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    Summary
    EudraCT Number:2007-006545-41
    Sponsor's Protocol Code Number:PPD/2007/AER 001 DPI/2b
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-24
    Trial 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-006545-41
    A.3Full title of the trial
    A PHASE IIB STUDY TO INVESTIGATE THE TREATMENT-SPARING EFFECTS OF
    AEROVANT™ (AER 001 INHALATION POWDER) IN ASTHMA PATIENTS NOT FULLY
    CONTROLLED ON CURRENT THERAPY
    A.3.2Name or abbreviated title of the trial where available
    AEROVANT
    A.4.1Sponsor's protocol code numberPPD/2007/AER 001 DPI/2b
    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 SponsorAerovance, inc
    B.1.3.4CountryUnited States
    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.3.1Product nameAEROVANT
    D.3.2Product code AER 001
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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.3.8INN - Proposed INNPitrakinra
    D.3.9.2Current sponsor codeAER 001
    D.3.9.3Other descriptive nameBAY 169996
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) 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 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 nameAEROVANT
    D.3.2Product code AER 001
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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.3.8INN - Proposed INNPitrakinra
    D.3.9.2Current sponsor codeAER 001
    D.3.9.3Other descriptive nameBAY 169996
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) 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: 3
    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 nameAEROVANT
    D.3.2Product code AER 001
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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.3.8INN - Proposed INNPitrakinra
    D.3.9.2Current sponsor codeAER 001
    D.3.9.3Other descriptive nameBAY 169996
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) 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 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
    moderate persistent to severe persistent asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary: To investigate the effects of AEROVANT™ on the
    incidence of asthma exacerbations in asthmatic patients treated
    initially with moderate-to-high doses of ICS and LABA (in the form
    of combination therapy or as individual therapies in parallel) and not
    fully controlled on current therapy.
    E.2.2Secondary objectives of the trial
    Secondary: To examine the effects of AEROVANT™ on daily and
    in-clinic pulmonary function, time to exacerbation after
    randomization, daily asthma symptom scores, fractional concentration
    of expired nitric oxide (FENO), population pharmacokinetics (PK),
    serum total IgE, and general safety endpoints.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic sub-study in association with study PPD/2007/AER 001 DPI/2b

    The exploratory objective of this study is the following:
    Single nucleotide polymorphism (SNP) analysis of genes associated with IL-4 and IL-13 pathways.
    E.3Principal inclusion criteria
    In order to be eligible for the study each of the following criteria must be satisfied with a
    “YES” answer:
    1) Male or female patient, ≥ 18 years of age with a documented clinical history of
    asthma, has been treated for asthma and, in the opinion of the Investigator, is not
    fully controlled on current asthma therapy.
    2) Patient satisfies, or has satisfied in the past, the GINA definition of moderate
    persistent to severe persistent asthma.
    3) Patient has been maintained on moderate-to-high doses of ICS and LABA in the
    form of combination therapy or as individual agents (equivalent to fluticasone
    ≥ 250 mcg bid and salmeterol ≥ 50 mcg bid for ≥ 4 weeks before Screening
    [Visit 1]).
    4) Patient has experienced an asthma exacerbation at least once in the past 2 years (defined here as use of physician-prescribed oral corticosteroids or asthma requiring treatment increase approximately four times the baseline dose of inhaled corticosteroids or hospitalization for asthma).
    5) Patient has a pre-bronchodilator FEV1 ≥ 50% but ≤ 95% of the predicted value at
    both Screening (Visit 1) and Visit 2.
    6) Patient demonstrates ≥ 12% reversibility (and a ≥ 200 mL difference) from
    prebronchodilator FEV1 within 15 to 30 minutes of receiving up to 4 puffs of a
    short-acting beta-agonist at Screening (Visit 1). Alternatively, the patient has ≥ 10% reversibility from pre-bronchodilator FEV1 plus a documented reversibility of ≥ 12% within the previous 12 months (Documented methacholine or histamine sensitivity (PC20) less than 8 mg/mL is also acceptable evidence of reversible airways disease).
    7) Patient scores ≤ 20 on The Asthma Control Test™ at Screening (Visit 1) and
    Visit 2.
    8) Female patient of childbearing potential or male patient and his female partner are
    practicing adequate and effective forms of contraception and agree to continue for
    the duration of the study (see Section 4.7.2). If female, must have a negative
    urine pregnancy test.
    9) Patient has a pre-study medical history, physical examination, 12-Lead ECG, and
    safety laboratory test results within normal reference ranges or clinically
    acceptable to the Investigator.
    10) Patient is a non-smoker for at least 6 months before Screening (Visit 1) and has a < 10 pack/year history of smoking.
    11) Patient is medically stable for at least 8 weeks before Randomization (Visit 2),
    and the Investigator does not consider study participation to place the patient at
    increased risk of AEs (with the exception of possible asthma exacerbations).
    12) Patient is able and willing to give written informed consent.
    E.4Principal exclusion criteria
    In order to be eligible for this study, each of the following criteria must be satisfied with a “NO” answer:
    1) Patient has a current diagnosis of respiratory disorder other than asthma (e.g.,
    chronic bronchitis, bronchiectasis, emphysema, chronic obstructive pulmonary
    disease [COPD], etc).
    2) Patient has received oral corticosteroid treatment within 8 weeks of
    Randomization (Visit 2) or patient has been intubated for ventilation in the past 5 years.
    3) Patient has used any leukotriene antagonist within 1 week before Screening
    (Visit 1) or anti-IgE medications within 4 weeks of Screening (Visit 1).
    4) Female patient is pregnant, breastfeeding, or not using an adequate method of
    contraception as defined in Section 4.7.2 (of the protocol).
    5) Patient has a clinically relevant history of very severe asthma or other medical history that would preclude steroid reduction or sufficient compliance with the protocol.
    6) Patient uses concomitant medications, including herbal, over-the-counter, or
    prescription medicines that, in the opinion of the Investigator, may affect the
    outcome of study endpoints and/or well-being of the patient.
    7) Patient has a history of alcohol or substance abuse within 2 years of Screening
    (Visit 1).
    8) Patient consumes more than 28 units (male) or 21 units (female) of alcohol a
    week (unit = 1 glass of wine = 1measure of spirits = ½ pint or 8 fluid ounces of
    beer).
    9) Patient cannot communicate reliably with the Investigator or is unlikely to
    cooperate with the requirements of the study.
    10) Patient has previously taken AEROVANT™ or another formulation of AER 001
    (e.g., BAY 16-9996, pitrakinra).
    11) Patient has participated in any clinical trial involving use of an investigational
    drug within 12 weeks of first dose of study drug.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is exacerbation incidence. Exacerbation is defined by any one of the following:
    1. Morning PEF ≥ 30% below baseline for ≥ 2 consecutive days AND
    ≥ 6 additional reliever occasions (1 puff = 1 reliever occasion) in a 24-hour period
    over baseline for ≥ 2 consecutive days, OR
    2. Deterioration of asthma requiring treatment with oral corticosteroids, OR
    3. Deterioration of asthma requiring treatment increase ≥ 4 times the baseline dose
    of inhaled corticosteroids, OR
    4. Deterioration of asthma requiring hospitalization, OR
    5. In the opinion of the Investigator, the patient’s condition is deteriorating
    significantly to the point of considering it an asthma exacerbation.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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.8.3 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 EEA50
    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
    Last visit of last subject
    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 months3
    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 months3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 500
    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 be transfered back onto the routine drug.
    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 Decision2009-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-01
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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