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    Summary
    EudraCT Number:2008-002580-13
    Sponsor's Protocol Code Number:LPA111834
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-31
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-002580-13
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, 2-period crossover study to evaluate the effect of treatment with GSK2190915 on the allergen-induced asthmatic response in subjects with mild asthma
    A.4.1Sponsor's protocol code numberLPA111834
    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
    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.3.2Product code GSK2190915
    D.3.4Pharmaceutical form Oral liquid
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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
    Subjects with bronchial asthma, in the age of 18-55 years
    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 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 the late asthmatic response (LAR) to inhaled allergen in mild asthmatic subjects compared with placebo.
    • To assess the safety and tolerability of repeat oral doses of GSK2190915 in mild
    asthmatic subjects compared with placebo.
    • To evaluate the effect on lung function as measured by FEV1 on Days 1, 3 and 6 in subjects with mild asthma compared with placebo.
    • To evaluate the effect of treatment with repeat oral doses of GSK2190915 on
    concentrations of exhaled nitric oxide on Days 1, 3, 4 and 6 in subjects with mild
    asthma compared with placebo.
    • To evaluate the effect on induced sputum post allergen challenge.
    • To evaluate the effect on bronchial hyperreactivity
    as measured by methacholine challenge on day 4 compared with placebo
    in mild asthmatic subjects.
    • To evaluate the effect on LTE4 and LTB4.
    • To explore PK/PD relationship on EAR and LTE4, LTB4 activity in mild
    asthmatic subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and females aged 18 to 55 years inclusive.
    2. Body mass index within the range 18.5-35.0 kg/m
    3. Female subjects must be of non-childbearing potential including pre-menopausal
    females with documented (medical report verification) hysterectomy or double
    oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and
    estradiol < 40 pg/ml (<140 pmol/L) or 6 weeks postsurgical bilateral oophorectomy
    with or without hysterectomy.
    4. Male subjects must agree to use one of the contraception methods listed in
    Section 8.1. This criterion must be followed from the time of the first dose of study
    medication until 5 terminal half-live post-last dose.
    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. Sensitivity to methacholine with a provocative concentration of methacholine
    resulting in a 20% fall in FEV1 (PC20 methacholine) of <8 mg/mL at screening
    8. Subjects who are able to produce acceptable induced sputum samples (as defined in the Study procedures Manual).
    9. Subjects who are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of ≤ 10 pack years.
    10. Demonstration of a positive wheal and flare reaction (≥ 3 mm relative to negative
    control) to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair) on skin prick testing at screening, or within 12 months of study start.
    11. Screening allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of ≥ 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of ≥ 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final
    concentration of allergen.
    12. Signed and dated written informed consent is obtained from the subject
    13. The subject is able to understand and comply with the protocol requirements,
    instructions and protocol-stated restrictions.
    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.
    Hypertension at screening is defined as persistent systolic BP >150 mmHg or
    diastolic BP > 90mmHg.
    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.
    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, other than short acting inhaled beta-agonists and
    paracetamol (up to 4 g per day) for the treatment of minor ailments eg headache from 14 days before screening until the follow-up visit.
    9. Unable to abstain from short acting beta agonists as described in the restrictions
    section.
    10. 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%.
    11. 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.
    12. History of being unable to tolerate or complete methacholine and/or allergen
    challenge tests.
    13. Subject is undergoing allergen desensitisation therapy.
    14. There is a risk of non-compliance with study procedures.
    15. History of blood donation (500 mL) within 3 months of starting the clinical study.
    16. The subject regularly drinks more than 28 units of alcohol in a week if male, or 21
    units per week if female. One unit of alcohol is defined as a medium (125 ml) glass
    of wine, half a pint (250 ml) of beer or one measure (25 ml) of spirits.
    17. 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 (e.g. poorly defined termination of the T-wave).
    18. The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
    19. The subject has tested positive for HIV antibodies.
    20. The subject has a positive pre-study urine cotinine/ breath carbon monoxide test or urine drug or urine or breath alcohol screen. A minimum list of drugs that will be
    screened for include Amphetamines, Barbituates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
    E.5 End points
    E.5.1Primary end point(s)
    Minimum EAR: the minimum FEV1 value between 0-2 hours post-challenge
    (primary endpoint)
    Weighted Mean EAR: the weighted mean of the FEV1 values between 0-2 hours
    post-challenge (primary endpoint)
    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 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 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    last subject last visit
    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 months3
    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 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 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    shortacting beta-agonists should not be administered within 8 hours prior to an allergen challenge, methacholine challenge, dosing with study drug or any lung function assessment unless deemed necessary by the investigator to relieve acute
    bronchoconstriction. Subject will be put on their regular treatment after finishing the study
    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 Decision2008-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-11
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