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    Summary
    EudraCT Number:2019-001259-37
    Sponsor's Protocol Code Number:D3741C00012
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-06-26
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-001259-37
    A.3Full title of the trial
    An Open-Label, Multi-Centre, Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of 2-Week Treatment with Inhaled AZD7594 in Adolescents (12 to 17 years) with Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate how the drug AZD7594 is absorbed in the blood stream, how safe and tolerable it is when administered by DPI once daily via inhalation over two weeks of treatment in adolescent patients with asthma.
    A.3.2Name or abbreviated title of the trial where available
    AMBER
    A.4.1Sponsor's protocol code numberD3741C00012
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/402/2019
    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 code19803
    B.5.3.4CountryUnited States
    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 nameAZD7594 inhalation powder, SD3FL inhaler
    D.3.2Product code AZD7594
    D.3.4Pharmaceutical form Inhalation powder
    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 INNAZD7594
    D.3.9.1CAS number 1196509-60-0
    D.3.9.2Current sponsor codeAZD7594
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number396
    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 (an illness that causes breathing difficulty) that is not fully controlled, so that episodes of breathing difficulty are still occurring despite the use of other available treatments.
    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
    To assess the PK profile of AZD7594 at steady state following daily inhalations (360ug delivered dose) for 2 weeks in adolescent patients with asthma
    E.2.2Secondary objectives of the trial
    To evaluate the PD (plasma cortisol, FEV1, ACQ 5) of AZD7594 following daily inhalations for 2 weeks in adolescent patients with asthma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent prior to any study-specific procedures from patient’sparents/legal guardians is required and signed and dated informed assent from the patient.
    2. Patient (male or female) must be 12 to 17 years of age inclusive, at the time of signing the informed consent/assent.
    3. A minimum of 6-month documented history of asthma treated (daily or intermittently) for
    at least 3 months before screening (Visit 1) with either low dose ICS monotherapy or
    LTRA monotherapy. The patient must have used the monotherapy at least once in the
    3 months prior to screening (Visit 1).
    4. Pre-bronchodilator FEV1 ≥70% of the predicted normal value at screening (Visit 1)
    5. An ACQ-5 (Asthma Control Questionnaire) score <1.5 at screening (Visit 1).
    6. Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products)
    for >6 months prior to screening.
    7. Body mass index (BMI) above the 5th percentile for the patient’s age and gender and a
    minimum weight of 30 kg at screening (Visit 1).
    8. Negative pregnancy test (urine or serum) for post-menarcheal female patients at screening
    (Visit 1). Post-menarcheal female patients must be willing to use a highly effective method of
    contraception which results in a low failure rate (ie, less than 1% per year). Sexual
    abstinence will be accepted as an effective method of contraception, provided a
    discussion occurred between the subject and investigator to confirm this lifestyle.
    9.Negative pregnancy test (urine or serum) for post-menarcheal female patients at baseline
    (Visit 4).
    E.4Principal exclusion criteria
    1. Any clinically significant disease or disorder (eg, cardiovascular, pulmonary other than
    asthma, gastrointestinal, liver, renal, neurological, musculoskeletal including bone
    fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric,
    major physical impairment, severe obesity including weight-related health problems)
    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 patient’s ability to
    participate in the study.
    2. Any clinically relevant abnormal findings in physical examination, clinical chemistry,
    haematology, urinalysis, vital signs, at screening (Visit 1), which, in the opinion of the
    Investigator, may put the patient at risk because of his/her participation in the study.
    3. Prolonged QT interval corrected using Fridericia’s formula (QTcF) ≥440 msec based on
    ECG at screening (Visit 1) or pre-dose at Visit 4, or family history of long QT syndrome.
    4. Prolonged PR interval (>180 msec for ≤16-year-old patients and >200 msec for
    >16-year-old patients) at screening (Visit 1) or pre-dose at Visit 4.
    5. Heart rate <50 beats per minute (bpm) or >110 bpm.
    6. History of or current alcohol or drug abuse (including marijuana), as judged by the
    Investigator.
    7 Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus
    (HCV) antibody or human immunodeficiency virus (HIV) at screening (Visit 1).
    8 Hospitalisation due to asthma exacerbation or asthma exacerbation within 1 month prior
    to screening (Visit 1).
    9 Lower respiratory tract infection within 1 month prior to screening (Visit 1).
    Prior/concomitant therapy
    10 Patient who, in the opinion of the Investigator, is unable to abstain from protocol-defined
    prohibited medications during the study.
    Prior/concurrent clinical study experience
    11 Participation in another clinical study with an investigational drug administered in the last
    3 months before Visit 1, or participation in a method development study (no drug)
    1 month prior to Visit 1.
    Note: Participation is identified as the completion of a treatment-related visit.
    12 A definite or suspected personal history of intolerance or hypersensitivity to drugs and/or
    their excipients, judged to be clinically relevant by the Investigator.
    Other exclusions
    13 Inability to perform the required spirometry assessments, to use the AZD7594 inhaler or
    the SABA inhaler, or to undergo blood sampling.
    14 Parent/legal guardian involvement in the planning and/or conduct of the study (applies to
    both AstraZeneca staff and/or staff at the study site).
    15 Judgement by the Investigator that the patient should not participate in the study if the
    patient is unlikely to comply with study procedures, restrictions and requirements.
    16 Previous enrolment in the present study.
    17 For post-menarcheal female patients only – currently pregnant, breastfeeding, or planning
    to become pregnant during the study.

    After the washout period, patients are eligible to enter the treatment period if none of the
    following exclusion criteria apply:
    1 An ACQ-5 score ≥3 at Visit 4.
    2 SABA use of ≥12 puffs/day for ≥3 consecutive days during the washout period.
    Clinical Study Protocol - 3.0 AstraZeneca
    AZD7594 - D3741C00012
    CONFIDENTIAL AND PROPRIETARY 31 of 92
    3 An asthma exacerbation that required treatment with ICSs or systemic steroids during the
    washout period.
    4 A <70% compliance in completing asthma symptom score during the last 7 days of the
    washout period (ie, <5 out of 7 days with both morning and evening assessments
    completed).
    E.5 End points
    E.5.1Primary end point(s)
    To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    AZD7594 PK parameters at steady state (Day 15, pre-dose and 15 min, 30 min,2, 4, 6, 8, 12 h
    post-dose) to assess systemic exposure and oral clearance: Cmax,ss, Cmin,ss, Ctrough, tmax,ss, AUCĪ„, AUC0-12, and CLss/F.
    E.5.2Secondary end point(s)
    Pharmacodynamic (PD) endpoint:
    Evaluate plasma cortisol, FEV1 and ACQ-5 of AZD7594 following daily inhalations for 2 weeks.

    Safety endpoint:
    To evaluate the tolerability and safety of inhaled AZD7594.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PD endpoint timepoint:
    Relative change from baseline in plasma cortisol AUEC0-12 on Day 15.
    Change from baseline in morning trough FEV1 on Day 15.
    Change from baseline in ACQ-5 on Day 15.

    Safety endpoint timepoint:
    Incidence of AEs, vital signs, clinical laboratory parameters, physical examination, and ECG.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmaco kinetics
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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’. For this study, the last visit corresponds to the Follow-up Contact (Visit 7)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months7
    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: 24
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 24
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 24
    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)
    There are no plans to provide study treatment after termination of the study. Patients can return to their usual medication after completion of the study
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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