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    Summary
    EudraCT Number:2011-000192-13
    Sponsor's Protocol Code Number:COLO/DPI/02/11
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-31
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-000192-13
    A.3Full title of the trial
    A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosis
    A.3.2Name or abbreviated title of the trial where available
    Colistin Systemic Exposure (COSY) study
    A.4.1Sponsor's protocol code numberCOLO/DPI/02/11
    A.5.4Other Identifiers
    Name:Chemical Abstract Service (CAS)Number:8068-28-8
    Name:BAN, USANNumber:Colistimethate sodium
    Name:Other Descriptive nameNumber:Colistimethatum natricum
    Name:Other Descriptive nameNumber:Colistin sodium methanesulfonate
    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 SponsorForest Laboratories UK Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportForest Laboratories UK Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials
    B.5.2Functional name of contact pointMahwish Moghul
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, 172 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 7NS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44207121 6178
    B.5.5Fax number44207121 6160
    B.5.6E-mailmahwish.moghul@wwctrials.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/02/088
    D.3 Description of the IMP
    D.3.1Product nameColobreathe
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 8068288
    D.3.9.3Other descriptive nameColistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number125
    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 Yes
    D.3.11.13.1Other medicinal product typeColobreathe®, a hard capsule containing 125mg of colistimethate sodium for inhalation using the Turbospin® device.
    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
    systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
    E.1.1.1Medical condition in easily understood language
    chronic bacterial lung infection in cystic fibrosis patients
    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 13.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    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
    To assess the magnitude of systemic exposure to colistimethate after repeat dosing with Colobreathe® in adult, adolescent and paediatric subjects with cystic fibrosis.
    E.2.2Secondary objectives of the trial
    • To establish the full PK profile of the drug substance
    • To monitor the safety of Colobreathe® after 7 days repeat dosing
    • To compare microbiological and LC/MS/MS assays for the detection of colistin/colistimethate
    • To estimate treatment compliance
    • To assess changes in FEV1 % predicted
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subjects aged 6-60 years.
    • Subjects must have a documented diagnosis of Cystic Fibrosis from a specialist CF Unit (genotype and/ or positive sweat tests).
    • If the subject is female and post-menarche/ pre-menopausal and heterosexually active, the patient must be using adequate effective contraceptive methods.
    • Subjects will have documented microbiological evidence of “chronic pulmonary infection” with PA infection (including colonisation), defined as either:
    (i) ≥ 50% samples (minimum of 3 samples: sputum samples or throat swabs) positive for PA over the previous 12 months prior to the first day of trial medication administration (Visit 1) OR
    (ii) two samples (sputum samples or throat swabs) positive for PA over the previous 6 months prior to the first day of trial medication administration (Visit 1).
    • Subjects are required to be non-smokers or a past smoker who has not smoked within the past 12 months prior to the first day of trial medication administration (Visit 1).
    • Each subject or parent/guardian must be capable of reading and understanding informed consent and the trial information leaflet (or simplified assent document for those under the legal contractual age of consent and able to
    read) and understand and must have granted his or her written informed consent (or assent as appropriate) before any trial procedure is carried out.
    • Current CF condition must be clinically stable in the investigator’s opinion i.e. there must be no evidence of a current acute respiratory exacerbation within 7 days prior to the first day of trial medication administration (Visit
    1).
    • Subjects with an FEV1 predicted, greater than 25%. Lung function anticipated in the opinion of the investigator to be clinically stable for the duration of the study.
    • Subjects should continue with all pre-existing medications unless specified in the protocol exclusion criteria (4.2). Changes are to be recorded in the CRF with reasons.
    E.4Principal exclusion criteria
    • Evidence of an acute respiratory exacerbation within 7 days prior to the first day of trial medication
    administration (Visit 1). The protocol definition of an acute respiratory exacerbation is the presence of at least
    four of the following:
    (i) Change in appearance of sputum (i.e. increased purulence or volume).
    (ii) Increased productive cough, dyspnoea or respiratory rate.
    (iii) Progressive physical findings (crackles, rhonchi and air exchange) on chest auscultation.
    (iv) New (infiltrates) intrusion on chest X-ray.
    (v) Lassitude and decreased exercise tolerance.
    (vi) Fever (≥38oC).
    (vii) Deterioration of 10% of highest FEV1 score obtained in the last 6 months.
    (viii) Decreased appetite.
    (ix) Emergence of new pathogen in sputum i.e. a pathogen that causes clinical disease.
    If a subject has less than four of the above and receives a course of intravenous antibiotics, or if there is an
    unscheduled course without clear evidence of an acute pulmonary infective exacerbation, then this is considered
    an acute exacerbation and an exclusion criterion.
    • Known allergy/hypersensitivity (or previous intolerance) to colistimethate sodium, or any inhaled dry powder
    pharmaceutical.
    • Administration of any investigational product within 28 days prior to first trial medication administration (Visit
    1).
    • Subjects who have received treatment that has permanently reduced PA infection status will not be included
    (e.g. effective anti-pseudomonal vaccination and gene therapy).
    • Subjects who are or will be receiving a planned/scheduled course of elective iv antibiotic therapy during the
    course of the study.
    • Subjects who have received iv colistin in previous 28 days.
    • Subjects receiving inhaled antibiotics (Colistin, colistimethate, TOBI, aztreonam, ciprofloxacin, levofloxacin or
    other aminoglycoside in the previous 72hrs prior to study drug administration. All subjects will be washed out
    from inhaled antibiotic medication for 3 days prior to study entry.
    • Subjects who are infected with Burkholderia or have active allergic bronchopulmonary aspergillosis (ABPA).
    • Existence of any pre-study medical conditions which, in the judgement of the investigator, warrant exclusion
    from the study. Pre existing renal impairment is not an exclusion criterion.
    • Subjects who are pregnant or breast-feeding, or who plan to become pregnant during the study period.
    • Inability to communicate or cooperate with the investigator due to language problems, poor mental development
    or impaired cerebral function.
    • Inability to comply with any of the study procedures or the study regimen (including inability to use
    Colobreathe® inhaler i.e. Turbospin® device for duration of the trial).
    • Screening laboratory parameters falling outside the expected normal ranges for CF (investigator decision).
    • Evidence of significant hepatic impairment (investigator decision)
    • Subjects who in the opinion of the investigator are unsuitable for any reason to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the PK profile of the drug substance colistimethate, colistin A and colistin B in plasma, and urine, including plasma Cmax and Tmax in paediatric, adolescent and adult subjects. Also sputum samples will be collated to confirm that drug has been inhaled during administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PK timepoints are predose and post dose (15min, 30min, 1hr, 2hr, 3hr and 6 hrs post dose) for blood samples.
    PK timepoints are predose and post dose (0-6 hrs, and 6 hrs post dose) for urine samples.
    PK timepoints are predose and 1hr-post-dose for sputum samples
    E.5.2Secondary end point(s)
    • Frequency and severity of AEs
    • Clinically significant changes in laboratory values
    • Changes in FEV1 % predicted
    • Differences between microbiological and LC-MS/MS assay results used to establish systemic exposure of colistin and colistimethate
    • Subjects’ compliance on study medication
    • “As needed” use of bronchodilators
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 & day pre-post dose8 assessments
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pharmacokinetics study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Ukraine
    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
    last visit of the last subject undergoing the trial
    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 months6
    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 months6
    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: 16
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    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 6-17 years
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 28
    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 study the subject will resume the treatment to what they were receiving prior to joining the study.
    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 Decision2011-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-23
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