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    Summary
    EudraCT Number:2005-000372-41
    Sponsor's Protocol Code Number:D5890L00012
    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:2005-04-05
    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 number2005-000372-41
    A.3Full title of the trial
    Real life effectiveness in asthma of Symbicort® Single Inhaler Therapy (RELEASE)
    A.3.2Name or abbreviated title of the trial where available
    RELEASE
    A.4.1Sponsor's protocol code numberD5890L00012
    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 UK Limited
    B.1.3.4CountryUnited Kingdom
    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.2.1.1.1Trade name Symbicort Turbohaler 200/6
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Turbohaler 160/4.5 ug/inhalation
    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 INNBudesonide
    D.3.9.1CAS number S1 333-22-3
    D.3.9.3Other descriptive nameBudesonide 160ug/inhalation
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFormoterol Fumarate Dihydrate
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFormoterol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This is a Phase IIIb Trial to be conducted in adult, uncontrolled asthmatic patients.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10003553
    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 the study is to compare Symbicort® (budesonide 160 µg/inhalation and formoterol fumarate dihydrate 4.5 µg /inhalation) as Single Inhaler Therapy, with a Subject’s previous therapy (including low dose inhaled corticosteroids), by assessment of the changes in the Asthma Control Questionnaire (ACQ) in uncontrolled asthmatic Subjects.
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    For inclusion in the study run-in period Subjects must fulfil the following criteria:
    1. Provision of written informed consent.
    2. Female or male aged at least 18 years.
    3. Confirmed diagnosis of asthma (minimum of 6 months documented history prior to visit 1).
    4. Currently receiving a daily dose of 200 to 1000 µg of BDP or 100 to 500 µg of fluticasone or 200 to 800 µg of budesonide or equivalent for at least 4 weeks.
    5. Subjects, identified by the investigator, or during routine asthma management, requiring review of their current asthma treatment.
    6. The Subject needs to be able to read and to be fluent in English.

    For inclusion in the study treatment period Subjects must fulfil the following criteria:
    7. At least 1 positive answer on the RCP-3 questionnaire at visit 2.
    8. No asthma exacerbations during the run-in period (see section 3.3.5.1 for definition of an asthma exacerbation).
    9. No changes deemed necessary in existing asthma medication during the run-in period.
    E.4Principal exclusion criteria
    1. Documented history of Chronic Obstructive Pulmonary Disease.
    2. PEF < 50% of predicted normal value.
    3. Any non-asthma related, clinically significant abnormal finding in physical examination and/or vital signs at visit 1, which in the opinion of the Investigator, may put the Subject at risk because of his/her participation in the study.
    4. Use of oral, rectal or parenteral glucocorticosteroids (GCS) 30 days prior to visit 1.
    5. Women who are pregnant, breast-feeding or planning a pregnancy during the study. Women must be post-menopausal (at least 1 year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the Investigator.
    6. Any respiratory tract infection affecting the asthma within 30 days prior to visit 1, as judged by the Investigator.
    7. Current use of any ß-blocker therapy (including eye drops).
    8. Any significant disease or disorder (e.g. cardiovascular, pulmonary {other than asthma}, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) 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.
    9. Planned in-patient hospitalisation during the course of the study.
    10. Subjects not considered capable, as judged by the Investigator, of following the instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason.
    11. Previous enrolment or randomisation of treatment in the present study.
    12. Subjects who have participated in another clinical study within 90 days of visit 1.
    13. Known or suspected hypersensitivity to active ingredients of study medication or excipients.
    14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site).
    15. Smoking, current or previous with a smoking history of more than 10 pack years (one pack year = 1 pack (20 cigarettes) per day for 1 year or equivalent)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is the change in ACQ score from baseline (visit 2) to the average value of available data for visits 3-5. In addition, the change in ACQ score from baseline (visit 2) to 4 weeks (visit 3) will be analysed to assess whether Symbicort® Single Inhaler Therapy provides an early onset of action.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observational
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 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 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
    The end of the study is defined as database lock, which is the true point after which no patient will be exposed to study related activities.
    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 months2
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-04-05. Yes
    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 state500
    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 (completed or discontinued) will be performed according to local medical practice.
    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 Decision2005-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-01-31
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