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    Summary
    EudraCT Number:2016-003479-22
    Sponsor's Protocol Code Number:200860
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-11-09
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2016-003479-22
    A.3Full title of the trial
    Clinical assessment of fluticasone propionate/ salmeterol xinafoate HFA MDI in 6-month to 4-year-old Japanese patients with bronchial asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical assessment of fluticasone propionate/ salmeterol xinafoate HFA MDI in 6-month to 4-year-old Japanese patients with bronchial asthma
    A.4.1Sponsor's protocol code number200860
    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 and 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 Research and development Ltd
    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 Address1-3 Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0800 783 9733
    B.5.5Fax numberNot Applicable
    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 nameFluticasone Propionate/salmeterol
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    D.3.4.1Specific paediatric formulation Yes
    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 INNSALMETEROL XINAFOATE
    D.3.9.1CAS number 94749-08-3
    D.3.9.3Other descriptive nameSALMETEROL XINAFOATE
    D.3.9.4EV Substance CodeSUB04314MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Flixotide® Accuhaler®
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFlixotide® Accuhaler®
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    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 INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    bronchial asthma
    E.1.1.1Medical condition in easily understood language
    bronchial asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003555
    E.1.2Term Asthma bronchial
    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 efficacy and safety of fluticasone propionate (FP)/ salmeterol xinafoate (SLM) HFA MDI 50/25 µg 1 or 2 inhalation twice daily for 8 weeks in comparison with FP HFA MDI 50 µg 1 or 2 inhalation twice daily in 6-month to 4-year-old Japanese patients with infantile bronchial asthma.

    In addition, the safety of long-term treatment of FP/ SLM HFA MDI 50/25 µg 1 or 2 inhalation twice daily will be evaluated in the 16 weeks of extension period.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the product label, add other pertinent documents.
    Deviations from inclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
    Subjects eligible for enrolment in the study must meet all of the following criteria:
    1.Obtaining consent: The written informed consent must be obtained from his/her parent or legally acceptable representative. If the investigator (or subinvestigator) obtains the oral consent from the patient, the investigator (or subinvestigator) should record so in the informed consent form which is signed by his/her parent or legally acceptable representative.
    2.Race: Japanese
    3.Age: ≥ 6 months and ≤4 years at Visit 1.
    4.Sex: Male and premenarcheal female. Premenarcheal females are defined as any female who has yet to have menstruation.
    5.Patients: Outpatient
    6.Diagnosis of asthma: Diagnosis of infantile bronchial asthma is made by reference to JPGL2012 and the rationale is documented.
    As for diagnosis of children of < 2 years old, the following description in JPGL2012 should be referenced [Japanese Society of Pediatric Allergy and Clinical Immunology, 2011].
    - There are 3 or more episodes of obvious expiratory wheezing, regardless of the presence of respiratory tract infection. It is also needed to confirm that there is asymptomatic period for about a week between episodes.
    In addition to this finding, if there is at least one of the following findings, it is more helpful to diagnose infantile asthma,
    - At least one of parents is diagnosed with bronchial asthma by a physician (including past history).
    - Specific IgE antibody for inhalation antigen is detected in at least one of parents.
    - The diseased child is diagnosed with atopic dermatitis by a physician (including past history).
    - Specific IgE antibody for inhalation antigen is detected in the diseased child.
    - High serum IgE level in the diseased child or his/her family (serum IgE level should be determined in consideration of age).
    - Eosinophils and creola bodies found in the sputum (increased eosinophils in nasal discharge and peripheral blood will be referenced).
    - Expiratory wheezing occurs when seemingly there is no airway infection.
    - Expiratory wheezing and labored respiration or oxygen saturation are improved after beta-2 stimulant inhalation.
    7.Treatment of asthma: A patient who needs to be treated with ICS/LABA and fulfils all of the following conditions,
    •At least one documented asthma exacerbation in that the patient treated with systemic glucocorticosteroids, aminophylline intravenous drip infusion (continuous drip infusion) or continuous isoproterenol inhalation within the 12 months prior to Visit 1. Or a well-documented continuous treatment with ICS (FP 200-400 micro g daily or equivalent) within 12 months prior to Visit 1.
    •The patient has not received systemic glucocorticosteroids, aminophylline intravenous drip infusion (continuous drip infusion), ICS (FP > 200 micro g daily or equivalent) or continuous isoproterenol inhalation within 4 weeks prior to Visit 1.

