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    Clinical Trial Results:
    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])

    Summary
    EudraCT number
    		 2014-004583-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 Sep 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    24 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P08212
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01566149
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck: MK-0887A-206
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Sep 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the safety, tolerability, and effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults and adolescents.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 Asthma
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Vietnam: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    44
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from one study site in Vietnam between March 2012 and September 2012.

    Pre-assignment
    Screening details
    		 Participants who were previously on medium-dose asthma medication were assigned to Mometasone Furoate/Formoterol Fumarate (MF/F) 200/10 mcg Metered Dose Inhaler (MDI) twice daily (BID) and participants who were previously on high-dose asthma medication were assigned to MF/F 400/10 mcg MDI BID.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MF/F 400/10 mcg MDI BID
    Arm description
    		 Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI)
    Investigational medicinal product code
    Other name
    SCH 418131, MK-0887A
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF/F MDI, with Mometasone Furoate at doses of 200 mcg or 400 mcg, and Formoterol Fumarate at a dose of 10 mcg

    Arm title
    		 MF/F 200/10 mcg MDI BID
    Arm description
    		 Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI)
    Investigational medicinal product code
    Other name
    SCH 418131, MK-0887A
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF/F MDI, with Mometasone Furoate at doses of 200 mcg or 400 mcg, and Formoterol Fumarate at a dose of 10 mcg

    Number of subjects in period 1
    		MF/F 400/10 mcg MDI BID MF/F 200/10 mcg MDI BID
    Started
    25
    24
    Completed
    23
    21
    Not completed
    2
    3
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    -
         Non-compliance with study medication
    -
    2
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MF/F 200/10 mcg MDI BID
    Reporting group description
    		 Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks

    Reporting group title
    MF/F 400/10 mcg MDI BID
    Reporting group description
    		 Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks

    Reporting group values
    		 MF/F 200/10 mcg MDI BID MF/F 400/10 mcg MDI BID Total
    Number of subjects
    		 24 25 49
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 4 0 4
        Adults (18-64 years)
    		 20 24 44
        From 65-84 years
    		 0 1 1
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.4 ( 14.48 ) 41.2 ( 14.91 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 14 12 26
        Male
    		 10 13 23

    End points

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    End points reporting groups
    Reporting group title
    MF/F 400/10 mcg MDI BID
    Reporting group description
    		 Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks

    Reporting group title
    MF/F 200/10 mcg MDI BID
    Reporting group description
    		 Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks

    Primary: Number of Participants with At Least One Adverse Event (AE)

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    End point title
    		 Number of Participants with At Least One Adverse Event (AE) [1]
    End point description
    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. This endpoint was based on the Full Analysis Set (FAS) population, which consisted of all participants assigned treatment who received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Up to Week 14
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed for the end point Number of Participants with At Least One Adverse Event (AE).
    End point values
    		 MF/F 200/10 mcg MDI BID MF/F 400/10 mcg MDI BID
    Number of subjects analysed
    24
    25
    Units: participants
        number (not applicable)
    5
    8
    No statistical analyses for this end point

    Primary: Number of Participants with At Least One Drug-Related AE

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    End point title
    		 Number of Participants with At Least One Drug-Related AE [2]
    End point description
    A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator. This endpoint was based on the FAS population, which consisted of all participants assigned treatment who received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Up to Week 14
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed for the end point Number of Participants with At Least One Drug-Related AE.
    End point values
    		 MF/F 200/10 mcg MDI BID MF/F 400/10 mcg MDI BID
    Number of subjects analysed
    24
    25
    Units: participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with At Least One Serious AE

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    End point title
    		 Number of Participants with At Least One Serious AE [3]
    End point description
    A serious AE was defined as any untoward medical occurrence or effect that at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer. This endpoint was based on the FAS population, which consisted of all participants assigned treatment who received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Up to Week 14
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed for the end point Number of Participants with At Least One Serious AE.
    End point values
    		 MF/F 200/10 mcg MDI BID MF/F 400/10 mcg MDI BID
    Number of subjects analysed
    24
    25
    Units: participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants Who Discontinued from the Study Due to an AE

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    End point title
    		 Number of Participants Who Discontinued from the Study Due to an AE [4]
    End point description
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. This endpoint was based on the FAS population, which consisted of all participants assigned treatment who received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Up to Week 12
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed for the end point Number of Participants Who Discontinued from the Study Due to an AE.
    End point values
    		 MF/F 200/10 mcg MDI BID MF/F 400/10 mcg MDI BID
    Number of subjects analysed
    24
    25
    Units: participants
        number (not applicable)
    0
    1
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12

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    End point title
    		 Mean Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
    End point description
    Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%. This endpoint was based on the FAS population, which consisted of all participants assigned treatment who received at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 MF/F 200/10 mcg MDI BID MF/F 400/10 mcg MDI BID
    Number of subjects analysed
    24
    25
    Units: liters
    arithmetic mean (standard deviation)
        Baseline FEV1
    2.397 ( 0.6824 )
    2.215 ( 0.6206 )
        Week 12 FEV1
    2.503 ( 0.7418 )
    2.27 ( 0.6041 )
        Change from Baseline in FEV1 at Week 12
    0.106 ( 0.2892 )
    0.054 ( 0.2055 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 14
    Adverse event reporting additional description
    The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    MF/F 400/10 mcg MDI BID
    Reporting group description
    		 Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks

    Reporting group title
    MF/F 200/10 mcg MDI BID
    Reporting group description
    		 Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks

    Serious adverse events
    		 MF/F 400/10 mcg MDI BID MF/F 200/10 mcg MDI BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MF/F 400/10 mcg MDI BID MF/F 200/10 mcg MDI BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 25 (32.00%)
    5 / 24 (20.83%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    Cough
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 24 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 24 (12.50%)
         occurrences all number
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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