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    Summary
    EudraCT Number:2009-017267-41
    Sponsor's Protocol Code Number:CQAV680A2201E1
    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:2010-03-09
    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 number2009-017267-41
    A.3Full title of the trial
    A randomized, double-blind, parallel group study to compare the pharmacodynamics/efficacy, safety and pharmacokinetics of QAV680 versus placebo in patients with moderate persistent asthma
    A.4.1Sponsor's protocol code numberCQAV680A2201E1
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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.3.2Product code QAV680
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeQAV680
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 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
    Moderate 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
    • To assess the efficacy as measured by trough FEV1 of a 28 day administration of QAV680 500mg q.i.d compared to placebo in patients with moderate persistent asthma.
    • To assess the safety of a 28 day administration of QAV680 500mg q.i.d compared to placebo in patients with moderate persistent asthma.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy as measured by various measures of FEV1 following 28 days of dosing (see protocol for details)
    • To assess the pharmacodynamic effect as measured by eNO of a 28 day administration of QAV680 500mg q.i.d compared to placebo
    • To assess the pharmacokinetics of multiple doses of QAV680 in patients with moderate asthma.
    • To assess the effect of QAV680 on total serum IgE after 28 days of treatment.
    • To assess any change in morning and evening PEFR as recorded by the PIKO meters longitudinally over 28 days of treatment.
    • To assess the effect of QAV680 on asthma control using weekly Asthma Control
    Questionnaire (ACQ) scores over 28 days of treatment.
    • To assess the extent of inhaled salbutamol use as rescue medication over 28 days of treatment.

    Exploratory objective:
    • To assess if post bronchodilator FEV1 measurements demonstrate any potential additive effects on top of the bronchodilator response compared to Baseline.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Part of the same protocol (exporatory objective) but separate consent :
    • To investigate exploratory pharmacogenetics including how pharmacogenetics of CRTh2 SNPs affects drug response to QAV680 in patients who agree to participate in exploratory biomarker evaluation.
    E.3Principal inclusion criteria
    1. Healthy male and female asthma patients 18 to 65 years of age included.

    2. Patients with atopic moderate persistent asthma, diagnosed according to GINA
    guidelines 2008 (see protocol for full details)
    • atopic as confirmed by a positive skin prick test at screening to allergen
    • gradually tapered down on inhaled steroids for at least 28 days
    or washed off any other asthma medication before randomization. Patients may be allowed to enter the study on a stable fraction of the original dose of steroids if they meet all other inclusion criteria. Use of short-acting β2-agonists is permissible as rescue medication.
    • FEV1 of ≥ 60% and ≤ 90% of the predicted normal value at Baseline after the placebo run-in period are completed
    • increase of ≥12% AND 200mL in FEV1 over pre-bronchodilator value within 30 minutes after inhaling 400μg of Salbutamol MDI (or equivalent dose): reversibility
    • symptomatic everyday at Baseline (after steroid and/or LABA Washout)

    3. Women must be post menopausal or surgically sterilized at the time of participation (see protocol for full details).

    4. Male patients must be using a two acceptable methods of contraception, (e.g.,
    spermicidal gel plus condom) for the entire duration of the study, up to the Study
    Completion visit, and refrain from fathering a child in the three months following the
    last study drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.

    5. Patients must weigh at least 45 kg to participate in the study, and must have a body mass index (BMI) of >20 kg/m2.

    6. Able to communicate well with the Investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    E.4Principal exclusion criteria
    1. Pregnant or lactating women.
    2. Smokers (history of smoking in previous 6 months or more than 10 pack years)
    3. Use of any prescription drugs, herbal supplements, within 28 days prior to initial
    dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins
    included) within 14 days prior to initial dosing other than short acting inhaled beta-agonists and paracetamol for the treatment of minor ailments e.g. headache from 48hr before the first dose until the end of study visit is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF.
    4. Participation in any clinical investigation within 28 days prior to initial dosing, or
    within 10 times the corresponding half-life of the drug taken whichever is longer.
    5. Donation or loss of 400ml or more of blood within 56 days prior to initial dosing, or
    longer if required by local regulation. Haemoglobin levels below normal range at
    screening.
    6. Significant illness within 14 days prior to initial dosing.
    7. A past medical history of clinically significant ECG abnormalities, or recent history of
    autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
    8. History of life-threatening asthma, defined as an asthma episode that required
    intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. History of asthma exacerbation in the past 6 months that required
    hospitalization or emergency unit visit.
    9. Use of a biologic (e.g., monoclonal antibodies) agent or oral corticosteroids for the
    treatment of asthma in the past 4 months.
    10. Any disease or illness, other than asthma, that may require the use of systemic
    corticosteroids during the study period.
    11. Any occupational exposure to allergens/ irritants that may have a potential to worsen the asthma symptoms during the study.
    12. Respiratory tract infection and/or exacerbation of asthma within 28 days prior to the first dose of study medication. Patients with other serious underlying diseases (i.e. tuberculosis, bronchiectasis, pulmonary fibrosis, pulmonary hypertension, emphysema, chronic bronchitis, α-1-antitrypsin deficiency).
    ---REFER TO STUDY PROTOCOL FOR FULL LIST OF EXCLUSION CRITERIA---
    E.5 End points
    E.5.1Primary end point(s)
    trough FEV1 of a 28 day administration of QAV680 500mg q.i.d compared to placebo
    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 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=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 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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 88
    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)
    please refer to the protocol
    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 Decision2010-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-02
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