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    Summary
    EudraCT Number:2007-002722-29
    Sponsor's Protocol Code Number:D5897C00004
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-03
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-002722-29
    A.3Full title of the trial
    A 4-week, open-label, randomized, multi-centre, parallel-group study evaluating the safety and efficacy of 4 actuations Symbicort (budesonide/formoterol) HFA pMDI 40/2.25ug twice daily, with and without spacer, in children (6-11 years) with asthma
    A.3.2Name or abbreviated title of the trial where available
    SPACER
    A.4.1Sponsor's protocol code numberD5897C00004
    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 nameSymbicort (budesonide/formoterol) HFA pMDI with Spacer AeroChamber PLUS VHC
    D.3.4Pharmaceutical form Inhalation vapour*
    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 51333-22-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.25
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to show that Symbicort® pMDI 40/2.25 μg (delivered dose), 4 actuations twice daily (bid) with spacer has a similar systemic steroid potency as Symbicort pMDI 40/2.25 μg, 4 actuations bid in children with asthma.
    E.2.2Secondary objectives of the trial
    to compare the clinical efficacy and safety of Symbicort pMDI 40/2.25 μg, 4 actuations bid with or without the spacer in children with asthma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For enrolment in the study patients must fulfil all of the following criteria at Visit 1:
    1. Out-patients of either sex, 6 - 11 years
    2. Signed Informed Consent from both the patient and the patient’s parent/legal guardian must be obtained prior to any study-related procedures. If the patient cannot read and write, oral consent from the patient is required.
    For inclusion in the study run-in period patients must fulfil all of the following criteria at Visit 2:
    3. Asthma diagnosed according to the American Thoracic Society (ATS) definition at least 6 months prior to Visit 2.
    4. PEF ³ 50 % of predicted normal values (pre-bronchodilator)
    5. Daily use of inhaled glucocorticosteroids (GCS of any brand) for ≥3 months prior to Visit 2
    6. During 30 days prior to Visit 2, the dose of any brand of inhaled GCS should have been constant and within the range of 375- 800 μg.
    7. Ability to use pMDI, spacer, and peak flow meter correctly
    For randomization into the study patients must fulfil all of the following criteria at visit 3:
    8. Run-in diary data for mPEF recorded on at least 7 (any 7) of the last 10 days of the run-in period (including the morning of the first day of Visit 3)
    9. A mean mPEF during the last 7 days of the run-in period (including the value obtained in the morning of the first day of Visit 3) of 50 to 85% of post-bronchodilatory PEF obtained after administration of inhaled terbutaline sulphate (Bricanyl Turbuhaler; 2 x 0.5 mg/inhalation) at Visit 2 or 3.
    10. Total asthma symptom score (night-time plus daytime) of ≥1 on at least 4 of the last 7 days of the run-in period (not including the recording in the morning of the first day of Visit 3).
    11. No change in asthma treatment during the run-in period
    12. A successful baseline urine collection, as judged by the investigator, before randomization.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Use of oral, parenteral, or rectal GCSs within 30 days prior to Visit 2
    2. Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to Visit 2.
    3. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patients ability to participate in the study.
    4. Known or suspected hypersensitivity to study therapy or excipents of the investigational products.
    5. Current use of any β2-blocker therapy, including eye-drops.
    6. Planned hospitalisation during the study.
    7. Any clinically relevant abnormal findings in physical examination, vital signs, or urinalysis at baseline visit, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
    8. When applicable, girls of childbearing potential who are not using acceptable contraceptives, as judged by the investigator.
    9. Conditions associated with poor compliance.
    10. Participation in another clinical study of any investigational drug 30 days prior to or during this study.
    11. Previously randomized into the study.
    12. Patient’s parent/legal guardian should not be involved in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    E.5 End points
    E.5.1Primary end point(s)
    24-hour Urine Free Cortisol (UFC) excretion
    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 No
    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) 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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Symbicort (budesonide/formoterol) pMDI
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Last visit of 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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 100
    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 Decision2007-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-12
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