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    Summary
    EudraCT Number:2010-020747-13
    Sponsor's Protocol Code Number:D0540C00014
    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:2010-06-01
    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 number2010-020747-13
    A.3Full title of the trial
    A double-blind, placebo controlled, randomised, parallel group phase IIa study to investigate the efficacy, tolerability, and safety of different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis patients out of pollen season in a nasal allergen challenge model
    A.4.1Sponsor's protocol code numberD0540C00014
    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 nameAZD8848
    D.3.2Product code AZD8848
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 866269-28-5
    D.3.9.2Current sponsor codeAZD8848
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.1 to 1
    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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic Rhinitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    To compare the efficacy of 60 μg AZD8848 once weekly with 20 μg AZD8848 three (3) times weekly and with placebo when administered intranasally to seasonal allergic rhinitis patients out of season in a nasal allergen challenge model.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:

    - To investigate the tolerability and safety of AZD8848 administered intranasally up to three (3) times weekly for one month to seasonal allergic rhinitis patients out of season.

    - To investigate the pharmacodynamic effects of AZD8848 on systemic and local biomarkers.

    - To investigate the influence of butyrylcholinesterase genotype on pharmacodynamic responses where appropriate.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The participation in the genetic research activity is an optional part of the study. Patients must give separate informed consent before a blood sample is taken. Pharmacogenetic data will be reported separately from the Clinical Study Report.

    Objective:
    - To investigate the influence of butyrylcholinesterase genotype on pharmacodynamic responses where appropriate.
    E.3Principal inclusion criteria
    For inclusion in the study patients should fulfil the following criteria:

    1. Provision of signed and dated informed consent prior to any study specific procedures
    2. Female and/or male patients, aged 18 to 55 years inclusive. Females must be of non-childbearing potential or must have been stable on highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen method, with additional use of a condom by male partner, until 3 months after the last dose
    3. Females must have a negative pregnancy test and a date of last menstruation consistent with non-pregnancy at Visit 1
    4. Have a body mass index (BMI) between 19 and 30 kg/m2 and a weight between 50 and 100 kg
    5. Seasonal allergic rhinitis patients out of pollen season
    6. Have a history of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years
    7. Have presence of allergic sensitivity to birch and/or timothy grass pollen verified by a positive skin prick test documented within the previous 24 months or at Visit 1
    8. Have a need of treatment for their nasal symptoms during the pollen season
    9. Have reaction to an individually titrated dose of nasal allergen resulting in at least 5 sneezes and/or recorded score of 2 or more on a scale from 0 to 3 in either of the symptoms nasal blockage or runny nose
    10. Be able to metabolise AZD8848 (an in vitro screening assay will determine BChE activity in a blood sample taken at Visit 1 using a pre-defined limit)
    E.4Principal exclusion criteria
    Patients should not enter the study if any of the following exclusion criteria are fulfilled:

