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    Summary
    EudraCT Number:2008-001530-27
    Sponsor's Protocol Code Number:D0520C00009
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-17
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-001530-27
    A.3Full title of the trial
    A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis
    A.4.1Sponsor's protocol code numberD0520C00009
    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.3.1Product nameAZD9668
    D.3.2Product code AZD9668
    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.3.8INN - Proposed INNnone
    D.3.9.1CAS number none
    D.3.9.2Current sponsor codeAZD9668
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Cystic Fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    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 investigate whether AZD9668 shows evidence of efficacy in CF patients by investigation of:
    - Absolute and differential neutrophil count in induced sputum.
    - Signs and symptoms of CF (including effects on QoL)
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To investigate the effect of AZD9668 on NE activity in sputum
    - To investigate the effect of AZD9668 on other inflammatory markers in sputum
    - To investigate the effect of AZD9668 on inflammatory markers in blood
    - To investigate the safety and tolerability of 28 days’ dosing with AZD9668 in CF patients
    - To confirm AZD9668 exposure in plasma and induced sputum
    - To investigate the effect of AZD9668 on urine desmosine (marker of tissue degradation).

    An optional objective in this study is to collect samples for possible retrospective pharmacogenetic analysis to investigate the influence of genotype on pharmacokinetics (and pharmacodynamic response where appropriate). The results of the pharmacogenetic analysis will be reported separately from the main Clinical Study Report (CSR).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study patients must fulfil the following criteria:
    1. Provision of informed consent/assent prior to any study specific procedures
    2. Male or post-menopausal/surgically sterile female (defined as amenorrhoeic for 12 months and follicle stimulating hormone (FSH) plasma concentration within the post-menopausal range as defined by the laboratory) or surgically sterile (defined as having undergone bilateral oophrectomy and/or hysterectomy; tubal ligation on its own is not adequate), aged ≥16 years
    3. Have a clinical diagnosis of CF with a FEV1 ≥40%
    4. Have normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
    5. Have normal renal function, defined as calculated glomerular filtration rate of >70 mL/min (as calculated by the Cockcroft-Gault formula) unless the investigator considers an abnormality to be clinically irrelevant.
    E.4Principal exclusion criteria
    Patients must not enter the study if any of the following exclusion criteria are fulfilled:
    1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca/delegate staff and/or staff at the study site)
    2. Previous randomisation of treatment in the present study
    3. 'Participation (defined as administration of at least one dose of investigational product) in another clinical study within 12 weeks of Visit 1
    4. Significant liver disease
    5. Alanine aminotransferase / aspartate aminotransferase (AST) level ≥ 1.5 x ULN at Visit 1
    6. Any other non-CF-related lung disease that may interfere with study assessments, in the opinion of the investigator
    7. An acute exacerbation (defined as an increase in respiratory symptoms requiring hospitalisation and/or a course of oral glucocorticosteroids and/or antibiotics, either prescribed or self administered); or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics in the 6 weeks prior to Visit 2
    8. Other acute infections requiring treatment in the 4 weeks prior to Visit 2
    9. Lung transplant patients
    10. Any ECG abnormality (including a QTc > 450 msec for males and > 470 msec for females, or any arrhythmia) which in the opinion of the investigator may put the patient at risk or interfere with the study assessments
    11. Use of prohibited medications as detailed in Section 6.5
    12. Patients using percutaneous intravenous catheters
    13. Known to be infected with Burkholderia cepacia complex
    14. Any other clinical disease or disorder, which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study
    15. History of excessive alcohol consumption or chronic alcohol induced disease
    16. Donation of >1350 mL of blood in the 12 months or 500 mL of blood in the 3 months before Visit 2
    17. Suspected or known risk of the patient transmitting human immunodeficiency virus, hepatitis B or C
    18. Scheduled in-patient surgery or hospitalisation during the course of the study
    E.5 End points
    E.5.1Primary end point(s)
    - Absolute and differential neutrophil cell count in sputum
    - Lung function (FEV1, slow vital capacity (SVC) forced vital capacity [FVC], forced expiratory flow between 25 and 75% of forced vital capacity [FEF25-75])
    - Weight of 24 hour sputum collection (pre-treatment versus end of treatment)
    - Symptom scores from diary card (BronkoTest© diary)
    - Quality of Life (Quittner questionnaire)
    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 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.8.5The 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 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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 70
    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 Decision2008-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-04
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