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    Clinical Trial Results:
    A 52-week, Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP) DISKUS 250 mcg BID in Treatment of Subjects with Asthma

    Summary
    EudraCT number
    		 2015-004883-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Apr 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jan 2017
    First version publication date
    25 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ADA109057
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    08 Jul 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Apr 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    TBD
    Protection of trial subjects
    No Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 May 2007
    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
    Argentina: 155
    Country: Number of subjects enrolled
    Brazil: 39
    Country: Number of subjects enrolled
    Canada: 45
    Country: Number of subjects enrolled
    Philippines: 30
    Country: Number of subjects enrolled
    United States: 359
    Worldwide total number of subjects
    628
    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)
    67
    Adults (18-64 years)
    522
    From 65 to 84 years
    37
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 628 subjects were included in the ITT Population: 310 in the FSC DISKUS 250/50 group and 318 in the FP DISKUS 250 group. The majority of subjects in each treatment groups (75% in the FSC DISKUS 250/50 group and 74% in the FP 250 group) completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FSC DISKUS 250/50 mcg BID
    Arm description
    		 Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone Propionate/Salmeterol Combination (FSC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one inhalation of FSC 250/50 micrograms (mcg) via DISKUS twice daily (BID) for 52 weeks

    Arm title
    		 FP DISKUS 250 mcg BID for 52 weeks
    Arm description
    		 Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone Propionate (FP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one inhalation of FP 250 mcg via DISKUS BID for 52 weeks.

    Number of subjects in period 1
    		FSC DISKUS 250/50 mcg BID FP DISKUS 250 mcg BID for 52 weeks
    Started
    310
    318
    Completed
    231
    234
    Not completed
    79
    84
         Consent withdrawn by subject
    18
    21
         Adverse event, non-fatal
    6
    9
         Other
    9
    9
         Lost to follow-up
    14
    8
         Lack of efficacy
    10
    9
         Protocol deviation
    22
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FSC DISKUS 250/50 mcg BID
    Reporting group description
    		 Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks

    Reporting group title
    FP DISKUS 250 mcg BID for 52 weeks
    Reporting group description
    		 Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks

    Reporting group values
    		 FSC DISKUS 250/50 mcg BID FP DISKUS 250 mcg BID for 52 weeks Total
    Number of subjects
    		 310 318
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 40.9 ( 15.71 ) 39.6 ( 16.56 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 186 181 367
        Male
    		 124 137 261
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 254 262 516
        African American
    		 29 27 56
        Asian
    		 20 25 45
        American Indian
    		 2 0 2
        Other
    		 5 4 9

    End points

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    End points reporting groups
    Reporting group title
    FSC DISKUS 250/50 mcg BID
    Reporting group description
    		 Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks

    Reporting group title
    FP DISKUS 250 mcg BID for 52 weeks
    Reporting group description
    		 Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks

    Primary: Mean change from baseline in pre-dose FEV1 over Weeks 1-52

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    End point title
    		 Mean change from baseline in pre-dose FEV1 over Weeks 1-52
    End point description
    Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value. Intent-to-Treat (ITT) Population: all participants randomized to study drug who had at least one on-treatment FEV1.
    End point type
    Primary
    End point timeframe
    Baseline and Week 1 through Week 52
    End point values
    		 FSC DISKUS 250/50 mcg BID FP DISKUS 250 mcg BID for 52 weeks
    Number of subjects analysed
    303 [1]
    304 [2]
    Units: Liters
        arithmetic mean (standard error)
    0.16 ( 0.017 )
    0.12 ( 0.02 )
    Notes
    [1] - Intent-to-Treat (ITT) Population
    [2] - Intent-to-Treat (ITT) Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FSC DISKUS 250/50 mcg BID v FP DISKUS 250 mcg BID for 52 weeks
    Number of subjects included in analysis
    607
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.09
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.09

    Secondary: Mean change from baseline in AM PEF over Weeks 1-52

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    End point title
    		 Mean change from baseline in AM PEF over Weeks 1-52
    End point description
    Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 1 through Week 52
    End point values
    		 FSC DISKUS 250/50 mcg BID FP DISKUS 250 mcg BID for 52 weeks
    Number of subjects analysed
    305 [3]
    310 [4]
    Units: Liters/minute (L/min)
        arithmetic mean (standard error)
    27.7 ( 2.85 )
    14.6 ( 2.49 )
    Notes
    [3] - Participants in the ITT Population who had a minimum of 1 week PEF values.
    [4] - Participants in the ITT Population who had a minimum of 1 week PEF values.
    No statistical analyses for this end point

