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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
    		 2015-004892-61
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 May 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
    ADA109055
    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
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK 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
    15 Jul 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    TBD
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 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: 123
    Country: Number of subjects enrolled
    Brazil: 38
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    Philippines: 99
    Country: Number of subjects enrolled
    United States: 654
    Worldwide total number of subjects
    937
    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)
    147
    Adults (18-64 years)
    756
    From 65 to 84 years
    33
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 937 subjects were screened for this study; 316 (34%) failed screening and were not randomized to double-blind treatment. The majority (82%) of Screen Failures were unable to fulfill the study eligibility criteria.

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

    Investigational medicinal product name
    Fluticasone propionate/Salmeterol xinofoate 250/50 microgram (mcg) fixed dose combination (FDC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    FSC 250/50 mcg one inhalation twice daily (in the morning, and in the evening, approximately 12 hours apart)

    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 250 mcg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    FP 250 mcg one inhalation twice daily (in the morning, and in the evening, approximately 12 hours apart)

    Number of subjects in period 1 [1]
    		FSC DISKUS 250/50 mcg BID for 52 weeks FP DISKUS 250 mcg BID for 52 weeks
    Started
    306
    315
    Completed
    225
    242
    Not completed
    81
    73
         Consent withdrawn by subject
    26
    25
         Adverse event, non-fatal
    10
    3
         Other
    12
    7
         Lost to follow-up
    6
    9
         Lack of efficacy
    6
    4
         Protocol deviation
    21
    25
    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 937 subjects were screened for this study; 316 (34%) failed screening and were not randomized to double-blind treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FSC DISKUS 250/50 mcg BID for 52 weeks
    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 for 52 weeks FP DISKUS 250 mcg BID for 52 weeks Total
    Number of subjects
    		 306 315
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 36.8 ± 15.52 39.3 ± 15.52 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 191 201 392
        Male
    		 115 114 229
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 197 208 405
        African American
    		 63 61 124
        Asian
    		 39 41 80
        American Indian
    		 3 4 7
        Other
    		 4 1 5

    End points

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    End points reporting groups
    Reporting group title
    FSC DISKUS 250/50 mcg BID for 52 weeks
    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 by forced expiratory volume in one second (FEV1) over Weeks 1-52

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    End point title
    		 Mean change from baseline in pre-dose by forced expiratory volume in one second (FEV1) over Weeks 1-52
    End point description
    Pulmonary function was measured by 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.
    End point type
    Primary
    End point timeframe
    Baseline and Week 1 through Week 52
    End point values
    		 FSC DISKUS 250/50 mcg BID for 52 weeks FP DISKUS 250 mcg BID for 52 weeks
    Number of subjects analysed
    306 [1]
    315 [2]
    Units: Liters
        arithmetic mean (standard error)
    0.2 ± 0.017
    0.09 ± 0.015
    Notes
    [1] - Intent-to-Treat (ITT) Population: all participants randomized to study drug.
    [2] - Intent-to-Treat (ITT) Population: all participants randomized to study drug.
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    FP DISKUS 250 mcg BID for 52 weeks v FSC DISKUS 250/50 mcg BID for 52 weeks
    Number of subjects included in analysis
    621
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 0.15

    Secondary: Mean change from baseline in Morning (AM) peak expiratory flow (PEF) over Weeks 1-52

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    End point title
    		 Mean change from baseline in Morning (AM) peak expiratory flow (PEF) over Weeks 1-52
    End point description
    Morning 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 for 52 weeks FP DISKUS 250 mcg BID for 52 weeks
    Number of subjects analysed
    299 [3]
    313 [4]
    Units: Liters/minute (L/min)
        arithmetic mean (standard error)
    23.6 ± 2.47
    9.8 ± 2.4
    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 for 52 weeks FP DISKUS 250 mcg BID for 52 weeks
    Number of subjects analysed
    299 [5]
    313 [6]
    Units: Percentage of symptom-free days
        arithmetic mean (standard error)
    37.1 ± 2.02
    28.5 ± 1.9
    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 for 52 weeks FP DISKUS 250 mcg BID for 52 weeks
    Number of subjects analysed
    306 [7]
    315 [8]
    Units: attacks per participant per year
        arithmetic mean (confidence interval 95%)
    1.87 (1.36 to 2.59)
    2.14 (1.55 to 2.96)
    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 AE data from the time of subject consent until the follow-up period (approximately 53 weeks) were collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    FSC DISKUS 250/50 mcg BID for 52 weeks
    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

    Serious adverse events
    		 FSC DISKUS 250/50 mcg BID for 52 weeks FP DISKUS 250 mcg BID for 52 weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 306 (4.58%)
    9 / 315 (2.86%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Post procedural complication
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 306 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 306 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 306 (0.00%)
    1 / 315 (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
    Cerebrovascular accident
         subjects affected / exposed
    0 / 306 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    0 / 306 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 306 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 306 (0.98%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 306 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 306 (0.65%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (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
    0 / 306 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 306 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 306 (0.33%)
    0 / 315 (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
    		 FSC DISKUS 250/50 mcg BID for 52 weeks FP DISKUS 250 mcg BID for 52 weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    183 / 306 (59.80%)
    203 / 315 (64.44%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    56 / 306 (18.30%)
    59 / 315 (18.73%)
         occurrences all number
    158
    128
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    27 / 306 (8.82%)
    19 / 315 (6.03%)
         occurrences all number
    32
    24
    Oropharyngeal Pain
         subjects affected / exposed
    14 / 306 (4.58%)
    20 / 315 (6.35%)
         occurrences all number
    15
    23
    Rhinitis Allergic
         subjects affected / exposed
    13 / 306 (4.25%)
    18 / 315 (5.71%)
         occurrences all number
    17
    27
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    20 / 306 (6.54%)
    14 / 315 (4.44%)
         occurrences all number
    52
    17
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    62 / 306 (20.26%)
    96 / 315 (30.48%)
         occurrences all number
    89
    135
    Nasopharyngitis
         subjects affected / exposed
    54 / 306 (17.65%)
    56 / 315 (17.78%)
         occurrences all number
    87
    83
    Bronchitis
         subjects affected / exposed
    20 / 306 (6.54%)
    31 / 315 (9.84%)
         occurrences all number
    21
    35
    Influenza
         subjects affected / exposed
    22 / 306 (7.19%)
    25 / 315 (7.94%)
         occurrences all number
    24
    27
    Sinusitis
         subjects affected / exposed
    17 / 306 (5.56%)
    27 / 315 (8.57%)
         occurrences all number
    22
    38

    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: • Definition of “7 days prior to randomization” for the randomization criteria • Asthma Medication History inclusion criterion • Respiratory Tract Infections and Concurrent Medications exclusion criteria • Asthma Withdrawal criteria • Permitted and prohibited medications • Re-screening and screen failures • Calculation of percent predicted FEV1 • 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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