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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7337   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-002584-90
    Sponsor's Protocol Code Number:D1511C00002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2005-002584-90
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Two-Way Crossover Study in Healthy Volunteers to Investigate the Effect of Oral Dosing with AZD8309 on Airway Inflammation as Assessed in Induced Sputum after Challenge with Inhaled Lipopolysaccharide (LPS).
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberD1511C00002
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 nameAZD8309
    D.3.2Product code AZD8309
    D.3.4Pharmaceutical form Oral solution
    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 INNN/A
    D.3.9.1CAS number Lab codes:
    D.3.9.2Current sponsor codeAZD8309
    D.3.9.3Other descriptive nameChemical Name:Di-substituted thiazolopyrimidine potassioum salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number17.25
    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 placeboOral solution
    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 (COPD)
    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 this study is to investigate the effect of AZD8309 compared to placebo treatment on neutrophil numbers in induced sputum after administration of inhaled LPS.
    E.2.2Secondary objectives of the trial
    1. Investigate the effect of AZD8309 compared to placebo treatment on soluble mediators in induced sputum after administration of inhaled LPS.
    2. Investigate the effect of AZD8309 compared to placebo treatment on cells and inflammatory mediators in blood after administration of inhaled LPS.
    3. Generate additional safety and tolerability data for AZD8309 dosed at 300 mg bid.
    4. Preliminary investigation of the relationship between exposure and a change in neutrophils in sputum may be undertaken if appropriate.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of informed consent
    2. Able to comply with study procedures
    3. Healthy male or female of non-child bearing potential (defined as cessation of regular menses for more than 12 months and an FSH of >20 IU/L or surgically sterile)
    4. Aged 18-50 years inclusive
    5. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and minimum body weight of 50 kg.
    6. Have a normal physical examination, laboratory values, 12-lead ECG and vital signs (blood pressure and pulse), unless the Investigator considers an abnormality to be clinically irrelevant.
    7. Be non-smokers, or ex-smokers who have not smoked (or used any other nicotine products) in the 12 months preceding Visit 1 with a pack-year history of less than 10.
    8. Be non-atopic as defined by negative skin prick test to common aeroallergens either from a test conducted in the previous 3 years of Visit 1 or at Visit 1 screening.
    9. Demonstrate an FEV1 =80% of their predicted normal
    10. Demonstrate no evidence of airway obstruction by having and FEV1/FVC ratio > 70%.
    11. Have normal airway responsiveness to inhaled methacholine with a PC20=16 mg/ml.
    12. Have negative screens for serum Hepatitis B surface antigen, Hepatitis C antibodies and HIV.
    13. Be able to produce a minimum of 200 µL sputum volume after induction with inhaled hypertonic saline.
    14. Have a sputum eosinophilia < 2% and a sputum neutrophilia < 80%. This sputum neutrophil count is based on the published sputum cell counts in healthy volunteers by Belda et al., 2000. 80% is the mean cell differential plus 2 S.D.s
    E.4Principal exclusion criteria
    1. A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs eg, haematological, gastrointestinal, hepatic or renal disease etc.
    2. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    3. Previous enrolment or randomisation of treatment in the present study.
    4. A definite or suspected personal or family history of intolerance or hypersensitivity to drugs and/or their excipients, judged to be clinically relevant by the Investigator.
    5. Surgery or significant trauma within 3 months of Visit 1.
    6. Participation in any clinical study with an investigational drug in the 4 months prior to Visit 1, or participation in a study with a new formulation of a marketed drug in the 3 months prior to Visit 1, or participation in a methodology study in the month prior to Visit 1 (Note: participation is identified as the completion of a treatment –related visit).
    7. Donation of more than 1200 mL of blood within 12 months of Visit 1, or donation of blood in total > 500 mL within 3 months prior to Visit 1.
    8. Symptoms of any clinically significant illness within 2 weeks prior to Visit 1.
    9. Use of any prescribed medication in the 3 weeks prior to Visit 1 (other than hormone replacement therapy (HRT) or over-the-counter preparations (other than paracetamol, maximum 1 g qid) or any herbal preparations and vitamins in the previous 7 days, at the investigators discretion.
    10. Subjects who are pyrexial with a body temperature of greater than 37.7oC on days 1 or 3, or as judged by the Investigator.
    11. A significant history of alcohol abuse or consumption of more than 28 units (male) or 21 units (female) of alcohol per week.
    12. A significant history of drug abuse (including benzodiazepines) or positive drugs of abuse test.
    13. Subjects who admit to belonging to a high risk group for HIV infection according to the site’s standard practice.
    14. Anticipated difficulty with venous access.
    15. Subjects who in the opinion of the Investigator should not, for reasons of the safety or compliance, participate in the study.
    16 Symptoms, signs or laboratory findings suggestive of an ongoing infective illness as judged by the investigator at the time of enrolment
    17 A history of respiratory disease including asthma
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be a measurement of neutrophil numbers in induced sputum after administeration of inhaled lipopolysaccharide (LPS), in subjects after administration of AZD8309 compared with placebo.
    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 Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Yes
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 after completion of the study will be performed according to local medical practices.
    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 Decision2005-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-04-06
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