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    Clinical Trial Results:
    A Randomized, Double Blind, Single Dose, Crossover Study, in Subjects with Mild to Moderate Asthma, to Compare the Pharmacodynamic (Bronchodilator) Responses of 12.5/250 µg and 50/250 µg Salmeterol / Fluticasone Propionate (SAL/FP) Delivered Via a Novel Dry Powder Inhaler Device PulmoJet® Versus the Seretide Diskus® 50/250

    Summary
    EudraCT number
    		 2014-005047-40
    Trial protocol
    		 DE   GB   BG  
    Global end of trial date
    25 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2016
    First version publication date
    31 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SIT001-12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Aventis
    Sponsor organisation address
    de Montfleury 3, Vernier, Switzerland,
    Public contact
    Michael Klein, Zentiva Inhalationsprodukte GmbH Staffelseestr. 4 81477 Munich, +49 89710502130, michael.klein@zentiva.de
    Scientific contact
    Michael Klein, Zentiva Inhalationsprodukte GmbH Staffelseestr. 4 81477 Munich, +49 89710502130, michael.klein@zentiva.de
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to demonstrate the therapeutic non-inferiority of the bronchodilator responses (area under the time curve of forced expiratory volume in 1 second [AUC-FEV1]) over 12 hours of the salmeterol component (50 µg) of a novel SAL/FP combination dry powder inhaler product (PulmoJet 50 µg/250 µg SAL/FP; test) with the respective mid-strength of the European reference product (Seretide Diskus; reference).
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Apr 2015
    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
    United Kingdom: 107
    Country: Number of subjects enrolled
    Bulgaria: 22
    Country: Number of subjects enrolled
    Germany: 111
    Worldwide total number of subjects
    240
    EEA total number of subjects
    240
    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)
    13
    Adults (18-64 years)
    227
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 9 sites in 3 countries. A total of 240 subjects (227 adults and 13 adolescents) enrolled in the study.

    Pre-assignment
    Screening details
    		 From 240 subjects enrolled in the study, 124 subjects (112 adults and 12 adolescents) met the entry criteria, and 123 subjects (111 adults and 12 adolescents) were randomly assigned. One subject was randomized in error and immediately discontinued prior to receiving study drug.

    Pre-assignment period milestones
    Number of subjects started
    		 240
    Number of subjects completed
    		 122

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 4
    Reason: Number of subjects
    		 Failed Inclusion/Exclusion Criterion: 112
    Reason: Number of subjects
    		 randomised in error: 1
    Reason: Number of subjects
    		 Physician decision: 1
    Period 1
    Period 1 title
    Treatment B
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Arm title
    		 Test 2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    PulmoJet 50/250 SAL/FP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Single-dose, Dose per inhalation SAL: 50 μg, FP: 250 μg

    Investigational medicinal product name
    Seretide Diskus Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Lactose Monohydrate, Single-dose

    Number of subjects in period 1 [1]
    		Test 2
    Started
    122
    Completed
    117
    Not completed
    5
         Meet the Stopping Criteria: Stability
    4
         Lost to follow-up
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 240 subjects (227 adults and 13 adolescents) enrolled in the study, 124 subjects (112 adults and 12 adolescents) met the entry criteria, and 123 subjects (111 adults and 12 adolescents) were randomly assigned. One subject was randomized in error and immediately discontinued prior to receiving study drug. The remaining 122 randomised subjects received Treatment. Treatment B was set as baseline period.
    Period 2
    Period 2 title
    Treatment A
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Arm title
    		 Test 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    PulmoJet 12.5/250 SAL/FP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Single-dose, Dose per inhalation SAL: 12.5 μg, FP: 250 μg

    Investigational medicinal product name
    Seretide Diskus Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Lactose Monohydrate, Single-dose

    Number of subjects in period 2
    		Test 1
    Started
    117
    Completed
    117
    Period 3
    Period 3 title
    Treatment C
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Arm title
    		 Reference
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Seretide Diskus 50/250 SAL/FP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Single-dose, Dose per inhalation SAL: 50 μg, FP: 250 μg

