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    Summary
    EudraCT Number:2010-018315-15
    Sponsor's Protocol Code Number:D589GC00001
    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:2010-05-20
    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 number2010-018315-15
    A.3Full title of the trial
    A Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 μg bid with placebo, a 6-week efficacy and safety study in children aged 6 to <12 years with asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of efficacy and safety of Budesonide pMDI 160 μg compared to Placebo in children aged 6 to < 12 years with asthma for 6 weeks twice a day
    A.4.1Sponsor's protocol code numberD589GC00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01136382
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstra Zeneca AB
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountrySweden
    B.5.4Telephone number-
    B.5.5Fax number-
    B.5.6E-mailinformation.center@astrazeneca.com
    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 nameBudesonide pMDI
    D.3.2Product code Budesonide pMDI
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation No
    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 number80
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboPressurised inhalation
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 determine the efficacy of budesonide pressurized metered dose inhaler (pMDI) 160 µg twice a day (80 μg x 2 inhalations twice a day) as a single ingredient product over a 6-week period in children aged 6 to <12 years who demonstrate the need for inhaled glucocorticosteroid (ICS) controller therapy.
    E.2.2Secondary objectives of the trial
    The key secondary objective of this study is to determine the efficacy of budesonide pMDI 160 µg twice a day (80 μg x 2 inhalations twice a day) as a single ingredient product over a 6 week period in children aged 6 to <12 years who demonstrate the need for inhaled glucocorticosteroid (ICS) controller therapy by evaluating in clinic morning pre-dose forced expiratory volume in 1 second (FEV1).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent prior to conducting any study specific procedures.
    2. Is between the ages of 6 and <12 years (not having reached his/her 12th birthday at the time of Visit 2).
    3. Has a documented clinical diagnosis of asthma as defined by ATS (ie, “a disease characterized by increased responsiveness of the trachea and bronchi to various stimuli and manifested by widespread narrowing of the airway that changes in severity either spontaneously or as a result of therapy”) for at least 6 months prior to Visit 2 that has required daily ICS therapy in the low dose range or daily therapy
    with a leukotriene receptor antagonist (LTRA) as monotherapy for at least 30 days prior to Visit 2.
    4. Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last dose of inhaled SABA of greater than or equal to 70% and less than or equal to 95% of predicted normal. Polgar predicted normal standards will be used for all patients.
    5. Demonstrated reversibility of FEV1 of ≥12% from pre-albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol. (Albuterol pMDI, 90 μg per inhalation, 4 actuations, with or without a spacer, or up to 2.5 mg of nebulized albuterol/salbutamol), A documented history of reversibility of FEV1 ≥12% after inhalation of a short acting β2-agonist within 12 months prior to Visit 2 is acceptable. If the patient does not have documented historical reversibility, reversibility testing must be done at Visit 2. A maximum of 2 attempts at reversibility will be allowed: if the patient fails to demonstrate reversibility of FEV1 of ≥12% at Visit 2 and fulfills all other inclusion/exclusion criteria, the patient may return for repeat reversibility testing between 5-14 days after Visit 2 (see Section 3.1.2). No other Visit 2 procedures will need to be performed at the repeat reversibility testing visit. Until the retesting visit, patients must remain on their maintenance ICS or LTRA dose and avoid any excluded medications. If the patient does NOT meet reversibility criterion on repeat testing, he/she will be considered a screen failure. No additional rescreen for reversibility will be allowed.
    6. Has required and received treatment with a consistent daily dose of ICS or leukotriene antagonist within the corresponding dosage range listed below for at
    least 30 days prior to Visit 2:
     Beclomethasone dipropionate hydrofluoroalkane (HFA) pMDI: 80-160 μg/day
     Beclomethasone dry powder inhaler (DPI): 200-500 μg/day
     Budesonide DPI: 180-400 μg/day
     Budesonide (nebulized): 500 μg/day
     Flunisolide: 500-750 μg/day
     Flunisolide HFA: 160 μg/day
     Fluticasone HFA pMDI: 88-176 μg/day
     Fluticasone DPI: 100-200 μg/day
     Triamcinolone acetonide: 300-600 μg/day
     Ciclesonide: 80-160 μg/day
     Mometasone: 110 μg/day (US); 100 μg/day (non-US)
    Montelukast: 5 mg once daily
    Zafirlukast: 10 mg twice daily (approved only for children 7 years and older)
    Note: Non-steroidal asthma controller medications (eg, leukotriene modifiers, mast cell stabilizers, LABAs, xanthines) should not have been used in combination with any of the above for treatment of asthma for 30 days prior to Visit 2. Patients
    should not have required combination controller asthma therapy for 30 days prior to Visit 2.
