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    The EU Clinical Trials Register currently displays   37236   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-005084-32
    Sponsor's Protocol Code Number:D6230C00001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-005084-32
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel group, multi-centre Phase IIa study in asthma patients comparing the efficacy and safety of once daily inhaled Interferon beta-1a to placebo, administered for 14 days after the onset of symptoms of an upper respiratory tract infection for the prevention of severe exacerbations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate if inhaled Interferon beta-1a is safe, and could prevent or reduce the severity of asthma attacks when administered to asthma patients at the onset of a virus affecting their airways (e.g. common cold or influenza)
    A.3.2Name or abbreviated title of the trial where available
    INEXAS
    A.4.1Sponsor's protocol code numberD6230C00001
    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 Centre
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.centre@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 nameInterferon beta-1a Nebuliser solution 48 μg/mL
    D.3.2Product code Interferon beta-1a Nebuliser solution 48 μg/mL
    D.3.4Pharmaceutical form Nebuliser solution
    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 INNInterferon beta-1a
    D.3.9.1CAS number 145258-61-3
    D.3.9.2Current sponsor codeInterferon beta-1a
    D.3.9.3Other descriptive nameIFN beta-1a
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48 to 1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboNebulisation solution
    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
    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.1.2 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
    To evaluate the efficacy of inhaled Interferon beta-1a compared to placebo in preventing severe exacerbations during the 14 days of treatment following onset of an upper respiratory tract infection in asthmatic patients, on top of their regular asthma maintenance treatment.
    E.2.2Secondary objectives of the trial
    To evaluate the preventive or attenuating effect of inhaled Interferon beta-1a compared to placebo on deterioration of secondary efficacy endpoints during and after upper respiratory tract infection. Analysed variables will include:
    - Occurrence of severe exacerbations with onset during day 1-30 after start of treatment
    - Occurrence of moderate exacerbations with onset during day 1-30 after start of treatment
    - Time to severe exacerbation
    - Time to moderate exacerbation
    - Change from treatment baseline in Patient reported outcomes
    - (a) Asthma control as measured by ACQ-6
    - (b) Day-time and night-time asthma symptom score and night-time awakenings as determined by area under the curve (AUC) over day 1-14
    - (c) Health-related quality of life as measured by AQLQ(S)
    - Day-time and night-time reliever medication use as determined by AUC over day 1-14 as change from the treatment baseline level
    - Lung function, ie morning and evening PEF and FEV1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study patients should fulfil the following criteria:
    1.Provision of signed and dated written informed consent prior to any study specific procedures
    2.Male or female aged 18 and above at the time of screening
    3.History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250 μg fluticasone dry powder formulation equivalents total daily dose, as defined in GINA 2014; see CSP App. G) and a second controller medication as recommended in the GINA guidelines (ie, LABA or leukotriene receptor antagonist). The medium or high dose ICS plus LABA can be any combination inhaler or 2 separate inhalers. Patients must have taken ICS (>250 μg fluticasone or the equivalent daily) plus second controller medication for at least 12 months prior to the date the informed consent is obtained, with or without another controller such as OCS, theophylline, tiotropium, or leukotriene receptor antagonists. The maintenance treatment must have been kept at the same or at ahigher level these last months.
    4.Proof of post-bronchodilator reversibility in FEV1 of ≥12% and ≥200 mL (Pellegrino et al 2005) documented within 5 years prior to Visit 1, or proof of a positive response to a methacholine or histamine challenge (a decrease in FEV1 by 20% [PC20] at ≤8 mg/mL) performed according to ATS/ERS guidelines (American Thoracic Society 2000) or proof of positive response to mannitol challenge (a descrease in FEV1 by 15%[PD15] at <=635 mg)(Anderson et al 2009) documented within 5 years prior to Visit 1. If historical documentation is not available, reversibility or proof of a positive response to a methacholine, histamine or mannitol challenge must be demonstrated and documented at Visit 1
    5.Must answer “Yes” to the question “Does a cold or flu make your asthma worse?”
    6.To have had at least two documented severe asthma exacerbations within the last
    24 months that were suspected by the patient to have been caused by a cold or flu and
    To have had at least one documented severe asthma exacerbation within the last
    12 months that was suspected by the patient to have been caused by a cold or flu
    A severe asthma exacerbation is defined as worsening of asthma symptoms and:
    -Use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least three days and/or
    - An unscheduled visit or emergency room visit due to asthma symptoms that requires at least one dose of systemic corticosteroids and/or
    - An in-patient hospitalization due to asthma requiring at least one dose of systemic corticosteroids
    The below defines what is acceptable to document exacerbations in this study
    - Discharge summaries from a hospital, emergency department, or an urgent care facility indicating that a subject was hospitalized/treated with systemic steroids for an asthma exacerbation.
    - Signed and dated notes from a referring physician, including information regarding diagnosis and treatment of an exacerbation with systemic steroids.
    -Patients can provide evidence of prescriptions for systemic steroids used during an exacerbation.
    -A documented conversation between the treating/referral physician or nurse/nurse practitioner certifying that a patient was treated for an exacerbation with steroids at their clinic or under their supervision. The dates (month/year)
    of the exacerbations and verbal confirmation that appropriate prescriptions
    were provided is necessary. This option should be used only if reasonable attempts to procure patient records have been unsuccessful.
    A combination of the above is acceptable to document the two required exacerbations. However, it is necessary for the Investigator to document how they obtained confirmation of the patient’s asthma exacerbations. It is the Investigator’s responsibility to ensure patient eligibility into the clinical study.
    7.Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception
    8.Negative pregnancy test (urine) for female patients of childbearing potential
    9. Motivation (in the Investigator’s opinion) to complete all study visits, the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment including its risks and benefits
    10. Ability to read and write and use the electronic devices, including demonstrating an acceptable techniques when using the ePRO device, home spirometer and the I-neb

