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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-005645-31
    Sponsor's Protocol Code Number:205540
    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:2016-05-16
    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 number2015-005645-31
    A.3Full title of the trial
    A randomised, double-blind (sponsor open) placebo-controlled, parallel group,
    8-week treatment study to investigate the safety, pharmacodynamics, and effect of the TLR7 agonist, GSK2245035, on the allergen-induced asthmatic response in subjects with mild allergic asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    8 week study in asthmatic patients to look at the safety and effect of GSK2245035 on their asthmatic response after allergen exposure.
    A.3.2Name or abbreviated title of the trial where available
    Phase 2a 8 week study of GSK2245035 in asthmatic patients
    A.4.1Sponsor's protocol code number205540
    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 SponsorGlaxoSmithKline Research & Development Ltd
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 800 783 9733
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameGSK2245035
    D.3.2Product code GSK2245035
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 1325212-97-2
    D.3.9.2Current sponsor codeGSK2245035
    D.3.9.3Other descriptive nameGSK2245035
    D.3.9.4EV Substance CodeSUB73016
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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) 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 No
    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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild allergic asthma
    E.1.1.1Medical condition in easily understood language
    Mild allergic asthma
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 100000004855
    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 i.n. GSK2245035 compared to placebo on the allergen-induced late asthmatic response (LAR) in subjects with allergic asthma.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of treatment with i.n. GSK2245035 compared to placebo on the allergen-induced early asthmatic response (EAR) in subjects with allergic asthma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    AGE
    1. Between 18 and 65 years of age inclusive, at the time of signing the informed consent.
    TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
    2. Diagnosis of asthma, as defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiratory airflow limitation [GINA guideline, 2015] for at least 6 months prior to screening.
    3. Current asthma therapy. Intermittent short-acting beta-agonist (SABA) alone (on average for no more than 2 days per week)
    4. Positive skin prick test (3 mm or more greater than negative control) to common perennial or seasonal aeroallergen(s) (i.e., house dust mite, cat dander, grass pollen) at screening.
    5. Pre-bronchodilator FEV1 > 70 % predicted normal at Screening Visit 1. NOTE: Predicted values will be based upon Quanjer, 2012.
    6. EAR with ≥20 % FEV1 decrease between 5 and 30 minutes after the final allergen concentration is obtained at the screening bronchial allergen challenge (decreases
    relative to the saline).
    7. LAR with three FEV1 decreases of ≥15 % between 4 and 10 hours after the final allergen concentration is obtained at the screening bronchial allergen challenge, with two FEV1 decreases being at consecutive time points (decreases relative to the saline).
    8. Subjects who are current non-smokers (defined as no use of any tobacco products in the 6-month period preceding the screening visit) and have a pack history of < 10 pack years Number of pack years = (number of cigarettes per day/20) x number of years smoked WEIGHT
    9. Bodyweight ≥ 45kg
    SEX
    10. Male OR female of non-reproductive potential Males:
    Male subjects with female partners of child bearing potential must comply with one of the following contraception requirements from the time of first dose of study medication until the final follow-up visit.
    a. Vasectomy with documentation of azoospermia.
    b. Male condom plus partner use of one of the contraceptive options below:
    - Contraceptive subdermal implant
    - Intrauterine device or intrauterine system
    - Oral contraceptive, either combined or progestogen alone [Hatcher, 2007a] Injectable progestogen [Hatcher, 2007a]
    - Contraceptive vaginal ring [Hatcher, 2007a]
    - Percutaneous contraceptive patches [Hatcher, 2007a]
    This is an all-inclusive list of those methods that meet the following GSK definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product
    methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International
    Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) [ICH M3 (R2) 2009].”
    The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
    Females:
    A female subject is eligible to participate if she is not pregnant (as confirmed by a negative [serum or urine] human chorionic gonadotrophin (hCG) test), not lactating, and where the following condition applies:
    Non-reproductive potential defined as:
    - Pre-menopausal females with one of the following:
    - Documented tubal ligation
    - Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
    - Hysterectomy
    - Documented Bilateral Oophorectomy
    Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to
    laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
    INFORMED CONSENT
    11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION AND QTc INTERVAL)
    1. Alanine transaminase (ALT) >2xUpper Limit of Normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
    3. Heart rate corrected QT interval (QTc) > 450 msec or QTc > 480 msec in subjects with Bundle Branch Block
    NOTES:
    - The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), or another method, machine-read or manually over-read.
    - The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to
    calculate the QTc for an individual subject and then the owest QTc value used to include or discontinue the subject from the trial.
    - For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP).
    4. Asthma exacerbation requiring treatment with oral corticosteroids or hospitalization within 3 months prior to screening
    5. History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years.
    6. Evidence of concurrent respiratory diseases such as pneumonia, pneumothroax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis,
    cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma.
    7. Other concurrent diseases/abnormalities: A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the
    investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
    8. Respiratory tract infection that is not resolved within 2 weeks prior to screening.
    CONCOMITANT MEDICATIONS
    9. Treatment with intranasal steroid, inhaled corticosteroid (ICS) with or without longacting beta2-agonist (LABA), and treatment with non-ICS controller asthma medications (i.e., leukotriene modifier, methylxanthines) within 4 weeks prior to screening.
    10. Use of antihistamines within 7 days' or short-acting antihistamines within 72 hours prior to the screening skin prick test.
    11. Treatment with systemic corticosteroids within 6 weeks prior to screening.
    12. Use of inhaled SABAs as rescue treatment on average for more than 2 days per week.
    RELEVANT HABITS
    13. History of regular alcohol consumption within 6 months of the study defined as:
    An average weekly intake of >14 units for males and females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
    CONTRAINDICATIONS
    14. Patient known to be intolerant to salbutamol or albuterol.
    15. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK
    Medical Monitor, contraindicates their participation.
    DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
    16. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, subjects with presence of hepatitis B core antibody (HBcAb) should also be excluded.
    17. A positive pre-study drug/alcohol screen
    18. A positive test for Human Immunodeficiency Virus (HIV) antibody
    19. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
    20. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current
    study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
    21.Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day
    E.5 End points
    E.5.1Primary end point(s)
    Late Asthmatic Response: minimum FEV1 between 4-10 hours following allergen challenge one week after treatment.
    Late Asthmatic Response: weighted mean FEV1 between 4-10 hours following allergen challenge one week after treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    FEV1 values up to 10 hours following administration of the bronchial allergen challenge
    E.5.2Secondary end point(s)
    Early Asthmatic Response: minimum FEV1 between 0-2 hours following allergen challenge one week after treatment.
    Early Asthmatic Response: weighted mean FEV1 between 0-2 hours following allergen challenge one week after treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    FEV1 values up to 2 hours following administration of the bronchial allergen challenge
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 No
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 60
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Subjects will not receive any additional treatment from GSK after completion of the study because the indication being studied is not life-threatening or seriously debilitating and other treatment options are available.

    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the subject’s medical condition, whether or not GSK is providing specific post-study treatment.
    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 Decision2016-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-04
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