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    Summary
    EudraCT Number:2008-004699-34
    Sponsor's Protocol Code Number:D4260C00008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-25
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-004699-34
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.

    Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística
    A.3.2Name or abbreviated title of the trial where available
    CYBER
    A.4.1Sponsor's protocol code numberD4260C00008
    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 number25
    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

    Fibrosis quística
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011763
    E.1.2Term Cystic fibrosis lung
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to investigate whether AZD1236 shows evidence of efficacy in CF patients by:
    • investigation of biomarkers (MMP-9 levels and TNF-α) in induced sputum
    • study signs and symptoms of CF compared to placebo
    E.2.2Secondary objectives of the trial
    • To assess MMP activity (MMP-9) and other inflammatory biomarkers in sputum
    • To investigate the safety and tolerability of 28 days’ dosing with AZD1236 in CF
    patients
    • To investigate AZD1236 exposure in plasma and sputum
    • To investigate the effect of AZD1236 on inflammatory markers in blood
    • To investigate the effects of AZD1236 on markers of tissue degradation
    • To investigate the effects of AZD1236 on markers of mucus hyper-secretion
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title of the genetic sub-study:
    "A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the Efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis"

    Date:
    8 July 2008

    Objectives:
    To carry out possible retrospective pharmacogenetic analysis to investigate the influence of genotype on pharmacokinetics (and pharmacodynamic response where appropriate).
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Be male or post-menopausal/surgically sterile female (total hysterectomy and/or bilateral total ophorectomy) > 18 years old
    3. Have a clinical diagnosis of cystic fibrosis with an FEV1 ≥40% of predicted normal
    4. Be able to comply with induced sputum procedure
    E.4Principal exclusion criteria
    1. Significant portal hypertension in the opinion of the Investigator
    2. 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
    3. Concomitant diagnosis of significant pulmonary disease other than CF-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis
    4. A clinical suspicion of active or latent tuberculosis defined as any of the following: positive tuberculosis test (such as Quantiferon GOLD), and/or suspicion of active or latent tuberculosis on chest X-ray taken within last 12 months, and/or past medical history of tuberculosis
    5. 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 4 weeks prior to Visit 2
    6. Vaccination (killed vaccine) within 1 week before each biomarker sampling (see Table 2). For live vaccine, the limit is 4 weeks before Visit 2. Vaccination is accepted 1 week after last dose (Visit 4)
    7. Acute respiratory infection with fever in the two weeks prior to Visit 2, or other acute infections requiring treatment with antibiotics, fungicides or anthelmintica in the 4 weeks before Visit 2
    8. Use of oral corticosteroids in the 8 weeks prior to Visit 2 (use of inhaled corticosteroids is allowed as long as dose remains stable in the 4 weeks before Visit 2)
    9. Use of antibiotics (systemic or nebuliser) in the 4 weeks prior to Visit 2 (except prophylactic treatment – acceptable if unchanged for 8 weeks prior to Visit 2), macrolides or tetracyclins not allowed
    10. Treatment with any immunomodulatory agents within 8 weeks prior to Visit 2
    11. Increased Cardiac Troponin I>Upper Limit of Normal (ULN) at screening (Visit 1)
    12. Any clinically relevant abnormal finding 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
    13. 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
    14. Patients with underlying musculoskeletal symptoms of unknown origin and patients with shoulder girdle musculoskeletal symptoms or Dupuytrens contracture symptoms as judged by the investigator
    15. Suspected or known risk of the patient transmitting HIV, hepatitis B or C via infected blood
    16. Known to be infected with Burkholderia cepacia
    17. Scheduled in-patient surgery or hospitalisation during the course of the study
    18. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    19. Previous randomisation of treatment in the present study
    20. Known or suspected hypersensitivity to study therapy or excipient of the investigational product.
    21. Participation in another clinical study involving an investigational product within 12 weeks of Visit 1
    If the patient participates in the genetic part of the study these exclusion criteria apply as well:
    1. Previous bone marrow transplant
    2. Whole blood transfusion within 120 days of the date of genetic sample collection
    E.5 End points
    E.5.1Primary end point(s)
    · Signs and symptoms
    Primary: Lung function by spirometry (FEV1, FVC, FEF25-75, IC, VC), symptom scores from BronkoTest© Diary card and Health-related quality of life (HRQL) from Cystic Fibrosis Questionnaire (CFQ-R) (Quittner et al 2000)
    · Biomarkers in sputum
    Primary: MMP-9 protein levels, differential cell count (absolute and percentage of neutrophils), inflammatory mediators (TNF-α)
    Secondary: MMP-activity (MMP-9), Other markers in sputum (including but not restricted to) including IL-8, IL-6, IL-1β, MCP-1, RANTES, LTB4, MMP-8,-9,-12, the mucus hyper-secretion marker MUC5A-C and the tissue degradation marker hydroxyproline
    · Biomarkers in blood
    Secondary: Differential cell counts and inflammatory markers (including but not restricted to) TNF-α, IL-6, IL-8, IL-1β, Serum Amyloid-A, high sensitivity c-reactive protein (hsCRP), and desmosine
    · Safety
    Adverse events reporting, vital signs, ECG, haematology, clinical chemistry, urinalysis
    · Biomarkers in urine
    Primary: Desmosine
    · Pharmacokinetics
    AZD1236 plasma and sputum concentrations
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 50
    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 Decision2008-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-28
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