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    Summary
    EudraCT Number:2012-002792-34
    Sponsor's Protocol Code Number:Bronch
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-03-13
    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 number2012-002792-34
    A.3Full title of the trial
    Phenotyping bronchiectasis based on aetiology, exacerbation characteristics and response to erythromycin.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The characterisation of bronchiectasis over 2 years with a trial of a low dose antibiotic in the second year with the aim of identifying characteristics that mean people show the most improvement whilst on the drug.
    A.3.2Name or abbreviated title of the trial where available
    Phenotyping bronchiectasis over 2 years including a macrolide trial
    A.4.1Sponsor's protocol code numberBronch
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1131-6604
    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 Hospitals Leicester NHS 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 supportNIHR Leicester Respiratory Biomedical Research Unit, Glenfield Hospital
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospitals Leicester
    B.5.2Functional name of contact pointProfessor Andrew Wardlaw
    B.5.3 Address:
    B.5.3.1Street AddressGroby Road
    B.5.3.2Town/ cityGlenfield
    B.5.3.3Post codeLE3 9QP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01162583370
    B.5.6E-mailaw24@le.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 Yes
    D.2.1.1.1Trade name Erythromycin
    D.2.1.1.2Name of the Marketing Authorisation holderMilpharm Limited
    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 nameErythromycin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNErythromycin
    D.3.9.1CAS number 114-07-8
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250 to 250
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bronchiectasis
    E.1.1.1Medical condition in easily understood language
    Bronchiectasis is a condition of the lungs whereby there is inflammation, increased sputum production and recurrent chest infection. This results in a cycle of infection and further damage.
    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 16.1
    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
    Research tells us that erythromycin can reduce exacerbation frequency in bronchiectasis by greater than 50% with minimal side-effects. We know that this category of antibiotics (macrolides) can reduce sputum volume and improve quality of life by reducing lung inflammation rather than killing bacteria in a variety of different lung conditions. We also know from our own clinic data that in some patients a 3 month course of erythromycin can improve lung function by a considerable amount. The patients that improve the most have certain changes in the very small airways on their CT scans and have a lot of inflammatory cells in their sputum, called neutrophils. What we don't know is whether a 3 month course of the antibiotic would have as good an effect as the studies of longer courses of antibiotics and whether the effect is sustained over the course of a year. We also would like to find out whether there are any tests which can predict whether an individual is likely to have a good or poor
    E.2.2Secondary objectives of the trial
    The secondary objectives are as follows:
    - To evaluate whether any response to 3 months of erythromycin is sustained over 12 months.
    - To create phenotypes based upon inflammatory markers in blood and sputum, underlying cause and severity of the bronchiectasis, lung function and non-invasive small airway measurements while stable and during exacerbations including response to antibiotics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1 - 40 participants over 2 years including the intervention
    - Patients who have clinical symptoms suggestive of bronchiectasis confirmed by CT scan.
    - Aged 18-100.
    - Ability to give valid consent.
    - Willingness to attend the hospital every 3 months for 2 years.

    Group 2 - 50 participants for baseline visit only
    - Patients who have clinical symptoms suggestive of bronchiectasis confirmed by CT scan.
    - Aged 18-100.
    - Ability to give valid consent.
    - Willingness to attend the hospital for a one off visit.
    E.4Principal exclusion criteria
    Group 1 - 40 participants over 2 years including the intervention
    - Active TB.
    - Patients under 18 and over 100.
    - Patients who are too unwell to attend visits.
    - Patients with known cystic fibrosis.
    - Patients with traction bronchiectasis secondary to fibrosis.
    - Patients who are unable to consent.
    - Patients already on long term antibiotics.
    - Patients with macrolide allergy / severe intolerance / prolonged QT interval.
    - Patients taking medication with a known interaction with erythromycin where the use is contraindicated, with the exception of simvastatin.

    Group 2 - 50 participants for baseline visit only
    - Active TB.
    - Patients under 18 and over 100.
    - Patients who are too unwell to attend visits.
    - Patients with known cystic fibrosis.
    - Patients with traction bronchiectasis secondary to fibrosis.
    - Patients who are unable to consent.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Aim
    - We anticipate an improvement in the FEV1 of at least 200ml following a 3 month course of erythromycin at 250mg once a day.

    Primary Hypothesis
    - We hypothesize that neutrophilic airway inflammation the most common phenotype in our study population and that this group will have the best response to low dose erythromycin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study will run for 2 years for each person.
    E.5.2Secondary end point(s)
    - To evaluate whether any response to 3 months of erythromycin is sustained over 12 months.
    - To create phenotypes based upon inflammatory markers in blood and sputum, underlying cause and severity of the bronchiectasis, lung function and non-invasive small airway measurements while stable and during exacerbations including response to antibiotics.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years per person.
    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 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 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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.2.3.1Comparator description
    The first 12 months of the study prior to starting the IMP.
    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 months6
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days14
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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 completion of the study patients with difficult to control symptoms and those who are already known to the clinics will continue to be followed in the secondary setting. Patients with well controlled or mild disease will be discharged back to GP 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 Decision2014-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-12-06
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