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    Summary
    EudraCT Number:2014-004748-37
    Sponsor's Protocol Code Number:MK-0476-367
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-03
    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 number2014-004748-37
    A.3Full title of the trial
    Korean Study of “Real-world” Montelukast Use in Mild Asthmatic Children with Concomitant Allergic Rhinitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Montelukast Use in Mild Asthmatic Children with Allergic Rhinitis
    A.3.2Name or abbreviated title of the trial where available
    Montelukast Use in Mild Asthmatic Children with Allergic Rhinitis
    A.4.1Sponsor's protocol code numberMK-0476-367
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00442559
    A.5.4Other Identifiers
    Name:Other identifierNumber:SGA-M-10-00
    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 SponsorMSD Korea LTD.
    B.1.3.4CountryKorea, Republic of
    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 supportMSD Korea LTD.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Korea LTD.
    B.5.2Functional name of contact pointSang Won Park
    B.5.3 Address:
    B.5.3.1Street Address12F1., SK Life Insurance Building, 168 Gongduk-Dong
    B.5.3.2Town/ cityMapo-Ku, Seoul
    B.5.3.3Post code121-705
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82-2-331-2228
    B.5.6E-mailsang.won.park@merck.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 Yes
    D.2.1.1.1Trade name SINGULAIR
    D.2.1.1.2Name of the Marketing Authorisation holderMSD-Korea, LTD.
    D.2.1.2Country which granted the Marketing AuthorisationKorea, Republic of
    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 nameSingulair
    D.3.2Product code MK-0476
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMontelukast Sodium
    D.3.9.1CAS number 158966-92-8
    D.3.9.3Other descriptive nameMONTELUKAST SODIUM
    D.3.9.4EV Substance CodeSUB03324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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 Yes
    D.2.1.1.1Trade name SINGULAIR
    D.2.1.1.2Name of the Marketing Authorisation holderMSD-Korea, LTD.
    D.2.1.2Country which granted the Marketing AuthorisationKorea, Republic of
    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 nameSINGULAIR
    D.3.2Product code MK-0476
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMontelukast sodium
    D.3.9.1CAS number 158966-92-8
    D.3.9.3Other descriptive nameMONTELUKAST SODIUM
    D.3.9.4EV Substance CodeSUB03324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    mild asthma and allergic rhinitis
    E.1.1.1Medical condition in easily understood language
    asthma and allergies
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess real-world effectiveness of Montelukast in Children (2 – 14 years) with asthma and allergic rhinitis.
    2. To evaluate asthma-related medical resource use during 12 months following Montelukast and ICS treatment.
    3. To establish a benchmark group using ICS treatment under usual circumstances to compare changes in effectiveness from baseline and track resource use.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Patients’ caregiver understands the study procedures and agrees to
    participate by signing the appropriate informed consent form.
    b. Patient is a male or female and between the ages of 2 and 14 years
    (inclusive) at Visit 1.
    c. Patients diagnosed with asthma, classified as mild persistent asthma
    according to GINA guidelines at the time of inclusion.
    d. Patients diagnosed with comorbid allergic rhinitis.
    E.4Principal exclusion criteria
    a. Prior treatment with high dose ICS (i.e., requires a dose higher than beclomethasone dipropionate 400 μg per day, or equivalent), other medications used in severe cases.
    b. Patients with suspected rhino-sinusitis (i.e., fetid breathing, mucopurulent nasal discharge, post nasal drip, X-ray finding etc.)
    c. Patients with cystic fibrosis, congenital heart disease.
    d. Patients with Chinese medication use at inclusion.
    e. Inappropriate patients with investigator judgment.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint will be Daytime Asthma Symptom Score at 12 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    At 2 weeks: Daily Rhinitis Symptom Score, Daytime Asthma Symptom Score
    At 12 weeks: Daily Rhinitis Symptom Score, Daily Asthma Symptom Score, ‘as-needed’ Short acting β-agonist use, Overnight asthma symptoms score, frequency of asthma attacks and asthma exacerbations, the number of asthma free days, Global Asthma Assessment by Patient/Caregiver and by Physician, Global Allergic Rhinitis Assessment
    by Patient/Caregiver and by Physician, Willingness to Continue Therapy, Adherence Rate.
    At 12 months: Asthma-related medical resources use including SABA, CS, unscheduled office visits for asthma, emergency department visits, frequency of hospitalizations, assessment of OTC and alternative medication use, allergic rhinitis medication use.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 2 weeks: Daily Rhinitis Symptom Score, Daytime Asthma Symptom Score
    At 12 weeks: Daily Rhinitis Symptom Score, Daily Asthma Symptom Score, ‘as-needed’ Short acting β-agonist use, Overnight asthma symptoms score, frequency of asthma attacks and asthma exacerbations, the number of asthma free days, Global Asthma Assessment by Patient/Caregiver and by Physician, Global Allergic Rhinitis Assessment
    by Patient/Caregiver and by Physician, Willingness to Continue Therapy, Adherence Rate.
    At 12 months: Asthma-related medical resources use including SABA, CS, unscheduled office visits for asthma, emergency department visits, frequency of hospitalizations, assessment of OTC and alternative medication use, allergic rhinitis medication use.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    ICS chosen by PI
    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
    Korea, Republic of
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 191
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 95
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 96
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children between the ages of 2 and 14 years
    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 200
    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)
    No
    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: Korea, Republic of
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