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    Summary
    EudraCT Number:2010-020407-73
    Sponsor's Protocol Code Number:D9830C00008
    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:2010-06-17
    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 number2010-020407-73
    A.3Full title of the trial
    A double-blind, placebo-controlled, randomised, parallel-group, phase-II, multi-centre study to assess the efficacy, safety and tolerability of 4 twice daily doses and 2 once daily doses of AZD1981 given as tablets during 12 weeks in asthmatic patients treated with inhaled corticosteroids and long-acting-β2-agonists.
    A.4.1Sponsor's protocol code numberD9830C00008
    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.3.2Product code AZD1981
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeAZD1981
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 100
    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 pMDI
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca LP (US licence holder, product not registered in the EU)
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 pMDI
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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.3.9.3Other descriptive namebudesonide
    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.3.9.3Other 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 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 placeboTablet
    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
    asthma
    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 is to evaluate efficacy of AZD1981 compared with placebo in asthmatic patients treated with inhaled corticosteroids (ICSs) and long-acting β2- agonists (LABAs).
    E.2.2Secondary objectives of the trial
    The secondary objectives are: • To investigate the dose response relationship of AZD1981 in asthmatic patients treated with ICS and LABA. • To compare once and twice daily administration of AZD1981 in asthmatic patients treated with ICS and LABA. Safety objective: • To investigate the safety and tolerability of AZD1981 in asthmatic patients treated with ICS and LABA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the run-in study period patients should fulfil the following criteria: 1. Provision of signed and dated informed consent prior to any study specific procedures. For patients under-age, signed and dated informed consent from both the patient´s parent/legal guardian is required.
    2. Outpatients, men or women aged 18 years or above. Women must be either surgically sterilised or post-menopausal or use a highly effective method of birth control, ie, double barrier method contraception (condom and diaphragm with spermatocide or copper banded Intra Uterine Devices).
    3. A minimum of 6 months documented history of asthma according to the ATS definition (1987).
    4. Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2.
    5. Stable dose of ICS and LABA for the last 4 weeks prior to Visit 2. The prescribed dose of ICS and LABA must have been constant. This prescribed daily dose of ICS should be equal to or less than 500 μg of budesonide, fluticasone, ciclesonide, mometasone, HFA beclomethasone or 1000 μg CFC beclomethasone dipropionate, or other in equivalent dose.
    6. Pre-bronchodilator FEV1 of 40% to 85% of predicted normal (PN) according to European Respiratory Society (ERS) guidelines.
    7. Reversibility of airway obstruction according to reversibility test performed at Visit 2, defined as an increase in FEV1 ≥12% relative baseline after inhalation of up to 400 μg salbutamol, 360 μg albuterol or 1 mg terbutaline sulphate. (Reversibility may be repeated once prior to run-in for patients just failing to meet the reversibility criteria at Visit 2, but not later than 7 days after the initial measurement.).
    8. Atopy shown by Phadiatop test.
    9. Non-smokers, defined as not having smoked at more than five occasions within the previous year.
    For inclusion in the pharmacogenetic research, patients must fulfil the following criterion:
    10. Provision of Informed Consent for pharmacogenetic research. If a patient declines to participate in the pharmacogenetic research, there will be no consequence or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this CSP, as long as they consent to participate in the main study.
    Randomisation criteria: For inclusion in the study treatment period the patients must also fulfil the following criteria at Visit 3:
    11. A total ACQ5 score of 1.5 or more.
    12. Pre-bronchodilator FEV1 of 40% to 85% of predicted normal (PN) according to ERS guidelines.
    13. Ability to complete an eDiary correctly. Baseline diary data must be recorded for at least 8 (any 8) of the last 10 days of the run-in period.
    14. Stable dose of Symbicort pMDI and no use of oral GCS during run-in.
    E.4Principal exclusion criteria
    Patients should not enter the study if any of the following exclusion criteria are fulfilled
    1. Respiratory infection significantly affecting the asthma, as judged by the investigator within 2 weeks prior to Visit 2.
    2. Any significant disease or disorder (eg, cardiovascular, pulmonary (other than asthma), gastrointestinal, hepatic, renal, neurological, musculosceletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, either put the patient at risk because of participating in the study or may influence the results of the study, or the patients ability to participate in the study.
    3. Any clinically relevant abnormal findings in clinical chemistry, haematology, urinalysis, physical examination, pulse, blood pressure or ECG at Visit 2, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
    4. Having a smoking history of more than 10 pack years (1 pack year = 20 cigarettes smoked per day for one year).
    5. Intake of oral, rectal or parental GCS within 30 days of Visit 2.
    6. Use of any β-blockers including eye drops.
    7. Known or suspected hypersensitivity to study therapy or excipients of the IP.
    8. History of chronic alcohol or drug abuse or any condition associated with poor compliance as judged by the investigator.
    9. Planned blood donation during the study.
    10. Participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 1 month prior to Visit 1
    11. Planned in-patient surgery or hospitalisation during the study period.
    12. Previous randomisation of treatment in the present study.
    13. Involvement in the planning and conduct of the study (applies to both AstraZeneca personnel and/or study personnel at the study site).
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is pre-dose pre-bronchodilator Forced Expiratory Volume in one second (FEV1) measured at the clinic.
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 1120
    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 Decision2010-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-16
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