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    Summary
    EudraCT Number:2014-004749-28
    Sponsor's Protocol Code Number:MK-0476-334
    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 number2014-004749-28
    A.3Full title of the trial
    MK-476 Phase III Open Label Exploratory Comparative Study -Acute Exacerbations of Asthma-
    Protocol number: 334
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Acute Exacerbations of Asthma
    A.3.2Name or abbreviated title of the trial where available
    MK-476 Phase III Open Label Exploratory Comparative Study -Acute Exacerbations of Asthma
    A.4.1Sponsor's protocol code numberMK-0476-334
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00442338
    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 SponsorBanyu Pharmaceutical Co., Ltd.
    B.1.3.4CountryJapan
    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 supportBanyu Pharmaceutical Co. Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBanyu Pharmaceutical Co. Ltd
    B.5.2Functional name of contact pointSatoru Hisada
    B.5.3 Address:
    B.5.3.1Street AddressKitanomaru-Square 1-13-12 Kudankita
    B.5.3.2Town/ cityChiyoda-ku, Tokyo
    B.5.3.3Post code102-8667
    B.5.3.4CountryJapan
    B.5.4Telephone number03-6272- 2012
    B.5.5Fax number03-6238-9091
    B.5.6E-mailsatoru.hisada@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 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 nameMontelukast Sodium
    D.3.2Product code MK-0476E
    D.3.4Pharmaceutical form Lyophilisate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 number7
    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 Kyophyllin® Injection
    D.2.1.1.2Name of the Marketing Authorisation holderKyorin Pharmaceutical
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameKyophyllin® Injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMINOPHYLLINE
    D.3.9.1CAS number 317-34-0
    D.3.9.4EV Substance CodeSUB05444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Acute Exacerbations of Asthma
    E.1.1.1Medical condition in easily understood language
    Acute Asthma
    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
    To estimate the improvement in FEV1 of intravenous (IV) MK-476 7 mg, 14 mg and Aminophylline IV drip in patient with acute asthma.
    To examine the safety and tolerability of MK-476 7 mg, 14 mg IV and Aminophylline IV drip.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age: between 15 and 75 years of age.
    Gender: irrelevant
    All females must demonstrate a urine -hCG level consistent with the nongravid state (it’s not necessary if 3 years have passed since the onset of menopause, and if pregnancy is organically impossible).Patient has at least a 1 year history of asthma.
    Patient understands the study procedures and agrees to participate as indicated by signing the appropriate informed consent.
    All females must demonstrate a urine -hCG level consistent with the nongravid state prior to random allocation. Patient is admitted to the study site because of an acute exacerbation of asthma. Patient has a forced expiratory volume in 1 second (FEV1) of < 70% of the predicted value at each evaluation. Patient is able to perform reproducible pulmonary tests (spirometry) as described Protocol. Patient agrees to administration of study drug as indicated by signing the confirmation slip.
    E.4Principal exclusion criteria
    Patient has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
    The patient’s asthma has lifethreatening features, including, but not limited to, immediate respiratory failure, the need for intubation, evidence of a pneumothorax or pneumomediastinum.
    The patient is febrile (temperature >38.0°C) OR has signs or symptoms of pneumonia in Screening period.
    The time in Screening period (between initiation of first -agonist nebulization after study site admission and study drug administration) exceeds 60 minutes..
    The percent predicted FEV1 value has increased or decreased by 20 percentage points between 2 measurements during Screening period.
    Patient has FEV1 of <30% of the predicted value or Spo2 <90% during Screening period.
    Patient has any comorbid disorder that would require therapy during Screening period and Treatment period.
    Patient has received any dose of corticosteroids (other than their usual dose and other than percutaneous, eye drop, and nasal drops) within 6 hours of starting Screening period.
    E.5 End points
    E.5.1Primary end point(s)
    The time weighted average change in FEV1 from preallocation baseline over the first 60 minutes from the point of 5minutes after beginning of study drug administration [average  FEV1 (0-60 min)].
    E.5.1.1Timepoint(s) of evaluation of this end point
    FEV1 (0-60 min)
    E.5.2Secondary end point(s)
    The time weighted average percent change in FEV1 from preallocation baseline over the first 60 minutes from the point of 5minutes after beginning of study drug administration [average %  FEV1 (0-60 min)].
    The time weighted average change and percent change in FEV1 from preallocation baseline over the first 120, 90, 40, 20 minutes from the point of 5minutes after beginning of study drug administration.
    The change and the percent change in FEV1 from preallocation baseline at 10, 20, 40, 60, 90, and 120 minutes from the point of 5minutes after beginning of study drug administration.
    The percentage of patients having received corticosteroids.
    The total number of doses of β-agonist per patient.
    Patient’s global evaluation.
    Investigator’s global evaluation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    FEV1 (0-60 min)
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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
    When the protocol-defined regimen of dosage, observations and tests are finally completed in the last patient at the institutional site, the investigator will report to the institutional head in writing the completion of this study with an outlined study results attached.
    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 months10
    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: 30
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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
    adolescent
    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 91
    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)
    All patients who complete Treatment period are followed up by telephone or admission in order to confirm whether or not have AEs up to 14 days after study drug administration.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SRL Medisearch Inc.
    G.4.3.4Network Country Japan
    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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