    Secondary: Mean change from baseline in the percentage of symptom-free days over Weeks 1-52

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    End point title
    		 Mean change from baseline in the percentage of symptom-free days over Weeks 1-52
    End point description
    A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 1 through Week 52
    End point values
    		 FSC DISKUS 250/50 mcg BID FP DISKUS 250 mcg BID for 52 weeks
    Number of subjects analysed
    305 [5]
    310 [6]
    Units: Percentage of symptom-free days
        arithmetic mean (standard error)
    37.4 ( 2.03 )
    28.9 ( 1.82 )
    Notes
    [5] - Participants in the ITT Population for which at least 1 week of diary data were provided.
    [6] - Participants in the ITT Population for which at least 1 week of diary data were provided.
    No statistical analyses for this end point

    Secondary: Rate of asthma attacks per participant per year

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    End point title
    		 Rate of asthma attacks per participant per year
    End point description
    The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a >=20% decrease in AM PEF, a >=70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.
    End point type
    Secondary
    End point timeframe
    Week 1 through Week 52
    End point values
    		 FSC DISKUS 250/50 mcg BID FP DISKUS 250 mcg BID for 52 weeks
    Number of subjects analysed
    310 [7]
    318 [8]
    Units: attacks per participant per year
        arithmetic mean (confidence interval 95%)
    2.63 (2.17 to 3.19)
    2.73 (2.26 to 3.31)
    Notes
    [7] - ITT Population
    [8] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All on-treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of the run-in period (Day -14 to -21) until the end of the follow up period (approximately 53 weeks).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    FP DISKUS 250 mcg BID for 52 weeks
    Reporting group description
    		 Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks

    Reporting group title
    FSC DISKUS 250/50 mcg BID
    Reporting group description
    		 Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks

    Serious adverse events
    		 FP DISKUS 250 mcg BID for 52 weeks FSC DISKUS 250/50 mcg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 318 (2.20%)
    6 / 310 (1.94%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Large intestine perforation
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast cancer
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 310 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cholecystitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 310 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FP DISKUS 250 mcg BID for 52 weeks FSC DISKUS 250/50 mcg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    201 / 318 (63.21%)
    184 / 310 (59.35%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    60 / 318 (18.87%)
    51 / 310 (16.45%)
         occurrences all number
    188
    153
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    18 / 318 (5.66%)
    19 / 310 (6.13%)
         occurrences all number
    21
    21
    Oropharyngeal pain
         subjects affected / exposed
    19 / 318 (5.97%)
    23 / 310 (7.42%)
         occurrences all number
    21
    28
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    24 / 318 (7.55%)
    23 / 310 (7.42%)
         occurrences all number
    33
    28
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    55 / 318 (17.30%)
    45 / 310 (14.52%)
         occurrences all number
    77
    60
    Nasopharyngitis
         subjects affected / exposed
    70 / 318 (22.01%)
    54 / 310 (17.42%)
         occurrences all number
    108
    75
    Bronchitis
         subjects affected / exposed
    38 / 318 (11.95%)
    34 / 310 (10.97%)
         occurrences all number
    61
    43
    Influenza
         subjects affected / exposed
    21 / 318 (6.60%)
    15 / 310 (4.84%)
         occurrences all number
    22
    15
    Sinusitis
         subjects affected / exposed
    40 / 318 (12.58%)
    33 / 310 (10.65%)
         occurrences all number
    45
    47
    Rhinitis
         subjects affected / exposed
    18 / 318 (5.66%)
    23 / 310 (7.42%)
         occurrences all number
    35
    39

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2007
    Amendment provided clarifications for the following: 1. Definition of “7 days prior to randomization” for the randomization criteria 2. Asthma Medication History inclusion criterion 3. Respiratory Tract Infections and Concurrent Medications exclusion criteria 4. Asthma Withdrawal criteria 5. Permitted and prohibited medications 6. Re-screening and screen failures 7. Calculation of percent predicted FEV1 8. Treatment for an asthma exacerbation and additional guidelines

    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
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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