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    Summary
    EudraCT Number:2009-009096-35
    Sponsor's Protocol Code Number:QGUY/2008/TA-270/-01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-009096-35
    A.3Full title of the trial
    An open-label, 28-day multiple dose pilot study to evaluate the effects on lung oxidative stress, safety and pharmacokinetics of TA-270 in patients with chronic obstructive pulmonary disease (COPD).
    A.4.1Sponsor's protocol code numberQGUY/2008/TA-270/-01
    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 SponsorActivus Pharma Co., Ltd
    B.1.3.4CountryJapan
    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 name100 mg TA-270
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTA-270
    D.3.9.3Other descriptive name4-hydroxy-1-methyl-3-octyloxy-7-sinapinoylamino-2(1H)-quinolinone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Information not present in EudraCT
    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 obstructive pulmonary disease. ( COPD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects of TA-270 on predictive biomarkers of oxidative stress in
    exhaled breath condensate (EBC) such as 8-isoprostane and hydrogen peroxide
    (H2O2) and after 28 days treatment (Visit 4) as compared with baseline (Visit 2).
    E.2.2Secondary objectives of the trial
    To evaluate the effects of TA-270 on exhaled 8-isoprostane and H2O2 after 14 days treatment (Visit 3) as compared with baseline (Visit 2).
    To evaluate the effects of TA-270 on biomarkers of oxidative stress (8-isoprostane)
    and neutrophils in induced sputum after 14 (Visit 3) and 28 days treatment (Visit 4) as compared with baseline (Visit 2).
    To evaluate the effects of TA-270 on leukotrienes B4 (LTB4) in EBC and induced
    sputum after 14 (Visit 3) and 28 days treatment (Visit 4) as compared to the baseline
    (Visit 2).
    To assess the safety and tolerability of multiple oral doses of TA-270 in patients with COPD (physical tests, laboratory tests, vital signs, ECG and adverse events).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult males and females aged 40 to 75 years inclusive.
    2. Co-operative outpatients with a clinical diagnosis of COPD according to the GOLD
    Guidelines (updated 2007), and who additionally meet the following criteria:
    a) Smoking history of at least 10 pack years.
    b) Post-bronchodilator FEV1/FVC < 70% and 30% ≤ FEV1 < 80% predicted normal
    value at Visit 1 (screening). This criterion must be demonstrated after a minimum
    washout period (see exclusion criterion 18; i.e., 6 hours for inhaled short-acting
    β2-agonists (SABAs), 24 hours for long-acting β2-agonists (LABAs), 8 hours for
    short-acting anticholinergics including the fixed combinations with SABAs, 48 hours
    for long-acting anticholinergics). The post-bronchodilator FEV1 will be measured
    within 30 minutes after inhalation of SABA (salbutamol, 400 μg) and should not
    increase by more than 400 mL as compared to the pre-bronchodilator FEV1.
    3. Patients who are negative for hepatitis B surface antigen (HbsAg), hepatitis C
    antibody and human immunodeficiency virus (HIV) I and II tests at screening.
    4. Patients who are negative for drugs of abuse and alcohol tests at screening and
    admission.
    5. Patients who are able and willing to give written informed consent.
    E.4Principal exclusion criteria
    1. Patients who do not conform to the above inclusion criteria.
    2. Patients who have been hospitalized for an exacerbation of COPD in the 6 weeks
    prior to Visit 1 (screening) or the run-in period (Visit 1 – Visit 2).
    3. Patients who need long-term oxygen therapy (>16 h/day).
    4. Patients with a history of asthma suspected by (but not limited to):
    a) Blood eosinophil count 0.4 x 109/L.
    b) Onset of symptoms prior to age 40 years.
    5. Patients with concomitant pulmonary disease including lung cancer (irrespective of
    outcome), pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer
    active), bronchiectasis (congenital and acquired), diffuse panbronchiolitis, obliterative
    bronchiolitis, pneumoconiosis, interstitial lung disease, fibrosis, sarcoidosis or cystic
    fibrosis.
    6. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
    (screening). Patients who develop a respiratory tract infection during the run-in
    period (Visit 1 – Visit 2) must discontinue from the trial, but may be permitted to
    re-enroll at a later date (at least 6 weeks after the start of the respiratory tract
    infection).
    7. Patients with a history of heart failure or myocardial infarction within 3 months prior to Visit 1 (screening) or during the run-in period (Visit 1 – Visit 2).
    8. Patients with a history of significant bleeding episode or coagulation disorder within 3 months prior to Visit 1 (screening) or during the run-in period (Visit 1 – Visit 2).
    9. Patients with a known history of chronic alcoholics or drug abuse.
    10. Patients who, in the judgment of the Investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertention, type-I or uncontrolled type-II diabetes, or any condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
    11. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases).
    Localized basal cell carcinoma (without metastases) of the skin is acceptable.
    12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of female after conception and until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hCG) laboratory test.
    13. Male and female patients who do not agree to use two effective methods of
    contraception (as defined in Section 7.2.3.2) for the duration of the study and for
    3 months after the final dose of TA-270.
    14. Patients with a history of clinically significant dug allergy to any of drugs with similar chemical structure to TA-270 or any components of the study drug.
    15. Patients who have had treatment with other investigational drugs at the time of
    enrollment, or within 3 months or 5 half-lives prior to Visit 1 (screening), whichever
    is longer.
    16. Patients who have had live attenuated vaccinations within 30 days prior to Visit 1
    (screening) or during the run-in period (Visit 1 – Visit 2). Inactivated influenza
    vaccination, pneumococcal vaccination or any other inactivated vaccine is acceptable
    provided it is not administered within 48 h prior to Visits 1 or 2.
    17. Patients who have had treatment with the following medications within a specified period prior to Visit 1. These medications must not be used during the study:
    • Corticosteroids (oral, inhaled, intravenous or intramuscular) within 4 weeks.
    • Fixed combinations of inhaled corticosteroids and β2- adrenergic receptor
    agonists within 4 weeks.
    • 5-LO inhibitors (e.g. zileuton) within 2 weeks.
    • Leukotriene antagonists (e.g. pranlukast, zafirlukast, montelukast) within
    2 weeks.
    • Xanthine derivatives within 2 weeks.
    • Acetylcysteine and Carbocysteine within 4 weeks
    18. Patients who have had treatment with the following bronchodilators within a specified period prior to Visit 1. These medications are allowed to use during the study, but should be withheld in the following period before spirometry at Visits 2 (Day 1), 3(Day 15) and 4 (Day 29):
    • SABAs: 6 h.
    • LABAs: 24 h.
    • Short-acting anti-cholinergics: 8 h.
    • Fixed combinations of SABAs and short-acting anticholinergics (e.g.,
    Combivent®): 8 h.
    • The long-acting anti-cholinergic agent (tiotropium): 48 h.
    19. Patients who have previously received TA-270.
    20. Patients who cannot communicate reliably with the Investigator or are unlikely to
    co-operate with the requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the effects of TA-270 on predictive biomarkers of oxidative stress in
    exhaled breath condensate (EBC) such as 8-isoprostane and hydrogen peroxide
    (H2O2) and after 28 days treatment (Visit 4) as compared with baseline (Visit 2).
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 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 Information not present in EudraCT
    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
    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 months9
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12
    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 Decision2009-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-16
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