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    Summary
    EudraCT Number:2014-005306-37
    Sponsor's Protocol Code Number:D3741C00003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-005306-37
    A.3Full title of the trial
    A randomized, double-blind, multiple dosing (14 days), placebo-controlled, incomplete block crossover, multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once daily by inhalation, in patients with mild to moderate asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multiple dosing (14 days) crossover, multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once daily by inhalation, in patients with mild to moderate asthma
    A.4.1Sponsor's protocol code numberD3741C00003
    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.1.3.4Country
    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 Centre
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    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 hard capsule 29 - 450 µg
    D.3.2Product code AZD7594 inhalation powder hard capsule 29 - 450 µg
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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.3.9.2Current sponsor codeAZD7594
    D.3.9.3Other descriptive nameAZ13189620
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number29 to 450
    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 placeboInhalation powder, hard capsule
    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
    Patients with mild to moderate asthma
    E.1.1.1Medical condition in easily understood language
    Patients with mild to moderate 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 18.1
    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 is to investigate the efficacy of AZD7594 as measured by change in trough forced expiratory volume in 1 second (FEV1) from baseline, as compared to placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    To investigate the effect of AZD7594 on patient-reported outcomes of Asthma Control Questionnaire (ACQ-5), daily symptoms, nighttime awakenings, use of daily rescue medication and morning peak expiratory flow (mPEF) and evening peak expiratory flow (ePEF)
    • To investigate the effect of AZD7594 on airway inflammation and hyper-reactivity, as measured by fractional exhaled nitric oxide (FeNO)
    • To investigate the pharmacokinetic (PK) profile of AZD7594 in patients with mild to moderate asthma
    • To investigate cortisol suppression from AZD7594, as measured by 24-hour plasma cortisol level
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women 18 to 75 years of age, inclusive
    • Patients need to be non-smokers or ex-smokers (quit ≥ 6 months before the Visit 1) with total smoking history of <10 pack years.
    • Documented clinical diagnosis of asthma for ≥ 6 months before the Visit 1
    • Patients on low-dose inhaled corticosteroids (ICS) (equivalent of budesonide ≤ 400 μg per day) or low-dose ICS/long-acting β-2 agonist (LABA), or not on any inhaled steroids, or patients on montelukast
    • Patients should be controlled on low dose budesonide during the first 14 ± 2 days of Run-in Part 1, i.e., they need to have ACQ-5of ≤ 1.5 at Visit 2.
    • Prebronchodilator FEV1 at Visit 3 should be between 40% and 90% of predicted (mean of 2 predose measurements taken 30 minutes apart).
    E.4Principal exclusion criteria
    • Known or suspected hypersensitivity to the IMPs or excipients, including lactose
    • Systemic steroid use in the 6 weeks before Visit 1
    • Any active disease other than asthma
    • Patients on medium to high-dose ICS (equivalent of budesonide > 400 μg per day) or on inhaled anticholinergic combination within the 6 weeks prior to Visit 1
    • Compliance with the eDiary of at least 80% of the days is expected in both Run-in and Treatment Periods. Patients with < 80% eDiary compliance during Run-in Periods would not be randomized
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Change from baseline in morning trough FEV1 on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of IMP on Day 14

    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy:
    In each period: before the first dose and in the morning of Day 15

    E.5.2Secondary end point(s)
    Efficacy:
    • Change from baseline in FeNO on Day 8
    • Change from baseline in FeNO on Day 15
    • Change from baseline in morning trough FEV1 on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after the dose of IMP on Day 7)
    • Change from baseline in morning trough forced vital capacity (FVC) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after the dose of IMP on Day 14)
    • Change from baseline in morning trough FVC on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after the dose of IMP on Day 7)
    • Change from baseline in mPEF before administration over the Treatment Period
    • Change from baseline in ePEF over the Treatment Period
    • Change from baseline in average daily use of rescue salbutamol over the Treatment Period
    • Change from baseline in ACQ-5 on Day 15
    • Change from baseline in ACQ-5 on Day 8
    • Change from baseline in nighttime awakenings over the Treatment Period
    • Change from baseline in daily symptom score over the Treatment Period
    • Change from baseline in asthma control days over the Treatment Period

    Pharmacokinetics (PK, intense PK subgroup):
    • Observed maximum plasma concentration (Cmax, Day 1 only)
    • Area under the plasma concentration-time curve from time zero to 4 hours after administration (AUC[0-4], Day 1 only)
    • Observed maximum plasma concentration at steady state (Cmax,ss, Day 14 only)
    • Area under the plasma concentration-time curve from time zero to 24 hours after administration (AUC[0-24], Day 14 only)
    • Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-last], Days 1 and 14)
    • Time to reach maximum plasma concentration (tmax, Day 1 only)
    • Time to reach maximum plasma concentration at steady state (tmax,ss, Day 14 only)
    • Average plasma concentration during a dosing interval at steady state (Cavg,ss, Day 14 only)
    • Dose-normalized Cmax (Cmax/D)
    • Dose-normalized AUC(0-24) (AUC[0-24]/D)
    • Predose concentration (Cmin)

    Safety
    adverse events (AEs), FEV1, physical examination findings, vital signs, digital electrcardiograms (dECGs) and laboratoryassessments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    in each period: before first dosing, on Day 8, on Day 15, in the morning and evening from Day 1 to Day 14

    Pharmacokinetics (PK, intense PK subgroup):
    On Day 1 in each period, blood samples for PK measurements will be collected before administration and 15 and 30 minutes, and 1, 2 and 4 hours after administration.
    On Day 14 in each period, blood samples for PK measurements will be collected before administration and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 hours after administration.

    Safety:
    Throughout the study
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 No
    E.8.1.6Cross over Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LSLV
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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)
    Patients will resume their previous treatment after the end of the last treatment period.
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-08
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