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    Summary
    EudraCT Number:2005-004110-32
    Sponsor's Protocol Code Number:D1521C00002
    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:2005-12-08
    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 number2005-004110-32
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase II Study to Assess The Efficacy of AZD9056 (single oral 400 mg dose) when Administered for 4 Weeks in Patients with Moderate to Severe COPD
    A.4.1Sponsor's protocol code numberD1521C00002
    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 Information not present in EudraCT
    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 nameAZD9056
    D.3.2Product code AZD9056
    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.3.11 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine the efficacy of AZD9056 (single oral 400 mg dose) in moderate to severe COPD patients during a 4-week treatment period.
    E.2.2Secondary objectives of the trial
    1. To determine the safety and tolerability (recording of AEs, safety laboratory data and ECGs) of AZD9056 in COPD patients
    2. To determine the PK of AZD9056 in patients with moderate to severe COPD by measurement of pre-dose (trough) and post-dose plasma concentrations and estimation of clearance (CL/F) and volume of distribution (Vss/F).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent (prior to any study-related procedures or restrictions)
    2. Male or female aged between 40 to 80 years
    3. Females must be using 2 forms of contraception (eg, oral contraception and barrier method) for the duration of the study, unless they are surgically sterile or post?menopausal
    4. Clinical diagnosis of COPD (documented in patient notes) for more than 2 years
    5. Patients must not be at risk of active tuberculosis including disease reactivation as indicated by a negative result in all of the following:
    (i) Past medical history of TB or current symptoms suggestive of active TB
    (ii) A positive tuberculin (Mantoux) test in response to intradermally dosed tuberculin (either PPD RT23 SSI, 2 Tuberculin units/0.1 mL, solution for injection (SSI, Copenhagen Denmark) or an equivalent local tuberculin preparation)
    (iii) Positive T SPOT™ -TB (Elispot) test
    (iv) Chest x-ray (taken within the previous 2 years) suggesting healed or active TB
    6. Current or ex-smokers with a smoking history of at least 10 years
    7. FEV1 of 30-60% of the predicted normal value (pre-bronchodilator), according to the European Community for Coal and Steel, and a FEV1/FVC ratio of <70%
    When the patient returns to clinic for Visit 2, the following criteria should be fulfilled before they are considered eligible for randomisation.
    8. Sputum producers with a history of chronic expectoration on most days of most weeks of the year (sputum colour, as recorded by the study site staff at Visit 2, of grade =3 (Bronkotest© diary card)
    9. Patients must have a daily score for amount of sputum produced (from Bronkotest© diary card) of =2, for any 7 consecutive days during the baseline period (from Visit 1)
    10. Patients must not have experienced exacerbation of their COPD since Visit 1
    11. During the baseline period, patients must have been able to show that they have completed the diary card satisfactorily and that they are willing and able to complete all remaining study procedures
    12. Patients must not have taken any disallowed medications during the baseline period (since signing consent)
    E.4Principal exclusion criteria
    1. Pregnant or lactating females
    2. A history of asthma or seasonal allergic rhinitis with disease onset before 40 years of age
    3. Concomitant diagnosis of clinical bronchiectasis, sarcoidosis or pulmonary disease other than COPD
    4. Requirements for regular oxygen therapy
    5. Any other clinically significant disease or disorder (including insulin-dependent diabetes and active peptic ulceration) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study
    6. Known HIV infection or positive tests for Hepatitis B or C
    7. An exacerbation of COPD (defined as, an increase in respiratory symptoms requiring hospitalisation and/or a course of oral glucocorticosteroids and/or antibiotics (either prescribed or self-administered) within 8 weeks of Visit 1
    8. Use of antibiotics within 4 weeks of Visit 1
    9. Receipt of live, or live attenuated, vaccines within 4 weeks of Visit 1
    10. History of malignancy and neoplastic disease (however, patients who have been successfully treated for basal or squamous cell carcinoma of the skin more than 5 years ago, may be included)
    11. Chronic liver or renal disease
    12. Liver function tests (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or bilirubin) above the upper limit of normal (ULN) of central laboratory reference range at Visit 1
    13. Any clinically significant deviations (as judged by the investigator) from the central laboratory reference ranges for other clinical chemistry, or haematology parameters at Visit 1
    14. History of excessive alcohol consumption or current consumption of more than 28 units per week (male) or 21 units per week (female). (One unit of alcohol is equivalent to half a pint of ordinary strength beer, lager, or cider; a quarter of a pint of strong beer or lager; one small glass of wine; one single measure of spirits)
    15. Abnormal ECG for this patient population, as judged by the investigator including a QTc >450 ms
    16. History of retinopathy
    17. A history of hypersensitivity or intolerance to any ingredient in the investigational product
    18. Use of disallowed medications (See Section 3.7.1 for detailed list)
    19. Scheduled in-patient surgery or hospitalisation during the course of the study
    20. History of or current drug abuseas judged by the investigator
    21. Participation in another clinical study involving an investigational product within 90 days of Visit 1
    22. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    23. Previous enrolment or randomisation to treatment in the present study
    E.5 End points
    E.5.1Primary end point(s)
    The primary variables are neutrophil counts in sputum, inflammatory markers in blood and sputum, lung function change from baseline, symptoms compared to baseline (captured on Bronkotest© diary card), quality of life compared to baseline, as captured by the SGRQ and exercise tolerance compared to baseline as captured by the 6MWT.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality Of Life
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 date of database lock, which is the timepoint after which no patient will be exposed to study-related activities. This has been selected as the definition of the end of the study to ensure consistency with trials conducted outside the European Union.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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 Information not present in EudraCT
    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 2005-12-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    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)
    According to local practice
    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 Decision2006-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-11-16
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