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    The EU Clinical Trials Register currently displays   39806   clinical trials with a EudraCT protocol, of which   6534   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-001869-33
    Sponsor's Protocol Code Number:D3551C00001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-03-25
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-001869-33
    A.3Full title of the trial
    A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled, Persistent Asthma
    : 6-месечно, рандомизирано, двойно-сляпо, плацебо контролирано, многоцентрово, паралелно-групово фаза II проучване, за оценка на ефикасността, безопасността и поносимостта на 3 различни дози AZD5069 два пъти дневно като допълнително лечение към средна до висока доза инхалаторни кортикостероиди (ИКС) и β2 агонисти с продължително действие (БАПД) при пациенти с неконтролирана персистираща астма, с незадължителен период с продължителност до 6 месеца на удължаване на проучването по избор на пациента за наблюдение на безопасността
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PhII to Evaluate the efficacy, safety and tolerability of AZD5069 in Patients with Uncontrolled Persistant Asthma.
    Фаза II проучване за оценка на ефикасността, безопасността и поносимостта на AZD5069 при пациенти с неконтролирана персистираща астма
    A.3.2Name or abbreviated title of the trial where available
    NIMBUS
    НИМБУС
    A.4.1Sponsor's protocol code numberD3551C00001
    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 AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountrySweden
    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 nameAZD5069
    D.3.2Product code AZD5069
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZD5069
    D.3.9.1CAS number 878385-84-3
    D.3.9.2Current sponsor codeAZD5069
    D.3.9.3Other descriptive nameN-{2-(2,3-Difluorobenzylthio)-6-[(2R,3S)-3,4-dihydroxybut-2-yloxy]pyrimidin-4-yl}azetidine-1-sulfonamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 nameAZD5069
    D.3.2Product code AZD5069
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZD5069
    D.3.9.1CAS number 878385-84-3
    D.3.9.2Current sponsor codeAZD5069
    D.3.9.3Other descriptive nameN-{2-(2,3-Difluorobenzylthio)-6-[(2R,3S)-3,4-dihydroxybut-2-yloxy]pyrimidin-4-yl}azetidine-1-sulfonamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule, hard
    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
    Астма
    E.1.1.1Medical condition in easily understood language
    Asthma
    Астма
    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 16.0
    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
    To determine the efficacy of 3 different doses of AZD5069 compared with placebo on the rate of severe asthma exacerbations over 6 months in adults with uncontrolled persistent asthma, despite treatment with medium to high dose inhaled corticosteroids (≥fluticasone 500 µg or the equivalent daily) and long acting β2 agonists.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of AZD5069 compared with placebo on:
    1. the rate and total number of days of asthma-specific hospital admissions/Intensive Care Unit admissions
    2. the total number of days on oral corticosteroids due to a worsening of asthma symptoms
    3. pulmonary function
    4. asthma symptoms, use of rescue medication, and asthma control derived from the eDiary
    5. asthma control using the Asthma Control Questionnaire (5-item Version) and the health-related quality of life using the Asthma Quality of Life Questionnaire (Standardised Version)
    6.To describe the pharmacokinetics of AZD5069
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method during the study.
    2. Diagnosis of asthma for at least 12 months (GINA 2011)
    3. Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
    4. Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment
    5. Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)
    E.4Principal exclusion criteria
    1. Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results
    2. Patients with recurrent, latent, or chronic infections
    3. Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
    4. Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
    5. Current smoker or smoking history of more than 20 pack years
    E.5 End points
    E.5.1Primary end point(s)
    Rate of severe asthma exacerbations during 6 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of treatment up to 6 months
    E.5.2Secondary end point(s)
    Rate of asthma-specific hospital admission/Intensive Care Unit admissions during 6 months.
    Total number of days of asthma-specific hospital admission/Intensive Care Unit admissions.
    Total number of days on oral corticosteroids, due to a worsening of asthma symptoms.
    Change from baseline to 2 weeks measurement of pre-bronchodilator FEV1
    Change from baseline to 1 month measurement of pre-bronchodilator FEV1
    Change from baseline to 2 months measurement of pre-bronchodilator FEV1
    Change from baseline to 3 months measurement of pre-bronchodilator FEV1
    Change from baseline to 4 months measurement of pre-bronchodilator FEV1
    Change from baseline to 6 months measurement of pre-bronchodilator FEV1
    Change from baseline to 2 weeks measurement of post-bronchodilator FEV1
    E.5.2.1Timepoint(s) of evaluation of this end point
    From start of treatment up to 6 months
    From start of treatment up to 6 months
    From start of treatment up to 6 months
    Baseline (Day 0) and 2 weeks after Day 0
    Baseline (Day 0) and 1 month after Day 0
    Baseline (Day 0) and 2 months after Day 0
    Baseline (Day 0) and 3 months after Day 0
    Baseline (Day 0) and 4 months after Day 0
    Baseline (Day 0) and 6 months after Day 0
    Baseline (Day 0) and 2 weeks after Day 0
    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 Yes
    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 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 trial4
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    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
    Bulgaria
    Canada
    Colombia
    Czech Republic
    Germany
    Hungary
    Mexico
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    LSLV
    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 months5
    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 months5
    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.1.2.1Number of subjects for this age range: 508
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 339
    F.4.2.2In the whole clinical trial 564
    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)
    Standard of care
    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 Decision2012-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-06-23
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