    For participation in the optional genetic research:
    10.Provision of signed and dated written informed consent for optional genetic research. If a patient declines to participate in the optional exploratory genetic research there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study
    E.4Principal exclusion criteria
    Patients should not enter if any exclusion criteria are fulfilled:
    1.Involvement in planning and/or conduct of the study(applies to both AZ staff and staff at third party vendors or staff at the study sites)
    2.Previous randomization to treatment in present study
    3.Any condition, including findings in the medical history or in the pre-study assessm. that, in the opinion of the Investigator constitutes a risk or a contraindication for the participation of the pat in the study
    4.Lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis, allergic bronchopulmonary aspergillosis, active tuberculosis). patients with CT or chest X-ray findings indicating bronchiectasis which in the opinion of the Investigator are not clinically significant may be enrolled at the discretion of the Investigator.
    5.Patients with ≥4 severe exacerbations during the last 12 months that the patient suspected were triggered by something else than an upper respiratory tract infection
    6.Current participation in another clinical trial or participation in a clinical trial where the patient has received a dose of a test product (IMP) within 12 weeks prior to
    entry into the study for small molecules and within 12 months prior to entry into the study for biologicals, or 5 times the half-life (whichever is the longest) of the biologic or small molecule IMP.
    7.Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact interpretation of results eg, infections, haematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, including arrhythmias, endocrinological or gastrointestinal disease
    8.Abnormal vital signs, after at least 10 minutes supine rest, defined as any of the following:
    -In patients<60 years old, systolic blood pressure <90mmHG or >=150mmHg
    -In patients >= 60 years old, systolic blood pressure <90 mmHg or ≥160 mmHg
    -Diastolic blood pressure <50 mmHg or ≥100 mmHg
    -HR <45 or >95 beats per minute
    9.Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the Investigator,
    10.Prolonged QTcF >450 ms (for both gender) or shortened QTcF <340 ms or family history of long QT syndrome
    11.PR(PQ) interval shortening <120ms (PR<120 ms but >110 ms is acceptable if there is no evidence of ventricular pre-excitation).
    12.PR(PQ) interval prolongation (>240ms), intermittent second or third degree AV
    block, or AV dissociation
    13.QRS duration >120ms including persistent or intermittent bundle branch block
    14.Patients with implantable cardiac defibrillator (ICD) or a permanent pacemaker and patients with symptomatic ventricular and / or atrial tachyarrhythmias
    15.Patients with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society (CSS) class II or a myocardial infarction or stroke within 6 months
    16.History of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) class II
    17.History of hypersensitivity to natural or recombinant Interferon beta-1a or to any of the drug preparation excipients
    18.Received any marketed biologic agent (eg, omalizumab) within 12 months or
    5 times the half-life (whichever is the longer) of the agent prior to enrolment
    19.Significant history of depressive disorder or suicidal ideation. Specifically; individuals with current severe depression (ie, a low mood, which pervades all aspects of life and an inability to experience pleasure in activities that formerly were enjoyed); individuals with a past history of depression that required
    hospitalization or referral to psychiatric services in the past 5 years; individuals who
    currently feel suicidal or have attempted suicide in the past
    20.History of epilepsy or seizures after age 5 years, other than febrile childhood seizure(s)
    21.History of drug or alcohol abuse within 12 months prior to screening enrolment
    22.Patients who have hepatic serum enzyme levels ≥2.5 times the normal range
    23.Positive test for serum hepatitis B surface antigen, hepatitis C antibody, or HIV
    24.Patients with a smoking history of ≥20 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year)
    25.Female who is breast-feeding, pregnant (verified by urine dipstick pregnancy test)
    or intends to become pregnant during the study
    26.Patients who are unable to demonstrate an acceptable spirometry technique
    27.Patients that have previously been included in studies evaluating the investigational medicinal product
    For participation in the optional genetic research. Any of the following is regarded as a criterion for exclusion from the genetic research:
    28.Previous bone marrow transplant
    29.Non-leukocyte depleted whole blood transfusion within 120 days of the date of the
    PGx sample collection
    E.5 End points
    E.5.1Primary end point(s)
    Number of severe exacerbations (during 14 days of treatment)
    Duration of severe exacerbation

    E.5.1.1Timepoint(s) of evaluation of this end point
    During the 14 days of treatment
    E.5.2Secondary end point(s)
    Number of moderate exacerbations (during 14 days of treatment)
    Number of severe exacerbations (during day 1-30 after start of treatment)
    Number of moderate exacerbations (during day 1-30 after start of treatment)
    Time to sever exacerbation
    Time to exacerbation (moderate or severee)

    Change from treatment baseline in Patient reported outcomes in the following variables:
    - Asthma control as measured by ACQ-6
    - Day-time and night-time asthma symptom score and night-time awakenings as determined by area under the curve (AUC) over day 1-14
    - Health-related quality of life as measured by AQLQ(S)

    Day-time and night-time reliever medication use as determined by AUC over day 1-14 as change from the treatment baseline level

    Lung function ie, PEF, FEV1
    Morning and evening peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) measured daily at home, as determined by AUC over day 1-14 as change from the baseline level
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the 14 days of treatment and for some up to 30 days after start of treatment
    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 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) 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 trial2
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Argentina
    Australia
    Colombia
    France
    Korea, Democratic People's Republic of
    Spain
    United Kingdom
    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
    LVLS
    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 months7
    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 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 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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 220
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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