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    Summary
    EudraCT Number:2009-014586-75
    Sponsor's Protocol Code Number:D0520C00020
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-01
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-014586-75
    A.3Full title of the trial
    A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60 mg AZD9668 Administered Orally Twice Daily to Subjects with Chronic Obstructive Pulmonary Disease (COPD) on Treatment with budesonide/formoterol
    A.4.1Sponsor's protocol code numberD0520C00020
    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 Film-coated 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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Symbicort
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameSymbicort
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROL FUMARATE
    D.3.9.1CAS number 43229-80-7
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    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 placeboCoated tablet
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD subjects by assessing effect on lung function and symptoms of COPD.
    E.2.2Secondary objectives of the trial
    To evaluate safety and tolerability of AZD9668 in COPD subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent prior to any study specific procedures at visit 1a

    2. Male, or female subjects (female subjects may be of non-childbearing potential (ie, post menopausal or surgically sterile) or of child bearing potential):
    - Women will be considered post menopausal if they are i) over 50 years old and have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments or ii) over 57 years old
    - Surgically sterile is defined as having undergone hysterectomy and/or bilateral oophrectomy and/or bilateral salpingectomy; tubal ligation on its own is not adequate
    - Women will be considered of child bearing potential if they are between menarche and menopause, and have not been permanently or surgically sterilised. All female subjects must have a serum pregnancy test at visit 1b and visit 7. Women of child bearing potential must undergo an additional urine pregnancy test at visit 2 prior to randomisation and must be using suitable methods of birth control. Further details of methods of birth control that are considered suitable for use are given in Section 5.1

    3. Aged 40-80 years inclusive

    4. Documented clinical diagnosis of COPD, according to GOLD guidelines with symptoms for ³1 year before visit 1b

    5. Subjects who have received ICS as monotherapy or in combination with any long acting bronchodilator in the last 3 months

    6. History of a least one COPD exacerbation, requiring a course of oral parenteral steroids and/or antibiotics within 4 weeks to 12 months before visit 1b

    7. Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year)

    8. FEV1/FVC <70% post-bronchodilator at visit 1b

    9. FEV1 ≥30 and <80% of the predicted normal value post-bronchodilator at visit 1b (GOLD stage II/III)

    10. Able to use the handheld electronic devices

    11. Total COPD symptom score ³2 per day for at least 7 days of the last 14 days before visit 2 (by totalling breathing, cough and sputum scores from the BCSS diary card)

    12. Complete morning recordings of daily FEV1 data at least 10 days of the last 14 days of the run-in period
    E.4Principal exclusion criteria
    1. Any clinically relevant disease or disorder eg, infectious/viral disease (including hepatitis B or C) cardiovascular, pulmonary other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, past or present, which in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study.

    2. Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension, or any other relevant cardiovascular disorder as judged by the Investigator

    3. Current diagnosis of asthma according to Global Initiative for Asthma (GINA) guidelines (GINA 2008)

    4. Malignancy or neoplastic disease within the past 5 years other than treated basal/squamous cell skin carcinoma or treated cervical cancer in situ

    5. Subjects who require long term oxygen therapy (LTOT)

    6. Worsening of COPD within 4 weeks prior to visit 1b and during the run-in period (defined as an increase in respiratory symptoms requiring hospitalisation and/or a course of oral glucocorticosteroids and/or increased usage/dose of inhaled steroids and/or antibiotic treatment)

    7. Acute infections requiring treatment in the 4 weeks prior to visit 1b and during the run-in period

    8. Any clinically relevant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis at visit 1b, which in the opinion of the Investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study

    9. A QTcB interval of >450 msec for males and >470 msec for females at visit 1b

    10. Any ECG abnormality (including arrhythmia), which in the opinion of the investigator may put the subject at risk or interfere with study assessments at visit 1b

    11. A past history of or current clinical or laboratory evidence of renal failure, or an estimated creatinine clearance of <50 mL/min (as calculated by the Cockcroft-Gault formula) at visit 1b

    12. ALT or AST level ≥ 1.5 x upper limit of normal (ULN) at visit 1b

    13. Pregnancy, breast-feeding or planned pregnancy during the study

    14. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

    15. Previous randomisation to treatment in the present study

    16. Known or suspected hypersensitivity to the investigational product or excipients or additional study drugs provided for the study (budesonide/formoterol and reliever medication)

    17. Participation (defined as administration of at least one dose of investigational product) in another clinical study, the last follow-up visit of which is within 12 weeks of visit 1b in this study

    18. Excessive alcohol consumption (as judged by the Investigator) or known drug abuse

    19. Previous participation in a study with AZD9668

    20. Scheduled elective surgery or hospitalisation during the course of the study

    21. Subjects scheduled for an intensive COPD rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part)

    22. Subjects with any contraindications to the use of budesonide/formoterol, according to the prescribing information in each participating country
    E.5 End points
    E.5.1Primary end point(s)
    Pre-bronchodilator FEV1 measured at clinic visits

    Lung function: FEV1 at clinic visits, (post-bronchodilator), Pre and post-bronchodilator FVC, FEV6 FEF25-75% and IC at clinic visits, PEF and FEV1 measured at home by the subject

    Signs and symptoms: EXACT, BCSS, Sputum colour assessed using Bronkotest© 5-point colour scale, Use of reliever medication

    Exercise capacity: ISWT (including Borg), ESWT (including Borg)

    Health Related Quality of Life: SGRQ-C

    Exacerbations: Exacerbations (including antibiotic use and/or systemic steroid use (oral or parenteral) and/or emergency room treatment and/or hospitalisation)
    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 No
    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.8.5.1Number of sites anticipated in the EEA85
    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 Yes
    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 study is defined as ”the last visit of the last subject undergoing the study”.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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) 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 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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    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 Decision2009-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-18
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