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    Summary
    EudraCT Number:2015-003399-58
    Sponsor's Protocol Code Number:COPTRIN1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-01-07
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-003399-58
    A.3Full title of the trial
    Target-ABC (Targeted AntiBiotics for Chronic pulmonary disease):
    Can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma?
    Target-ABC (Targetted AntiBiotics for COPD):
    Kan målrettet antibiotikabehandling forbedre prognosen hos KOL-patienter med KOL, non-cystisk fibrose bronkiektasier og astma der er inficerede med Pseudomonas aeruginosa?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma?
    Kan antibiotikabehandling forbedre prognosen ved Pseudomonas aeruginosa infektion hos patienter med KOL, non-cystisk fibrose bronkiektasier og astma?
    A.3.2Name or abbreviated title of the trial where available
    Target-ABC (Targetted AntiBiotics for Chronic pulmonary disease)
    A.4.1Sponsor's protocol code numberCOPTRIN1
    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 SponsorCOP:TRIN Region Hovedstaden (Gentofte hospital)
    B.1.3.4CountryDenmark
    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 supportCOP:TRIN Region Hovedstaden
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCOP:TRIN Region Hovedstaden
    B.5.2Functional name of contact pointGentofte Hosptial
    B.5.3 Address:
    B.5.3.1Street AddressKildegårdsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number004539773977
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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.2.5The 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 nameCiprofloxacin
    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 INN ciprofloxacin hydrochloride
    D.3.9.1CAS number 86393-32-0
    D.3.9.3Other descriptive nameCIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB25858
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 2
    D.1.2 and D.1.3IMP Role
    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.2.5The 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 namePiperacillin/Tazobactam
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpiperacillin sodium , tazobactam sodium
    D.3.9.3Other descriptive namePIPERACILLIN SODIUM
    D.3.9.4EV Substance CodeSUB03840MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4000/500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory tract infection
    Bacterial infection with Pseudomonas aeruginosa
    Chronic obstructive pulmonary disease (COPD)
    Non-cystic fibrosis bronchiectasis
    Asthma
    Luftvejsinfektion
    Bakteriel infektion med Pseudomonas aeruginosa
    Kronisk obstruktiv lungesygdom (KOL)
    Non-cystic fibrose bronkiektasier
    Astma
    E.1.1.1Medical condition in easily understood language
    Respiratory tract infection in patients with chronic respiratory disease.
    Luftvejsinfektion hos patienter med kronisk lungesygdom.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021860
    E.1.2Term Infection Pseudomonas aeruginosa
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main purpose of the trial is to investigate if targetted antibiotics against respiratory tract infection with Pseudomonas aeruginosa can improve the prognosis in patients with COPD, non-CF bronchiectasis and asthma.

    Patients will be allocated to the following 2 study arms:
    1) no antibiotic treatment
    2) intravenous tazocin 4/0.5 g four times daily + tablet ciprofloxacin 500 mg twice daily for 14 days
    Hovedformålet er at undersøge om antibiotikabehandling af luftvejsinfektions med Pseudomonas aeruginosa kan forbedre prognosen hos patienter med KOL, non-cystic fibrose bronkiektasier og astma .

    Patienter allokeres til en af følgende 2 studiearme:
    1) Ingen antibiotisk behandling
    2) Intravenøs Tazocin 4 g x 4 daglig + Tablet Ciprofloxacin 500 mg x 2 daglig i 14 dage
    E.2.2Secondary objectives of the trial
    A) To investigate if infection with Pseudomonas aeruginosa is an independent predictor for exacerbation and mortality i patients with COPD
    (nationwide database study).

    B) To investigate if Pseudomonas aeruginosa causes chronic colonisation or rather episodic infections in the respiratory tract in patients with COPD
    (genetic study: prospective pilot study of the randomized study).
    A) At undersøge om tilstedeværelse af PA i luftvejene er en uafhængig prædiktor for risikoen for KOL eksacerbation og død i en landsdækkende database-undersøgelse af patienter med KOL.

