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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-000166-35
    Sponsor's Protocol Code Number:54939
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-05-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-000166-35
    A.3Full title of the trial
    Effects of long term ToBrAmycin InhalaTion SoluTion (TIS) once daiLy on Exacerbation rate in patients with non-cystic fibrosis bronchiectasis. A double blind, randomized, placebo and TIS twice daily (open label) controlled trial. The BATTLE study.
    Effect van 1dd tobramycine verneveling op aantal exacerbaties bij patienten met non-cf bronchiectasieen. Een dubbel blind, placebo gecomtroleerde trial. en open lab tobramycine verneveling 2dd. De BATTLE studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inhaled nebulized tobramycin in non-CF bronchiectasis
    tobramycine verneveling bij non-CF bronchiectasieen
    A.4.1Sponsor's protocol code number54939
    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 SponsorNoordwest Ziekenhuisgroep
    B.1.3.4CountryNetherlands
    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 supportNoordwest Ziekenhuisgroep
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportForeest Medical School
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportPulmoscience
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNoordwest ziekenhuisgroep
    B.5.2Functional name of contact pointWG.Boersma
    B.5.3 Address:
    B.5.3.1Street Addresswilhelminalaan 12
    B.5.3.2Town/ cityAlkmaar
    B.5.3.3Post code1815JD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00317254844445464
    B.5.5Fax number0031725482167
    B.5.6E-mailw.g.boersma@nwz.nl
    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 Tobramycin Steri-Neb 300 mg/5 ml, inhalation solution
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA Pharmaceutical Industries
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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 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 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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with non-cystic fibrosis bronchiectasis
    Patienten met non-cystic fibrose bronchiectasieen
    E.1.1.1Medical condition in easily understood language
    Non-cystic fibrosis (non-CF) bronchiectasis is a chronic disorder of the airways characterized by dilation and destruction. The presence of infection and a inflammatory response are characteristic.
    Bij non-CF bronchiectasieen ontstaat verwijding en destructie van de luchtwegen, waarbij recidiverende infecties en een continue onstekingsreactie.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10070295
    E.1.2Term Infective exacerbation of bronchiectasis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine whether TIS once daily as compared to placebo may reduce the number of exacerbations in non-CF bronchiectasis and is equally effective as TIS BID open label 4 weeks on-off.
    primaire uitkomstmaat is een 50% reductie in exacerbatie rate bij het gebruik van tobramycin inhalation solution
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the effect of TIS treatment on time to next exacerbation, FVC% predicted, FEV1% predicted, LTRI-VAS, Quality of Life-Bronchiectasis (QOL-B), Leicester cough score, bacterial load in sputum and tobramycin resistance for the initial pathogens.
    secundaire uitkomstmaten zijn longfunctie, kwaliteit van leven, bacterien in sputum en tobramycine resistentie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
    3. Confirmed non-CF bronchiectasis by (HR)CT
    4. Documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within 12 months before inclusion.
    5. No course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study.
    6. Minimal one documented sputum or BAL-fluid culture with gram-negative bacteria or S.aureus (sensitive for tobramycin!!) within 12 months.
    7. Growth of protocol defined pathogens in sputum at screening visit sensitive to tobramycin
    8. Tolerance of inhaled tobramycin
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    E.4Principal exclusion criteria
    Any exacerbation within the month prior to the start of the study
    2. Diagnosis of cystic fibrosis
    3. Active allergic bronchopulmonary aspergillosis (ABPA)
    4. Any oral, IV or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study
    5. Any IV or IM corticosteroids or change in oral corticosteroids (> 10 mg) within 1 month prior to the start of the study
    6. Any change/start treatment regimens macrolides, hypertonic saline, inhaled mannitol or other mucolytics, corticosteroids within 1 month prior to the start of the study
    7. Change in physiotherapy technique or schedule within 1 month prior to the start of the study
    8. Severe immunosuppression or active malignancy
    9. Active tuberculosis
    10. Chronic renal insufficiency (eGFR < 30 ml/min)
    11. Have received an investigational drug or device within 1 month prior to the start of the study
    12. Serious or active medical or psychiatric illness
    13. Pregnancy and child bearing
    14. History of poor cooperation or non-compliance
    15. Unable to use nebulizers
    16. Allergic for tobramycin
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    E.5 End points
    E.5.1Primary end point(s)
    50% reduction in exacerbation rate in patients using TIS (OD or BID)
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    E.5.1.1Timepoint(s) of evaluation of this end point
    After informed consent patients have 3 monthly visits. During the visits patients have to deliver a sputum sample, fill in the QoL questionnaires and spirometry will be performed according the study schedule. Also a blood sample will be taken during a number of visits.
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    E.5.2Secondary end point(s)
    Secondary outcome parameters are lung function (FEV1, FVC), QoL (QOL-B), LTRI-VAS, Leicester cough score), bacterial load in sputum and tobramycin resistant pathogens.
    zie boven
    E.5.2.1Timepoint(s) of evaluation of this end point
    After informed consent patients have 3 monthly visits. During the visits patients have to deliver a sputum sample, fill in the QoL questionnaires and spirometry will be performed according the study schedule. Also a blood sample will be taken during a number of visits.
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    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 Yes
    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) 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 No
    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 trial3
    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 concerned8
    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 Yes
    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
    End of the trial when all the 78 patients are included and followed up by 13 months
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    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state78
    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)
    None
    Geen
    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 Decision2016-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-08
    P. End of Trial
    P.End of Trial StatusOngoing
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