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    Summary
    EudraCT Number:2008-002230-30
    Sponsor's Protocol Code Number:D4260C00003
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-25
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-002230-30
    A.3Full title of the trial
    A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236 as an Oral Tablet in Patients with Moderate to Severe COPD.
    A.4.1Sponsor's protocol code numberD4260C00003
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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.3.2Product code AZD1236
    D.3.4Pharmaceutical form 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 codeAZD1236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    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 (study conducted in men or women, not of child bearing potential, aged 40 years or above).
    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 investigate the tolerability and safety of AZD1236, as an oral tablet, in COPD patients by assessment of:
    incidence and nature of adverse events
    vital signs and laboratory safety assessments
    E.2.2Secondary objectives of the trial
    To assess the effects of AZD1236 compared with placebo on lung function, COPD symptoms, functional capacity, the BODE index, selected biomarkers in urine and blood and systemic exposure of AZD1236.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Men, or postmenopausal/hysterectomised/oophorectomised women ≥ 40 years of
    age. Postmenopausal women defined as being amenorrhoeic for at least 24 months.
    3. A minimum weight of 50 kg
    4. Diagnosis of COPD for at least 1 month
    5. FEV1 30 to 80 % of the predicted normal value (post-bronchodilator) and
    post-bronchodilator FEV1/FVC < 70 %
    6. Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack
    year = 20 cigarettes smoked per day for one year. For cigars, cigarillos etc see
    further information in eCRF instructions)
    7. Patients that are able to discontinue non-allowed concomitant medication
    8. Recent or current use of short-acting rescue/reliever medication.
    For inclusion in the study at Visit 3 the patients must fulfil the following criterion:
    1. A score ≥ 1 on Breathlessness score on at least half of the numbers of days during
    the run-in period. (At least 6 days with a score ≥ 1 on Breathlessness score are
    needed).
    E.4Principal exclusion criteria
    1. Any clinically relevant disease or disorder (past or present), which, in the opinion
    of the investigator, may either put the patient at risk because of participation in
    the study, or influence the results of the study, or the patient’s ability to participate
    in the study
    2. Any current respiratory tract disorder other than COPD, which is considered by
    the investigator to be clinically significant or may influence the result of the study
    3. A clinical suspicion of active or latent tuberculosis defined as any of the following:
    a) positive tuberculosis test (such as Quantiferon-GOLD or Mantoux-test
    (>5 mmin unvaccinated individuals and >10 mm in individuals with previous
    BCG-vaccination),
    and/or
    b) suspicion of active or latent tuberculosis on chest X-ray taken within last 12
    months.
    and/or
    c) past medical history of tuberculosis
    4. Malignancy or neoplastic disease within the last 5 years, other than treated
    basal/squamous cell skin cancer or treated cervical cancer in situ
    5. Disease history suggesting reduced or abnormal immune function
    6. Any clinically relevant abnormal findings in physical examination, clinical
    chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in
    the opinion of the investigator, may put the patient at risk because of his/her
    participation in the study
    7. Patients with glomerular filtration rate less than 60 mL/min, calculated as creatinine clearance from serum-creatinine according to the Cockcroft and Gault formula: (CLcreatinine (mL/min)=constant x (140-age) x weight (kg)/serum creatinine (µM). Constant being 1.23 for men and 1.04 for women.
    8. Known HIV infection, or patients who belong to a high risk group for HIV
    9. Increased Cardiac Troponin I>Upper Limit of Normal (ULN) at Visit 2
    10. Patients with underlying musculoskeletal symptoms of unknown origin and
    patients with shoulder girdle musculoskeletal symptoms or Dupuytrens contracture
    symptoms as judged by the Investigator
    11. Requirement for regular oxygen therapy
    12. An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or oral
    or parenteral glucocorticosteroids (GCS) and/or hospitalization related to COPD)
    within 30 days of Visit 2, or during the run-in period
    13. Use of oral or parenteral glucocorticosteroids within 30 days prior to Visit 2, or
    during the run-in period
    14. Known or suspected hypersensitivity to study therapy or excipients of the
    investigational product
    15. History of, or, current alcohol or drug abuse, as judged by the investigator
    16. Scheduled in-patient hospitalization during the course of the study
    17. Donation of blood within 3 months prior to Visit 2
    18. Vaccination within 2 weeks prior to Visit 2
    19. Previous randomisation of treatment in the present study
    20. Participation in another clinical study involving drug administration during the last
    3 months before Visit 2
    21. Involvement in the planning and/or conduct of the study (applies to both
    AstraZeneca staff and/or staff at the study site)
    22. Clinical judgement by the investigator that the patient should not participate in
    the study
    If the patient participates in the genetic part of the study these exclusion criteria apply as well:
    23. Whole blood transfusion within 120 days of the date of genetic sample collection
    24. Previous bone marrow transplant
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    Adverse events, blood pressure, pulse, electrocardiogram and laboratory
    safety variables (clinical chemistry, haematology, urinalysis).
    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 No
    E.6.10Pharmacogenetic Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    The end of the entire study is defined as database lock, since the analysis of biomarkers will take at least 6 weeks after the last visit of the last patient 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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2008-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-21
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