    B) At afklare om samme PA-stamme koloniserer luftvejene igennem måneder til år ved svær KOL eller om PA forårsager gentagne klonisk adskilte episoder af kolonisation/infektion (genetisk studie, foretages prospektivt i en pilotfase af det randomiserede studie).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Please see E 2.2 (A+B).
    No titles at the time.
    Both will be conducted in the same period as the randomized study.
    Se venligst E 2.2 (A+B).
    Ikke navngivne endnu.
    Vil udføres i samme periode som det randomiserede studie.
    E.3Principal inclusion criteria
    - Lower respiratory sample with Pseudomonas aeruginosa
    - COPD, non-CF bronchiectasis or asthma
    - History of minimum 2 exacerbations or 1 hospital/emergency department-requiring exacerbation with administration of systemic prednisolone and/or antibiotic treatment within the last 12 months
    - Pseudomonas aeruginosa i nedre luftvejsprøve
    - KOL, non-CF bronkiektasier og astma
    - Minimum 2 tidligere ekacerbationer eller 1 tidligere indlæggelses- eller skadestuekrævende eksacerbation med behov for systemisk prednisolon og7eller antibiotika indenfor de sidste 12 måneder
    E.4Principal exclusion criteria
    - Immune modulating therapy
    - Male < 40 years
    - Female < 55 years
    - Non-menopausal female > 55 years
    - Expected lifetime < 90 days
    - Severe psychiatric disease
    - Severe language problems
    - Known allergy against fluorquinolon and both penicillin/piperacillin, cefalosporin and carbapenem
    - Received eradication therapy against PA twice within the last 12 months or full completion of eradication therapy against PA within the last 14 days
    - Investigator thinks that trial participant should receive antibiotics for PA under all circumstances. This exclusion criterion must be discussed with the coordinating investigator before the final decision is taken
    - Immunmodulerende behandling
    - Mand < 40 år
    - Kvinder < 55 år
    - Ikke-menopausale kvinder > 55 år
    - Forventet levetid < 90 dage
    - Svær psykisk sygdom
    - Svære sproglige problemer
    - Kendt lægemiddelsallergi overfor fluorquinolon og både penicillin/piperacillin, cefalosporin og carbapenemer
    - Forsøgt eradikationskur mod PA x 2 de sidste 12 måneder eller afsluttet en komplet sådan indenfor 14 dage
    - Investigator vurderer at forsøgsdeltaget under alle omstændigheder skal have antibiotika. Dette eksklusionskriterie skal diskuteres med koordinerende investigator inden endelig beslutning om eksklusion træffes
    E.5 End points
    E.5.1Primary end point(s)
    - Time to prednisolone and/or antibiotic requiring exacerbation or death, in primary or secondary health care sector from day 20 to day 365 from randomization.
    - Days alive and without exacerbation from day 20 to day 365 from randomization.
    - Tid til prednisolon- og/eller antibiotikakrævende KOL, non-CF bronkiektasier eller astma -eksacerbation eller død, i både primær samt sekundær sektor mellem dag 20-365 fra inklusion. Tidsramme for dette: Afgøres af hvornår 2/3 (67%) af individerne i den antibiotika-frie gruppen har fået en KOL-eksacerbation, forventet ca. 12 måneder
    - Dage i live og uden KOL, non-CF bronkiektasier eller astma-eksacerbation mellem dag 20-365 fra inklusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluated when 2/3 (67%) of the patients in the mono therapy group have had an exacerbation, expected within 12 months.
    Afgøres af hvornår 2/3 (67%) af monoterapi-gruppen har fået en KOL-eksacerbation, forventet inden for 12 måneder.
    E.5.2Secondary end point(s)
    - Death within 12 months
    - Number of COPD exacerbations within 12 months
    - Number of days with non-invasiv-ventilation (NIV) or intubation within 90 days from inclusion
    - Change in FEV1 from baseline to 3 months
    - Fall in FEV1 from baseline ≥ 200 ml at day 365
    - Change in COPD Assessment Test (CAT) from baseline to 3 months
    - Change in body mass index (BMI) from baseline to 3 months
    - Microbiological cure
    - Clinical cure
    - For patients with COPD: days alive and out of hospital within day 20-365 from randomization
    - Død indenfor 12 måneder
    - Antal genindlæggelser med KOL-eksacerbation indenfor 12 måneder.
    - Antal dage med non-invasiv-ventilation (NIV) eller respiratorbehandling indenfor 90 dage efter inklusion
    - Ændring i FEV1 fra baseline til 3 måneder
    - Fald af FEV1 fra baseline på ≥ 200 ml på dag 365
    - Ændring i COPD Assessment Test (CAT) fra baseline til 3 måneder
    - Ændring i body mass index (BMI) fra baseline til 3 måneder
    - I live og uden KOL-eksacerbation på dag 365
    - Mikrobiologisk helbredelse
    - Klinisk helbredelse
    - KOL-patienter: antal indlæggelsesfrie dage i live indenfor dag 20-365 fra inklusion
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluated when 2/3 (67%) of the patients in the mono therapy group have had an exacerbation, expected within 12 months.
    Afgøres af hvornår 2/3 (67%) af monoterapi-gruppen har fået en KOL-eksacerbation, forventet inden for 12 måneder.
    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 Yes
    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
    Ingen behandling
    No treatment
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    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
    Trial ends when 2/3 (67%) of the enrolled patients in the monotherapy group have had an exacerbation, expected within 12 months.

    Last follow-up planned after 365 days.
    Afgøres af hvornår 2/3 (67%) af de inkluderede patienter i monoterapi-gruppen har fået en KOL-eksacerbation, forventet indenfor 12 måneder.

    Sidste planlagte opfølgning er efter 365 dage.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state150
    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)
    Not different from the expected normal treatment.
    Ikke anderledes end forventet normal behandling.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation COP:TRIN
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-01
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