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    Summary
    EudraCT Number:2014-004583-38
    Sponsor's Protocol Code Number:P08212
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-05-06
    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 number2014-004583-38
    A.3Full title of the trial
    An Open-Label Study to Assess the Safety and Tolerability of Zenhale® (a Fixed-Dose Combination of Mometasone Furoate/Formoterol Fumarate Delivered by Metered Dose Inhaler) in 40 Subjects with Persistent Asthma (Protocol No. 206-00 [P08212])
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-Label Safety Study of MF/F in Asthma
    A.3.2Name or abbreviated title of the trial where available
    Open-Label Safety Study of MF/F in Asthma
    A.4.1Sponsor's protocol code numberP08212
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01566149
    A.5.4Other Identifiers
    Name:Protocol code numberNumber:MK-0887A-206
    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 SponsorSchering-Plough Research Institute, a division of Schering Corporation
    B.1.3.4CountryUnited States
    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 supportSchering-Plough Research Institute, a division of Schering Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchering-Plough Research Institute, a division of Schering Corporation
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street Address2015 Galloping Hill Road
    B.5.3.2Town/ cityKenilworth, NJ
    B.5.3.3Post code07033
    B.5.3.4CountryUnited States
    B.5.4Telephone number+84 83 9155803
    B.5.6E-mailtrong.son.than@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 nameMometasone Furoate and Formoterol Fumarate
    D.3.2Product code MK-0887A / SCH 418131
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 INNMometasone Furoate
    D.3.9.1CAS number 83919-23-7
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFormoterol Fumarate
    D.3.9.1CAS number 73573-87-2
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB25660
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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.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 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 nameMometasone Furoate and Formoterol Fumarate
    D.3.2Product code MK-0887A / SCH 418131
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 INNMometasone Furoate
    D.3.9.1CAS number 83919-23-7
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFormoterol Fumarate
    D.3.9.1CAS number 73573-87-2
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB25660
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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
    Persistent Asthma
    E.1.1.1Medical condition in easily understood language
    Persistent 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 assess the safety and tolerability of mometasone furoate/formoterol fumarate metered dose inhaler (MF/F MDI) 200/10 mcg or 400/10 mcg twice daily (BID) over 12 weeks as maintenance treatment in subjects with persistent asthma previously treated with medium- or high-dose inhaled glucocorticosteroids (ICS) either alone or in combination with long acting beta agonist (LABA).
    E.2.2Secondary objectives of the trial
    To assess the efficacy of MF/F 200/10 mcg or 400/10 mcg BID by evaluating the Week 12 change from Baseline in morning forced expiratory volume in one second (FEV1) at the end of the dosing interval (trough FEV1).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    A subject must be at least 12 years of age or older and of either sex.
    Each subject must be willing and able to provide written informed consent for the trial. The legal representative (eg, parent or guardian) for a subject under the age of legal consent, or who otherwise is unable to provide independent consent, may provide written informed consent for the subject. Each subject of the age of assent must be willing and able to provide assent, in addition to consent from the legal representative, to participate in the trial.
    A subject must have a diagnosis of asthma of at least 6 months duration that is consistent with the following definitions: the diagnosis of asthma is based upon clinical history and examination, pulmonary function parameters, and response to beta-2 agonists, according to international guidelines (GINA 2010).
    A subject must have been using a medium or high daily dose of ICS (either alone or in combination with
    LABA) for at least 6 weeks and must have been on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening.
    Medium daily doses of ICS are defined as follows (GINA 2010):
    >500 to 1000 mcg beclomethasone dipropionate
    >400 to 800 mcg budesonide DPI
    >160 to 320 mcg ciclesonide
    >1000 to 2000 mcg flunisolide
    >250 to 500 mcg fluticasone propionate
    >400 to <800 mcg mometasone furoate
    >1000 to 2000 mcg triamcinolone acetonide
    High daily doses of ICS are defined as follows (GINA 2010) :
    >1000 to 2000 mcg beclomethasone dipropionate
    >800 to 1600 mcg budesonide DPI
    >320 to 1280 mcg ciclesonide
    >2000 mcg flunisolide
    >500 to 1000 mcg fluticasone propionate
    ≥800 mometasone furoate
    >2000 mcg triamcinolone acetonide
    Both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk in the current study setting.
    At the Screening Visit, or thereafter but prior to the Baseline Visit, the subject must demonstrate an
    increase in absolute FEV1 of ≥12% and ≥200 mL within 15-20 minutes after administration of four
    inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg) or of nebulized SABA (2.5 mg), if confirmed as standard office practice. This requirement may be waived if there is documentation of post-SABA reversibility within 12 months prior to screening.
    At Screening and at Baseline, each subject must have a pre-bronchodilator FEV1 ≥60% predicted.
    Clinical laboratory tests (complete blood count, blood chemistries, urinalysis, and negative urine
    pregnancy test for females of child-bearing potential) conducted at the Screening Visit must be within
    normal limits or clinically acceptable to the investigator. If the laboratory value is not indicative of the
    subject’s clinical status, one repeat test may be performed. If repeat value does not meet the criterion, subject may not continue the screening process.

    Refer to protocol for complete list.
    E.4Principal exclusion criteria
    A subject who demonstrates a decrease in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit.
    A subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABAs) at any time from the Screening Visit up to and including the Baseline Visit.
    A subject who has been treated in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction within the last 3 months.
    A subject who has ever required ventilator support for respiratory failure secondary to asthma.
    A subject who has experienced an upper or lower respiratory tract infection (viral or bacterial) within the
    previous 2 weeks prior to Screening and Baseline Visits. Visits can be rescheduled 2 weeks after complete resolution of the event to re-assess eligibility.
    A subject who requires the use of >8 inhalations per day of SABA MDI or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit.
    A subject who is unable to perform acceptable and reproducible spirometry maneuvers at on-site visits or using the home PEF meter.
    A subject who has smoked within the previous year or an ex-smoker with a cumulative smoking history >10 pack-years.
    A subject who is known to be allergic to or intolerant. Refer to protocol for complete list.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints include the following:
    Clinical and laboratory adverse experiences, laboratory values, and vital signs. The number and percentage of patients will be provided for patients who have: (1) at least one AE, (2) at least one drug-related AE, (3) at least one serious AE, (4) discontinued treatment due to an AE, and (5) specific AEs.
    Serious adverse experiences and adverse experiences leading to discontinuation.
    Laboratory and vital sign measurements.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week -1, 0, 1, 4, 8, 12
    E.5.2Secondary end point(s)
    The Secondary Efficacy Endpoint for the current trial is the Week 12 change from Baseline in morning FEV1 at the end of the dosing interval (trough FEV1).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 0, 12
    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 Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    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 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? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    Vietnam
    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 years0
    E.8.9.2In all countries concerned by the trial months6
    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: 4
    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: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 49
    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)
    Standard of care
    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: Vietnam
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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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