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    Summary
    EudraCT Number:2007-003962-16
    Sponsor's Protocol Code Number:D3540C00005
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-13
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2007-003962-16
    A.3Full title of the trial
    A 4-week double-blind, placebo-controlled, randomised, parallel group phase IIa study to assess the tolerability/safety and efficacy of inhaled AZD4818 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
    A.3.2Name or abbreviated title of the trial where available
    TOP
    A.4.1Sponsor's protocol code numberD3540C00005
    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 AZD4818 Turbuhaler
    D.3.4Pharmaceutical form Inhalation powder
    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.3.9.1CAS number 923276-31-7
    D.3.9.2Current sponsor codeAZD4818 Turbuhaler
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 placeboInhalation powder
    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
    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 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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 inhaled AZD4818 delivered via a dry powder inhaler, Turbuhaler®, in COPD patients by assessment of:
    . incidence and nature of adverse events (AE)
    . Electro Cardio Graphic (ECG) parameters, vital signs, and laboratory assessments (clinical chemistry, haematology, and urin analysis parameters).
    E.2.2Secondary objectives of the trial
    To evaluate the effects of inhaled AZD4818 in COPD patients compared with placebo on multiple parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study at Visit 1 the patients must fulfil all of the following criteria:
    1. Provision of informed consent
    2. Men, or women ≥ 40 years of age. Women must be either surgically sterilised
    or post-menopausal i.e. amenorrhoeic for 12 months and follicle-stimulating
    hormone (FSH) plasma concentration is within the postmenopausal range as
    defined by the central laboratory
    3. Be able to inhale from the Turbuhaler according to given instructions
    4. Body mass index between 18 and 30 kg/m2 and a minimum weight of 50 kg
    5. Clinical diagnosis of COPD, with symptoms for more than 1 year
    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)
    7. FEV1 40 to 80 % of the predicted normal value (post-bronchodilator) and
    post-bronchodilator FEV1/FVC < 70 %
    8. Patients that can discontinue non-allowed concomitant medication.
    9. A history of use of short acting β2-agonist or anticholinergics as rescue medication
    For inclusion in the study at Visit 2 the patients must fulfil all the following criterion:
    1. A score ≥ 1 on Breathlessness score on at least half of the numbers of days of
    the run-in period.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    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 tuberculosis defined as at least one of the following;
    a) positive Mantoux-test. (>5 mm in unvaccinated individuals and >10 mm in
    individuals with previous BCG-vaccination), and positive QuantiFERON® TB Gold test (QFT, see Mori T et al 2004.
    NB A QFT will only be performed after a positive Mantoux-test. If the readout of the QFT is negative this will overrule the positive Mantoux test, hence no active TB.
    b) suspicion of active tuberculosis on
    chest X-ray taken within last 6 months.
    NB Abnormal chest X-ray consistent with past TB or a history of prior pulmonary,
    or extrapulmonary TB, that has been adequately treated is not an exclusion
    criterion.
    4. History of current clinically relevant arrhythmia, heart block, intraventricular
    conduction delay or other clinical relevant ECG abnormalities, or unstable angina,
    NYHA Class III-IV heart failure, as judged by investigator
    5. Malignancy within the past 5 years
    6. Disease history suggesting reduced or abnormal immune function
    7. 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
    8. QTcF >450 ms or QT >500 ms at Visit 1
    9. A history of additional risk factors for Torsade de pointes (e.g., heart failure,
    hypokalemia, family history of Long QT syndrome)
    10. Requirement for regular oxygen therapy
    11. An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or
    glucocorticosteroids (GCS) and/or hospitalization related to COPD) within 30
    days of Visit 1, or during the run-in period
    12. Use of oral or systemic glucocorticosteroids within 30 days prior to Visit 1, or
    during the run-in periodt
    13. Known or suspected hypersensitivity to study therapy or excipients (e.g., benzoate,lactose) of the investigational product
    14. History of or current alcohol abuse or drug abuse, as judged by the investigator
    15. Participation in another study involving drug administration within 3 months
    of Visit 1
    16. A suspected/manifested infection according to WHO risk classification 2, 3 or 4
    (See Appendix C)
    17. Positive results on screening tests for hepatitis B and C
    18. Known HIV infection, or patients who belong to a high risk group for HIV
    19. Scheduled in-patient hospitalization during the course of the study
    20. Donation of blood within 3 months or donation of plasma within 14 days prior
    to Visit 1
    21. Clinical judgement by the investigator that the patient should not participate in
    the study
    22. Previous randomization in this study
    23. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
    E.5 End points
    E.5.1Primary end point(s)
    No primary variable will be chosen. The primary objective of the study is tolerability and safety, which will be assessed by e.g. AE, ECG, vital signs, and laboratory 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.5.1Number of sites anticipated in the EEA10
    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 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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 60
    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)
    Treatment of the subject after participation in the trial has ended, will be upon the description of the investigator.
    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 Decision2007-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-06
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