quantities of benzyl alcohol.

    • Severe renal impairment
    Exclusion criteria for ventilation/perfusion nuclear medicine scanning
    • Known hypersensitivity to albumin or preference to avoid blood donation product

    Exclusion criteria for salbutamol intervention component of study
    • Known hypersensitivity to salbutamol or to any of the excipients
    • Inability to omit long acting bronchodilators for 24 hours prior to the start of the study, and short acting bronchodilators on the day of the study until measurements are complete.
    E.5 End points
    E.5.1Primary end point(s)
    Assessments to (1) further develop technical aspects of Xe-129 lung MRI, (2)compare with standard COPD assessment tools (3) evaluate changes in lung imaging post salbutamol (4) evaluate interval changes in imaging.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluations will take place at approximately three monthly intervals, but this will depend on the number of exacerbations that each patient has.
    E.5.2Secondary end point(s)
    See above in primary endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above in primary endpoints
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Imaging study
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States No
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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.1.1Number 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    The proposed trial is an observational study. As such all participants will receive best standard care throughout and this will continue without interference following trial completion.
    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 Decision2012-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-23
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