Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35134   clinical trials with a EudraCT protocol, of which   5741   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-005293-22
    Sponsor's Protocol Code Number:D589GC00003
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-10
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2013-005293-22
    A.3Full title of the trial
    A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group,
    Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI
    80/2.25 ug, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 ug,
    2 Actuations Twice Daily, Compared with Budesonide pMDI 80 ug,
    2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg.
    A.4.1Sponsor's protocol code numberD589GC00003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02091986
    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 organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington, DE
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 236-9933
    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 nameSymbicort HFA pMDI 80/4.5
    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.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    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) 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.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 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 HFA pMDI 80/2.25
    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.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    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) 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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.3.9.4EV Substance CodeSUB05955MIG
    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
    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.1.3Condition 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 demonstrate the efficacy of Symbicort pMDI 80/4.5 μg, 2 actuations twice daily, and Symbicort pMDI 80/2.25 μg, 2 actuations twice daily, compared with budesonide pMDI 80 μg, 2 actuations twice daily, in children ages 6 to <12 years with asthma.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to compare the efficacy of Symbicort pMDI 80/4.5 μg, 2 actuations twice daily, with Symbicort pMDI 80/2.25 μg, 2 actuations twice daily, in children ages 6 to <12 years with asthma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study, patients should fulfill the following criteria at Visit 1:
    1. Provision of a signed and dated (by the parent or legal guardian) written Informed Consent form (and assent form, per Institutional Review Board [IRB]/Ethics Committee [EC] requirements) prior to undergoing any study-related procedures including being asked to withdraw regularly used medications
    2. Be between the ages of 6 and <12 years (not having reached his/her 12th birthday at the time of Visit 1)
    3. Have a documented clinical diagnosis of asthma as defined by the 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.
    4. If receiving immunotherapy injections, a patient must have been on a stable maintenance regimen for at least 6 weeks and be expected to remain on immunotherapy throughout the study.
    5. Require and be prescribed treatment with a consistent daily dose of ICS within the corresponding dosage range listed below for at least 4 weeks prior to Visit 1. If the patient is not under the care of the investigator, documentation of ICS use by pharmacy records or copies of the prescribing health care provider’s records are required to verify ICS use.
    - Budesonide 320 μg to 540 μg/day
    - Beclomethasone HFA: 160 to 320 μg/day
    - Budesonide (nebulized): 1000 μg/day
    - Flunisolide: 1000 to 1250 μg/day
    - Flunisolide HFA: 320 μg/day
    - Flunisolide HFA pMDI: 176 to 352 μg/day
    - Fluticasone DPI: 200 to 400 μg/day
    - Triamcinolone acetonide: 600 to 900 μg/day
    - Ciclesonide: 160 to 320 μg/day
    - Mometasone: 110 to 220 μg/day
    - OR on a fixed combination of ICS and LABA
    Note: Other non-steroidal asthma medications (eg, leukotriene modifiers, mast cell stabilizers) could have been used in combination with any of the above and would not impact a patient’s eligibility. These medications must be discontinued at or before Visit 2. After providing written informed consent for the study, potential patients maintained on a fixed combination of ICS and LABA should be switched
    to a comparable dose of ICS without the addition of LABA at least 48 hours prior to Visit 2. This change will not be considered a change in the dose of maintenance ICS.
    For inclusion in the study, patients should fulfill the following criteria at Visit 2:
    6. Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after the last dose of inhaled LABA of 60% to 100% of predicted normal. Polgar predicted normal standards will be used for all patients. Race correction will be applied as appropriate. If the patient is
    taking a fixed combination of ICS/LABA, the patient is to be placed on a comparable dose of ICS monotherapy, without LABA, at least 48 hours prior to Visit 2.
    7. Demonstrate reversibility of clinic FEV1 of ≥12% from pre- albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol (albuterol/salbutamol pMDI, 90/100 μg per inhalation, 2 to 4 actuations, with or without a spacer, or up to 2.5 mg of nebulized
    albuterol/salbutamol). For patients who fail to demonstrate reversibility at Visit 2, but meet all of the other inclusion criteria and none of the exclusion criteria, the assessment can be repeated once, after Visit 2, but prior to Visit 3.
    8. Demonstrated ability to use any device to be used in the study
    E.4Principal exclusion criteria
    1. Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
    2. Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1
    3. Have any significant disease or disorder (eg, cardiovascular, pulmonary [other than asthma], gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) or other disease or
    condition generally affecting lung function (eg, prematurity, congenital lung anomalies, tracheoesophageal fistula, bronchiectasis, chronic sinusitis) which, in the opinion of the investigator, could place the patient at risk if participating in the study, or could influence the results of the study or the patient's ability to participate in the study
    4. Have participated in another investigational drug study during the 4 weeks prior to Visit 1
    5. Receiving treatment withβ-blocker (including eye drops)
    6. Have taken omalizumab (Xolair®, Genentech/Novartis) or any other monoclonal or polyclonal antibody therapy, for any reason within the 6 months prior to Visit 2
    7. Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide, or formoterol, and/or their excipients and/or have a severe hypersensitivity to milk proteins
    8. Have 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
    9. Have a planned hospitalization at any time during the study
    10. Have a positive pregnancy test at any time during study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable to be analyzed to address the primary and secondary objectives will be the 1-hour post-dose forced expiratory volume in the first second (FEV1) (L) measured in clinic (clinic FEV1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    The secondary efficacy variables to be analyzed to address the primary and secondary objectives will be:
    * Pre-dose clinic FEV1 (L), clinic FVC (L), clinic FEF25-75 (L/s), and clinic PEF
    (L/min)
    * Fifteen-minute post-dose clinic FEV1 (L), clinic FVC (L), clinic FEF25-75 (L/s), and clinic PEF (L/min)
    * One-hour post-dose forced vital capacity (FVC) (L) measured in the clinic (clinic FVC)
    * One-hour post-dose forced expiratory flow between 25% and 75% of the forced vital capacity (FEF25-75) (L/s) measured in the clinic (clinic FEF25-75)
    * One-hour post-dose peak expiratory flow (PEF) (L/min) measured in the clinic (clinic PEF)
    * Morning and evening FEV1 (L) and PEF (L/min) recorded in the electronic diary (eDiary)
    * Nighttime, daytime, and total daily asthma symptom scores recorded in the eDiary
    * Nighttime awakenings due to asthma symptoms requiring reliever use recorded in the eDiary during the single-blind run-in and the double-blind treatment periods
    * Daytime, nighttime, and total daily reliever medication use recorded in the eDiary
    * Paediatric Asthma Quality of Life Questionnaire with Standardised Activities (PAQLQ[S]) scores (overall and each domain)
    * Time to occurrence of first asthma exacerbation
    * Time to discontinuation of investigational product (IP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Mexico
    Panama
    Slovakia
    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 end of the study is defined as "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 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 years1
    E.8.9.2In all countries concerned by the trial months9
    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: 279
    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: 279
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 279
    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)
    At study completion, patients 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 Decision2014-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-15
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA