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    Summary
    EudraCT Number:2008-001728-30
    Sponsor's Protocol Code Number:MPEX-204
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-07
    Trial results View 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 number2008-001728-30
    A.3Full title of the trial
    A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to
    Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-
    376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients
    A.4.1Sponsor's protocol code numberMPEX-204
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMpex Pharmaceuticals, 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMP-376
    D.3.2Product code MP-376
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNlevofloxacin
    D.3.9.1CAS number 100986-85-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboNebuliser 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
    Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011763
    E.1.2Term Cystic fibrosis lung
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10021860
    E.1.2Term Infection pseudomonas aeruginosa
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of three dosage regimens of MP-376 administered
    over 28 days, compared to placebo
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of three dosage regimens of MP-376
    administered over 28 days, compared to placebo

    To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) relationships for levofloxacin with MP-376 administration
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are at least 16 years of age (at least 18 years of age in Germany and the Netherlands).
    2. Have a clinical diagnosis of CF based on the following criteria:
    a) positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) and/or
    b) a genotype with two identifiable mutations consistent with CF, and
    c) accompanied by one or more clinical features consistent with the CF phenotype.
    3. Are able to elicit an FEV1 > 25% but < 85% predicted value at screening based on Hankinson/NHanes criteria (reference Hankinson, et. al).
    4. Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months and have received at least one course of inhaled tobramycin/TOBI®/colistin in the 2 months prior to Visit 1, but none in the 28 days prior to Visit 1.
    5. Must have a sputum specimen at screening positive for P. aeruginosa and have a history of at least one positive sputum culture positive for P. aeruginosa within the last 18 months.
    6. Clinically stable with no significant changes in health status within the last 30 days.
    7. Are able to perform spirometry reproducibly.
    8. Have not smoked tobacco within 30 days prior to Visit 1 and agree not to smoke for the duration of the study.
    9. Are able to reproducibly expectorate sputum.
    10. Are able to and have given written informed assent/consent in a manner approved by the Institutional Review Board/Ethics Committee and are willing to comply with the requirements of the study.
    E.4Principal exclusion criteria
    1. Have used an investigational agent within 30 days prior to Visit 1.
    2. Have used any nebulized or systemic antibiotics active against P. aeruginosa within 30 days prior to Visit 1, other than maintenance oral azithromycin, which must be have been initiated at least 30 days prior to Visit 1.
    3. History of hypersensitivity to fluoroquinolones or excipients of MP-376 (magnesium chloride).
    4. History of intolerance to bronchodilators or unwilling to use a bronchodilator during the study.
    5. Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.
    6. Changes in physiotherapy technique or schedule within 14 days prior to Visit 1.
    7. Changes in medical regimen for treatment of CF (e.g., introduction, dose escalation, or elimination of therapies such as dornase alfa, non-steroidal anti-inflammatory agents, azithromycin, hypertonic saline, or inhaled corticosteroids) within 30 days of Visit 1.
    8. History of lung transplantation
    9. Evidence of acute upper respiratory tract infection within 10 days or lower respiratory tract infection within 30 days prior to Visit 1
    10. Are pregnant, breastfeeding, or unwilling to practice birth control or abstinence during participation in the study (women only).
    11. Have a history of seizures or low seizure threshold (e.g., epilepsy).
    12. Have renal dysfunction (calculated CrCl < 50ml/min) at Screening.
    13. Have AST, ALT or total bilirubin ≥ 3 x upper limit of normal (ULN) at screening or evidence of severe liver disease (e.g., cirrhosis, portal hypertension).
    14. Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection/seropositivity. (Based on medical history, screening labs are not required.)
    15. Have a history of hemoptysis ≥ 30 mLs over any 24 hour period during the 30 days prior to Visit 1.
    16. Have an oxygen saturation < 90% on room air at Screening or Visit 1.
    17. Have a > 15% relative decline in FEV1 (L) from Screening to Visit 1.
    18. Are a dependent (as an employee or relative) of the sponsor, contract research organization or Investigator.
    19. Have a present condition, or abnormality in screening laboratory tests or physical examination findings, that in the opinion of the Investigator or Medical Monitor would compromise the safety of the patient or the quality of the data.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint
    Change in P. aeruginosa density (log10 colony-forming units [CFU] per gram
    sputum) from Visit 1 to Visit 4

    Secondary Endpoints

    Clinical
    • Changes in respiratory and other domains of CFQ-R from Visit 1 to Visit 4
    •Time to administration of IV/oral/inhaled anti-pseudomonal antimicrobials in patients with at least one of the following:
    - Decreased exercise tolerance
    - Increased cough
    - Increased sputum/chest congestion
    - Decreased appetite

    Microbiology
    • Change in P. aeruginosa density (log10 colony-forming units [CFU] per gram sputum) from Visit 1 to all subsequent scheduled study visits at which sputum for microbiology is collected (Study Visits 2, 3, 4, and Final/Early Term).
    • Changes in bacterial load of all organisms from Visit 1 to all subsequent scheduled study visits at which sputum for microbiology is collected (Study Visits 2, 3, 4 and Final Visit)
    • Changes in susceptibility patterns of isolated organisms from Visit 1 to all subsequent scheduled study visits at which sputum microbiology is collected (Study Visits 2, 3, 4 and Final Visit)

    Pulmonary Function
    • Mean percent change in FEV1, FVC, and FEF 25-75 from Visit 1 to all subsequent scheduled study visits at which PFTs are collected (Study Visits 3, 4 and Final Visit).

    Pharmacokinetic Evaluation
    • Population and Bayesian estimates of levofloxacin (e.g. AUC, Cmax, Cmin)

    Safety
    • Assessment of adverse events and drug intolerability from Visit 1 through end of study between treatment groups will be evaluated.
    • Changes from Visit 1 in physical examination findings, pulse oximetry results, pulmonary function tests, safety laboratory test results and vital signs will be evaluated.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 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.8.3 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the study is defined as the last visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-05-07. Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 190
    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)
    Since this Phase 2 study is a proof of concept trial and efficacy of MP-376 has not been established, no post study medication will be offered to trial participants.
    Patients will return to their routine 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 Decision2008-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-18
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