    7. If receiving immunotherapy, shots must have been on a stable maintenance regimen for at least 6 weeks prior to Visit 2 and was expected to remain on immunotherapy throughout the study.
    Note: Patients who were classified as screen failures prior to the implementation of protocol amendment 4 for not meeting one or more of inclusion criteria 2, 3, 4, 5, 6, or 7 or meeting exclusion criteria may be rescreened for study inclusion. Each patient
    eligible to be rescreened can be rescreened a maximum of one time. However, if a patient was rescreened under protocol amendment 3 and was a rescreening failure, he/she is NOT eligible to be rescreened again under amendment 4.

    Note: Patients who entered run-in and did not meet randomization criteria prior to the implementation of protocol amendment 4 are NOT eligible to be rescreened.
    E.4Principal exclusion criteria
    1. Has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma related condition during the 6 months prior to Visit 2.
    2. Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within 60 days prior to Visit 2.
    3. Has 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 results of the study, or the patient’s ability to participate in the study.
    4. Has a known or suspected hypersensitivity to albuterol/salbutamol or budesonide and/or their excipients.
    5. Has participated in another investigational drug study during the 30 days prior to Visit 2.
    6. Has participated in a prior SYMBICORT® clinical study during the 12 months prior to Visit 2.
    7. Is receiving treatment with a beta-blocker (including eye drops).
    8. Has used a LABA within 30 days prior to Visit 2.
    9. Has used inhaled corticosteroids in combination with other non-steroidal asthma controller medications (eg, leukotriene modifiers, mast cell stabilizers, 5 lipoxygenase inhibitors [5-LOIs]) within 30 days prior to Visit 2.
    10. Has used omalizumab (XOLAIR®, Genentech/Novartis) or any other monoclonal or polyclonal antibody therapy 6 months prior to Visit 2.
    11. Has any clinically relevant abnormal findings in physical examination or vital signs at Visit 2, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
    12. Has a planned hospitalization at any time during the study.
    13. Positive pregnancy test at any time during study.

    Patients who were classified as screen failures prior to the implementation of protocol amendment 4 for not meeting exclusion criteria may be rescreened one time for study
    inclusion. However, if a patient was rescreened under protocol amendment 3 and was a rescreening failure, he/she is NOT eligible to be rescreened again under amendment 4.
    Note: Patients who entered run-in and did not meet randomization criteria prior to the implementation of protocol amendment 4 are NOT eligible to be rescreened.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be morning peak expiratory flow (PEF), collected in a daily diary via electronic patient reported outcome (ePRO).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily
    E.5.2Secondary end point(s)
    The key secondary efficacy variable will be in-clinic morning FEV1. Other secondary efficacy variables include FVC, FEF 25-75, evening PEF, nighttime and daytime asthma symptom scores, nighttime awakenings due to asthma symptoms, and daytime and nighttime reliever medication use. Morning and evening eFEV1 will be exploratory variables.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In-clinic morning FEV1 will be measured at Visits 2-9 (pre-dose morning clinic FEV1, measured at least 6 hours after the last dose of inhaled SABA within a range of 70% to 95% of predicted normal).
    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) 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.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hungary
    Latvia
    Poland
    South Africa
    United States
    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
    The last visit of the last patient undergoing the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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 Yes
    F.1.1Number of subjects for this age range: 290
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 290
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state68
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 290
    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)
    Subjects will resume appropriate asthma therapy and follow-up with their asthma physician
    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 Decision2010-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-05
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