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    Summary
    EudraCT Number:2008-005205-19
    Sponsor's Protocol Code Number:LPA112356
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-10
    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 number2008-005205-19
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, 3-period cross-over study to evaluate the effect of two doses of GSK2190915 on the allergen-induced early asthmatic response in subjects with mild asthma
    A.4.1Sponsor's protocol code numberLPA112356
    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 SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 nameGSK2190915 Oral Solution
    D.3.2Product code GSK2190915
    D.3.4Pharmaceutical form Oral solution
    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 codeGSK2190915
    D.3.9.3Other descriptive nameAM803
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 10
    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 placeboOral solution
    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
    Mild 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 10001705
    E.1.2Term Allergic 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 evaluate the effect of treatment with repeat oral doses of GSK2190915 on the early asthmatic response (EAR) to inhaled allergen in mild asthmatic subjects compared with placebo
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of treatment with repeat oral doses of GSK2190915 on lung
    function as measured by FEV1 on Days 1 and 3 in subjects with mild asthma
    compared with placebo

    • To assess the safety and tolerability of repeat oral doses of GSK2190915 in mild
    asthmatic subjects compared with placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged 18 to 55 years inclusive.
    2. Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
    3. Female subjects must be of non childbearing potential.
    4. Male subjects must agree to use one of the contraception methods listed in
    Section 8.1 of the protocol.
    5. Documented history of bronchial asthma, first diagnosed at least 6 months prior
    to the screening visit and currently being treated only with intermittent short-
    acting beta -agonist therapy by inhalation.
    6. Pre-bronchodilator FEV1 >70% of predicted at screening.
    7. Subjects who are current non-smokers who have not used any tobacco products
    in the 6-month period preceding the screening visit.
    8. Demonstration of a positive wheal and flare reaction (> 3 mm relative to negative
    control) to at least one allergen from a battery of allergens on skin prick testing.
    9. Methacholine challenge PC20 < 8 mg/mL at screening or previous AMP, histamine
    or methacholine challenge that confirms the diagnosis of asthma.
    10. Screening allergen challenge demonstrates that the subject experiences an
    early asthmatic response.
    E.4Principal exclusion criteria
    1. Past or present disease, which as judged by the investigator or medical monitor,
    may affect the outcome of this study.
    2. Clinically significant abnormalities in safety laboratory analysis at screening.
    3. Subject has known history of hypertension or is hypertensive at screening.
    4. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to
    the first dose of study medication.
    5. 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.
    6. Symptomatic with hay fever at screening or predicted to have symptomatic
    hayfever during the time of study.
    7. Administration of oral or injectable steroids within 5 weeks of screening or
    intranasal and/or inhaled steroids within 4 weeks of the screening visit.
    8. Unable to abstain from other medications including non-steroidal anti-
    inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-
    asthma, anti-rhinitis or hay fever medication.
    9. If, after 2 concurrent administrations of saline during the allergen challenge at
    screening the subjects still have a fall in FEV1 of greater than 10%.
    10.The subject has participated in a study with a new molecular entity during the
    previous 3 months or has participated in 4 or more clinical studies in the previous
    12 months prior to the first dosing day.
    11.History of being unable to tolerate or complete methacholine and/or allergen
    challenge tests.
    12.The subject has a screening QTc value of >450msec, PR interval outside the
    range 120 to 220msec or an ECG that is not suitable for QT measurements.
    13.The subject has tested positive for hepatitis C antibody or hepatitis B surface
    antigen.
    14.The subject has tested positive for HIV antibodies.
    15.The subject has a positive pre-study urine cotinine/ breath carbon monoxide test
    or urine drug or urine or breath alcohol screen.
    E.5 End points
    E.5.1Primary end point(s)
    Early Asthmatic Response: Minimum FEV1 absolute change from baseline between 0-2 hours after allergen challenge on Day 3 of each treatment period
    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) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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.8.5The 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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 months6
    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 months6
    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) 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    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 for treatment of subjects after the trial has completed.
    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 Decision2008-11-05
    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 trial2009-07-28
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