    E.4Principal exclusion criteria
    Exclusion Criteria
    Deviations from exclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1.Concomitant medication (infectious diseases): A patient who had upper or lower respiratory tract infection and received concomitant medication within 2 weeks prior to Visit 1.
    2.Infectious diseases: A patient who has confirmatory diagnosis of upper or lower respiratory tract infection at Visit 1; or a patient who has or is suspected to have deep mycosis or infection for which no effective antibacterial agent is available; or a patient who is suspected to have RS virus infection and cannot be identified to be negative for RS virus antigen.
    3.Respiratory comorbidities: A patient who has respiratory disorder other than bronchial asthma, and the respiratory disorder is likely to have an impact on the assessment of efficacy in this study.
    4.Liver disease: A patient who has unstable liver disease or chronic stable hepatitis B, receiving immunosuppressive agents due to risk of hepatitis B reactivation.
    5.Other comorbidities: A patient who has malformation/foreign particle in an airway; or subjects who have known, pre-existing, clinically significant gastroesophageal reflux disease, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other abnormalities that are poorly controlled with standard treatment.
    6.Drug allergy/ hypersensitivity: A patient who has or is suspected to have hypersensitivity to study medications, rescue medication or any ingredients of them.
    7.Other studies/ study drug: A patient who participated in other studies/ trials and was treated with other investigational product(s) and 1 month has not elapsed at Visit 1 or the period of five-fold of the half-lives (t½) has not elapsed yet.
    8.ECG: As for the patients who has evaluable ECG data at Visit 1, QTc(F) is ≥450 msec. If the first assessment meets this criterion, ECG should be measured two more times with interval after the first ECG, and the mean value of the three assessments will be used for judgement.

    As for the patients who do not have evaluable ECG data at Visit 1, if the patient has known prolonged QTc (≥450 msec, any correction is valid), the patient will be excluded.
    9.Other: A patient who is child in care (including foster parent system), or whom the investigator (or subinvestigator) judges inappropriate for the study.
    E.5 End points
    E.5.1Primary end point(s)
    •Mean change from baseline in asthma symptom score (total of daytime and night-time) in patient diary at the end of the treatment period 1 among the subjects who have completed 8 weeks of treatment.
    The baseline value is the mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2).
    The value at the end of the treatment period 1 is the mean value of the last 7 consecutive days during the treatment period 1 (excluding the last day of the treatment period 1).
    The mean value of asthma symptom score (total of daytime and night-time) for at least 5 days is acceptable if some data are missing.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 8 weeks (visit 5/the end of period 1)
    E.5.2Secondary end point(s)
    •Mean change from baseline in night-time asthma symptom score
    •Mean change from baseline in daytime asthma symptom score
    •Frequency of asthma exacerbations
    •Use of rescue medication (number of occasions used during a 24-hour period and percentage of days with rescue-free 24-hour period)
    •QOL : Mean change from baseline in JPAC score
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 8 weeks (visit 5/the end of period 1)
    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 No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months38
    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 Yes
    F.1.1Number of subjects for this age range: 370
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 67
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 303
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 370
    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)
    The investigator (or subinvestigator) is responsible for ensuring that consideration has been given to the post-study care of the patient’s medical condition whether or not GSK is providing specific post-study treatment. After treatment period, the investigator (or subinvestigator) should prescribe asthma medication appropriate to the subject.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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