    Investigational medicinal product name
    PulmoJet SAL/FP Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Lactose Monohydrate, Single-dose

    Number of subjects in period 3
    		Reference
    Started
    117
    Completed
    117

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment B
    Reporting group description
    		 -

    Reporting group values
    		 Treatment B Total
    Number of subjects
    		 122 122
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.3 ( 13.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 37
        Male
    		 85 85

    End points

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    End points reporting groups
    Reporting group title
    Test 2
    Reporting group description
    		 -
    Reporting group title
    Test 1
    Reporting group description
    		 -
    Reporting group title
    Reference
    Reporting group description
    		 -

    Primary: baseline-adjusted positive-shifted FEV1-AUC0-12

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    End point title
    		 baseline-adjusted positive-shifted FEV1-AUC0-12
    End point description
    End point type
    Primary
    End point timeframe
    after each dosing
    End point values
    		 Test 2 Reference
    Number of subjects analysed
    117
    117
    Units: L•h
        arithmetic mean (standard deviation)
    9.244 ( 4.354 )
    8.478 ( 4.063 )
    Statistical analysis title
    		 bronchodilator response B/C
    Comparison groups
    Reference v Test 2
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2706
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.16
    Variability estimate
    Standard deviation

    Secondary: Duration of Bronchodilatation

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    End point title
    		 Duration of Bronchodilatation
    End point description
    End point type
    Secondary
    End point timeframe
    after every dosing
    End point values
    		 Test 2 Reference
    Number of subjects analysed
    117
    117
    Units: hour
        arithmetic mean (standard deviation)
    7.27 ( 5.043 )
    6.3 ( 5.089 )
    Statistical analysis title
    		 Duration of Bronchodilatation B/C
    Comparison groups
    Test 2 v Reference
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0125
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.62
    Variability estimate
    Standard deviation

    Secondary: Maximum Spirometry (FEV1)

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    End point title
    		 Maximum Spirometry (FEV1)
    End point description
    End point type
    Secondary
    End point timeframe
    after every dosing
    End point values
    		 Test 2 Reference
    Number of subjects analysed
    117
    117
    Units: Liters
        arithmetic mean (standard deviation)
    3.366 ( 0.84563 )
    3.2963 ( 0.8187 )
    Statistical analysis title
    		 Maximum FEV1 B/C
    Comparison groups
    Test 2 v Reference
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 0.1
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit regardless of seriousness or relationship to investigational product
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Test 2
    Reporting group description
    		 -

    Reporting group title
    Test 1
    Reporting group description
    		 -

    Reporting group title
    Reference
    Reporting group description
    		 -

    Serious adverse events
    		 Test 2 Test 1 Reference
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Test 2 Test 1 Reference
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 117 (20.51%)
    28 / 117 (23.93%)
    27 / 117 (23.08%)
    Investigations
    Investigations
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 117 (0.85%)
    2 / 117 (1.71%)
         occurrences all number
    1
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 117 (9.40%)
    15 / 117 (12.82%)
    10 / 117 (8.55%)
         occurrences all number
    16
    15
    13
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 117 (1.71%)
    0 / 117 (0.00%)
    0 / 117 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Gastrointestinal Disorders
         subjects affected / exposed
    5 / 117 (4.27%)
    6 / 117 (5.13%)
    2 / 117 (1.71%)
         occurrences all number
    7
    7
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 117 (0.85%)
    2 / 117 (1.71%)
    1 / 117 (0.85%)
         occurrences all number
    1
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, Thoracic and Mediastinal Disorders
         subjects affected / exposed
    3 / 117 (2.56%)
    3 / 117 (2.56%)
    7 / 117 (5.98%)
         occurrences all number
    3
    3
    7
    Skin and subcutaneous tissue disorders
    Skin and Subcutaneous Tissue Disorders
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 117 (0.85%)
    1 / 117 (0.85%)
         occurrences all number
    1
    1
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    5 / 117 (4.27%)
         occurrences all number
    0
    0
    5
    Rhinitis
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 117 (0.00%)
    2 / 117 (1.71%)
         occurrences all number
    0
    0
    2

    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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