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    Summary
    EudraCT Number:2021-002335-33
    Sponsor's Protocol Code Number:KKS-287
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-002335-33
    A.3Full title of the trial
    Inhaled ColiFin® in adult bronchiectasis patients with early asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial
    Inhaliertes ColiFin® in erwachsenen Bronchiektasie Patienten mit früher asymtomatischer Pseudomonas aeruginosa Infektion- eine unverblindete, randomisierte Proof of Concept IIT Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inhalation therapy in adult bronchiectasis patients with early asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial
    Inhalationstherapie bei erwachsenen Bronchiektase-Patienten mit früher asymptomatischer Pseudomonas aeruginosa-Infektion - eine offene, randomisierte Proof of Concept IIT Studie
    A.3.2Name or abbreviated title of the trial where available
    ERADICATE
    A.4.1Sponsor's protocol code numberKKS-287
    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 SponsorPhilipps University Marburg
    B.1.3.4CountryGermany
    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 supportGerman Center for Lung Research (DZL)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportPARI GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKoordinierungszentrum für Klinische Studien (KKS) Marburg
    B.5.2Functional name of contact pointKKS Marburg
    B.5.3 Address:
    B.5.3.1Street AddressKarl-von-Frisch-Straße 4
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35043
    B.5.3.4CountryGermany
    B.5.6E-mailkirsten.murmann@kks.uni-marburg.de
    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 ColiFin(R)
    D.2.1.1.2Name of the Marketing Authorisation holderPARI Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameColiFin
    D.3.2Product code J01X B01
    D.3.4Pharmaceutical form Powder for nebuliser solution
    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 INNCOLISTIMETHATE SODIUM
    D.3.9.1CAS number 8068-28-8
    D.3.9.4EV Substance CodeSUB06801MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000000
    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
    bronchiectasis
    E.1.1.1Medical condition in easily understood language
    permanent enlargement of parts of the airways of the lung (bronchiectasis), with inflammatory processes
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of ColiFin® therapy for 4 weeks compared to no therapy on sputum/airway culture negativity for PA 28 weeks after randomisation
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of ColiFin® therapy for 4 weeks compared to no treatment on
    change in PA bacterial density (colony forming units; CFUs) in sputum from baseline to Day 29 of treatment
    the frequency of (mild to moderate) pulmonary exacerbations (requiring antibiotic treatment) in 28 weeks after Randomisation
    the frequency of severe exacerbations (hospitalizations) in 28 weeks after Randomisation
    time to first pulmonary exacerbation (requiring antibiotic treatment) after start of treatment
    quality of life (QoL) measured by the St. George’s Respiatory Quenstionnaire (SGRQ)
    Respiratory Symptom Score (RSS) measured by the Quality of Life Questionnaire Bronchiectasis (QoL-B)
    overall QoL measured by the Quality of Life Questionnaire Bronchiectasis (QoL-B)
    • To evaluate the effect of ColiFin® therapy for 4 weeks compared to no treatment on change in ppFEV1
    • To evaluate the change in antibiotic susceptibility in sputum bacteria over the 24 weeks follow up period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years
    • Bronchiectasis verified by chest CT scan.
    • New positive sputum culture for PA.
    • At least one negative sputum culture for PA in the last 6 months and at least two negative sputum cultures for PA in the last 12 months*
    • No recent onset of new respiratory symptoms or worsening of pre-existing respiratory symptoms (e.g. cough, sputum amount, sputum colour, sputum viscosity, haemoptysis, decreased exercise capacity, malaise, fatigue etc.) over the last 2 months, as per investigator judgement.
    • Written informed consent
    • Negative serum/urine pregnancy test in women of childbearing potential (WOBCP)
    • Women with reproductive potential must agree to maintain highly effective methods of contraception during study treatment and at least 12 weeks thereafter by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used
    • Male subjects should use condom during treatment and until the end of relevant systemic exposure in the male subject, plus a further 90-day period.
    For a non-pregnant WOCBP partner, contraception recommendations should also be considered.

    *Cultures obtained while clinically stable and not on antipseudomonal treatment.
    E.4Principal exclusion criteria
    • Bronchiectasis due to cystic fibrosis
    • Known prior infection with PA in the past 5 years
    • Treatment with inhaled antibiotics
    • Known intolerance to ColiFin® in prior medical history
    • Hypersensitivity/Known intolerance to Colistimethate sodium, Colistin, polymyxin B or to other polymyxins
    • Known diagnosis of myasthenia gravis or porphyria
    • ppFEV1 < 30%
    • breast feeding
    • strongly impaired renal function, GFR ≤ 30 ml/min
    • Participation in any other interventional clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of sputum/airway culture negativity (=3 consecutively negative sputum/airway cultures) for PA 28 weeks after randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 weeks after randomisation
    E.5.2Secondary end point(s)
    • Change in PA colony forming units (CFUs) in sputum from baseline to Day 29 of treatment
    • Rate of pulmonary exacerbations in 28 weeks after randomisation
    • Rate of severe exacerbations (hospitalizations) in 28 weeks after randomisation
    • Time to first pulmonary exacerbation after start of treatment
    • Change from baseline in respiratory symptom domain of the SGRQ over the 24 weeks follow up period
    • Change from baseline in quality of life measured by SGRQ over the 24 weeks follow up period
    • Change from baseline in quality of life measured by QOL-B over the 24 weeks follow up period
    • Change from baseline on change in ppFEV1 over the 24 weeks follow up period
    • Change in antibiotic susceptibility in isolated sputum PA over the 24 weeks follow up period
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 weeks after randomisation
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    comparison to control group (standard of care)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 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 + database closure
    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 months7
    E.8.9.1In the Member State concerned days0
    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: 66
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state66
    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)
    Best medical care according to guidelines will be given to all patients.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-18
    P. End of Trial
    P.End of Trial StatusOngoing
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