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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7264   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:2022-000476-18
    Sponsor's Protocol Code Number:SPX-CF-001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-31
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2022-000476-18
    A.3Full title of the trial
    Tolerability and Safety of Inhaled Colistimethate Sodium Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT)
    A naponta egyszer alkalmazott inhalációs kolisztimetát-nátrium tolerálhatósága és biztonságossága a napi kétszeri adagolással összehasonlítva cisztás fibrózisban és krónikus Pseudomonas aeruginosa tüdőfertőzésben (COPILOT) szenvedő felnőtt és serdülőkorú vizsgálati alanyoknál
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test how well inhalation of Colistimethate Sodium once a day is tolerated and how safe it is compared with inhalation of Colistimethate Sodium two times a day in adult and children with Cystic Fibrosis and lung infection (COPILOT)
    Ez a vizsgálat annak tesztelésére szolgál, hogy a kolisztimetát-nátrium napi egyszeri belélegzése mennyire tolerálható, és mennyire biztonságos a kolisztimetát-nátrium napi kétszeri belélegzéséhez képest cisztás fibrózisban és tüdőfertőzésben szenvedő felnőtteknél és gyermekeknél (COPILOT)
    A.3.2Name or abbreviated title of the trial where available
    COPILOT
    A.4.1Sponsor's protocol code numberSPX-CF-001
    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 SponsorEnBiotix, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEnBiotix, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccelsiors CRO and Consultancy Services Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address103 Haros Str.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1222
    B.5.3.4CountryHungary
    B.5.4Telephone number003612990091
    B.5.5Fax number00381216503380
    B.5.6E-mailregulatory@accelsiors.com
    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 Colfinair 2 MIU Powder for Nebuliser Solution
    D.2.1.1.2Name of the Marketing Authorisation holderPARI Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameColistimethate sodium (CMS)
    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 million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis
    E.1.1.1Medical condition in easily understood language
    Chronic lung infections caused by specific bacteria called Pseudomonas aeruginosa in patients with cystic fibrosis.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011763
    E.1.2Term Cystic fibrosis lung
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tolerability and Safety of Open Label inhaled colistimethate sodium, comparing once daily (QD) with twice daily (BID) Administration for 28 days, measured by safety and respiratory tolerability events.
    E.2.2Secondary objectives of the trial
    Additional assessments of pulmonary function and clinical events as measured by
    • Pulmonary function (ppFEV1)
    • Pulmonary exacerbations (PEx), severity of PEx, hospitalizations
    • Additional antibacterials taken
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects, ages 12 years and older:
    a. Step A: ages 18 years and older
    b. Step B: ages 12 years and older
    2. Previous diagnosis of cystic fibrosis as confirmed by:
    a. documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test prior to initiation of therapy with CFTR modulators (e.g., elexacaftor, tezacaftor, ivacaftor), if applicable; or
    b. two well-characterized genetic mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene; and
    c. symptoms characteristic of cystic fibrosis
    3. Persistent airways infection with P. aeruginosa as evidenced by:
    a. positive P. aeruginosa in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening; or
    b. history of inhaled antibiotic treatment for suppression of P. aeruginosa
    4. Stable treatment regimen of CF therapeutics for at least 2 months prior to randomization
    defined as:
    a. regimen of inhaled antibacterials for either at least 2 months of continuous therapy or at least a total of 56 days of consecutive on treatment periods in case of cyclical therapy (e.g. 28 day on treatment, followed by 28 days off treatment, followed by another 28 days on treatment) prior to randomization AND
    b. no changes in either any current treatment regimen or initiation of treatment with hypertonic saline, dornase alfa, CFTR modulators or other CF specific therapeutics.
    5. FEV1 at screening of ≥30% of predicted values
    6. Arterial oxygen saturation (SpO2) ≥ 90% on room air at screening
    E.4Principal exclusion criteria
    1. Hx of daily continuous O2 or requirement for > 2 liters/min at night
    2. Hx of any investigational drug/device use within 28 days of screening or within 6 half-lives of investigational drug (whichever is longer)
    3. Hx of lung or liver transplantation
    4. Hx or current diagnosis of myasthenia gravis or porphyria
    5. Abnormal renal or hepatic function measured in serum chemistry at screening (AST or ALT > 3x upper limit of normal (ULN); Creatinine > 2x ULN)
    6. Positive pregnancy test at screening
    E.5 End points
    E.5.1Primary end point(s)
    Number of observed safety events during the 28-day treatment period in each treatment arm
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    1. Number of observed safety events during the 42-day follow-up period in each treatment arm
    2. Number of observed safety events during the 169 days total follow-up period in each treatment arm
    3. Absolute change from baseline (Day 1) to Day 14 and Day 28 in ppFEV1 in each treatment arm
    4. Change in mean absolute ppFEV1 from baseline (after SABA) to post dose values during
    serial spirometry at Day 1 and Day 28 in each treatment arm
    5. Number of newly diagnosed total and severe PEx from baseline (Day 1) to Day 28, to Day 42 and to 169 in each treatment arm
    6. Additional antibacterials taken
    7. Number of hospitalizations from baseline (Day 1) to Day 28, to Day 42 and to Day 169 in each
    treatment arm
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 42 days
    2. 169 days
    3. Day 14 and Day 28
    4. Day 1 and Day 28
    5. Day 28, Day 42 and Day 169
    6. Day 28
    7. Day 28, Day 42 and Day 169
    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 Yes
    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) 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 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
    different dose of the same medicinal product
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Greece
    Hungary
    Poland
    Slovakia
    United Kingdom
    Bulgaria
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    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 months8
    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 Yes
    F.1.1Number of subjects for this age range: 18
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    children aged 12-17 years
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 38
    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 end of the study the patient will return to standard treatment.
    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 Decision2022-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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