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    Summary
    EudraCT Number:2008-000311-15
    Sponsor's Protocol Code Number:D9831C00002
    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:2008-05-06
    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 number2008-000311-15
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
    A.4.1Sponsor's protocol code numberD9831C00002
    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 AZD1981 250 mg
    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.3.9.1CAS number 802904-66-1
    D.3.9.2Current sponsor codeAZD1981
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    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 is to evaluate the effects of 4 weeks treatment with AZD1981 on histology (lung tissue biopsy) and cellularity (broncho alveolar lavage [BAL]) and 3 weeks treatment with AZD1981 on cellularity (induced sputum) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    1. To evaluate the efficacy of AZD1981 compared with placebo on COPD symptoms and functional endpoints in patients with moderate to severe COPD
    2. To evaluate safety and tolerability of AZD1981 in patients with moderate to severe COPD
    3. To describe the plasma exposure of AZD1981 in patients with moderate to severe COPD.
    The Exploratory objectives are:
    1. To retain a sample of plasma, BAL and sputum for potential future retrospective analysis of mediators (multiplex) relevant to the mechanism of inflammation in COPD
    2. To collect pharmacogenetic (PGx) samples (optional) for possible retrospective pooled analysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion into the run in period of the study patients must fulfil all of the following criteria:
    1. Provision of informed consent prior to any study-specific procedure
    2. Men or women ≥40 years of age. Women must be either permanently surgically sterilised or post menopausal, ie, amenorrhoeic for 12 months and FSH within the post menopausal range as defined by the central laboratory
    3. Clinical diagnosis of COPD, with symptoms for more than 1 year before visit 1a
    4. BMI between 18 and 35 kg/m2 and a minimum weight of 50 kg
    5. Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year=20 cigarettes smoked per day for 1 year)
    6. FEV1 40-80% of the predicted normal (PN) value post-bronchodilator
    7. FEV1/FVC post bronchodilator <70%
    8. Patients who are judged to be able to discontinue all non-allowed medication (see Table 5, Table 6 and Table 7)
    9. Use of β2-agonists and/or anticolinergics as reliever medication within 1 year of visit 0
    For inclusion in this genetic research, patients must fulfil the following criteria:
    10. Provision of informed consent for genetic research: If a patient declines to participate in the genetic research, there will be no penalty or loss of
    benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
    For inclusion into randomised period of the study patients must fulfil the following criterion:
    11. Lung biopsy samples must be of sufficient quality at visit 1b (as judged by
    independent pathology assessment)
    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), including human immunodeficiency virus or Hepatitis B or C infection or previous bone marrow transplant, 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. History of or current clinically relevant arrhythmia, heart block, intraventricular conduction delay or other clinically relevant ECG abnormalities, or unstable angina, New York Heart Association Class III-IV heart failure, as judged by the investigator
    4. Malignancy or neoplastic disease within the past 5 years, other than treated basal 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. Requirement for long term oxygen therapy
    8. An exacerbation of COPD (use of antibiotics and/or systemic glucocorticosteroid (GCS) and/or hospitalisation related to COPD) within 30 days of visit 1a
    9. Use of oral or systemic GCS within 30 days prior to visit 1a, or during the run-in period
    10. Known or suspected hypersensitivity to study therapy or excipient of the investigational product
    11. History of current alcohol abuse or drug abuse, as judged by the investigator
    12. Clinical judgement by the investigator that the patient should not participate in the study
    13. Participation in another study involving study drug administration within 3 months of visit 1a, or within 1 month of visit 1a if the study did not involve study drug administration (eg, method development study)
    14. Blood donation (>450 mL) within 3 months of visit 1a
    15. Scheduled inpatient surgery or hospitalisation during the study
    16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    17. Previous randomisation into the study
    18. Contraindication for bronchoscopy, including contraindications or hypersensitivity to medications used as pre medication for bronchoscopy
    19. Contraindication for biopsy, including uncontrolled coagulopathies that would increase the bleeding risk
    E.5 End points
    E.5.1Primary end point(s)
    - Aggregate pathology score
    - Cell counts of BAL fluid and induced sputum
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 concerned3
    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 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 study is defined as database lock.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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)
    After 4 weeks treatment (at visit 6) patients will return to their usual COPD therapy.
    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 Decision2008-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-20
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