    1. Any clinically relevant disease and/or abnormality (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 clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the Investigator, may put the patient at risk because of participation in the study
    3. QTcF > 450 ms (confirmed with repeated measurements) at Visit 1
    4. Rhythm, conduction (e.g. intermittent or constant Bundle branch block; Intraventricular conduction disturbance with repolarization changes; intermittent or constant AV block [including 1st degree AV block with PR interval > 220 msec, 2nd or 3rd degree AV block]); or morphologic changes affecting repolarization (eg, flat, biphasic or inverted T waves in primary lead V2), that may limit ability to measure QTc and assess changes in QTc intervals or QTc morphology
    5. History of additional risk factors for Torsade de pointes (eg, heart failure, hypokalemia, family history of Long QT syndrome, or sudden death)
    6. Medical history suggesting or confirming abnormal immune function, apart from allergic rhinitis
    7. Family history (parent or sibling) of autoimmune disease including, but not limited to, Wegeners granulomatosis, systemic lupus erythematosus, rheumatoid arthritis, Sjögren´s syndrome, multiple sclerosis, autoimmune thrombocytopenia, primary biliary cirrhosis, Mb Crohn, ulcerative colitis, type 1 diabetes or other autoimmune disease considered relevant by the Investigator
    8. History of asthma
    9. Symptomatic perennial allergic or non-allergic rhinitis, except for cat and dog sensitivity under the condition that these patients will not be exposed to cats and dogs during the study up until Visit 16, as judged by the Investigator
    10. History of or ongoing immunotherapy, including but not limited to specific immunotherapy (SIT)
    11. Topical or inhaled glucocorticosteroid treatment within 1 month prior to Visit 1
    12. Systemic glucocorticosteroid therapy for any reason during 6 weeks prior to Visit 1
    13. Antihistamine treatment within 1 week prior to Visit 1
    14. Use of any medication (including vaccinations, over-the-counter drugs, herbal medicines and nutritional supplements,) or therapy within 2 weeks prior to Visit 2 (or longer if the medication has a half-life long enough to potentially expose the patient to any significant systemic exposure that may interfere with the objectives of the study or the safety of the patients) as judged by the Investigator, except for occasional intake of paracetamol
    15. Suspicion of Gilbert’s syndrome
    16. A suspected/manifested infection according to World Health Organisation (WHO) risk groups 2, 3, or 4
    17. Positive results on screening tests for serum Hepatitis B surface antigen, Hepatitis C antibodies, and/or HIV
    18. Any upper respiratory tract infection (bacterial, viral or fungal infections of the airways) or any other clinically significant illness within 2 weeks prior to Visit 2 being symptomatic enough to affect study conduct or the wellbeing of the patient as judged by the Investigator
    19. Structural abnormalities of the nose or nasal disorder symptomatic enough to cause significant nasal obstruction as judged by the Investigator
    20. Known or suspected hypersensitivity to investigational drug or any excipients
    21. Definite or suspected personal history of significant adverse drug reactions/any anaphylactic reaction
    22. Use of drugs with CYP3A4 enzyme inducing properties, including herbal medicines such as St John’s Worth, within 3 weeks prior to Visit 2
    23. History of or current alcohol and/or drug abuse, as judged by the Investigator, or positive drugs of abuse test
    24. Planned surgery, dental procedure, or hospitalization during the study, and/or major surgery or significant trauma within 3 months of Visit 1
    25. Participation in another study within 3 months before the start of the present study (or within 1 month for methodology studies in which no drugs were administered)
    26. Donation of blood within 2 months prior to Visit 1 or donation of more than
    1350 mL within 12 months prior to Visit 1
    27. Patients who, in the opinion of the Investigator, should not participate in the study
    28. Pregnancy or lactation
    29. Detection of anti-PR3 autoantibodies in the blood
    30. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study centre)
    31. Previous randomisation of treatment in the present study
    32. History of habitual nicotine use equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day), as judged by the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    - Reflective Total Nasal Symptom Score (TNSS) during allergen challenge
    - Peak Nasal Inspiratory Flow (PNIF) during allergen challenge

    Pharmacodynamics:
    - Blood: CXCL-10 (IP-10) and additional exploratory biomarkers
    - Nasal lavage: CXCL-10 (IP-10), myeloperoxidase, α2-macroglobulin, tryptase, eosinophilic cationic protein (ECP) and additional exploratory biomarkers

    Safety:
    - Incidence and nature of Adverse Events
    - Instantaneous Total Nasal Symptom Score (TNSS) during treatment period
    - Peak Nasal Inspiratory Flow (PNIF) during treatment period
    - Electrocardiogram parameters, blood pressure, pulse, physical examination, clinical chemistry, haematology, urinalysis, clinical inspection of the nose, auto-antibodies
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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
    End of study is defined as final data base lock which will be performed after the last telephone contact has been completed (Visit 19).
    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 days0
    E.8.9.2In all countries concerned by the trial years0
    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 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) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state80
    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)
    A long-term safety follow-up after ended dosing is included in the trial
    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 Decision2010-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-10
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