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    Clinical Trial Results:
    Clinical assessment of GW815SF Salmeterol/fluticasone propionate (HFA MDI) in pediatric patients with bronchial asthma -A long term (24-week) study

    Summary
    EudraCT number
    		 2015-004881-27
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Nov 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    110101
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Feb 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2007
    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
    30 Mar 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
    Japan: 40
    Worldwide total number of subjects
    40
    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)
    35
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 40
    Number of subjects completed
    		 40

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

    Arms
    Arm title
    		 Salmeterol/fluticasone propionate
    Arm description
    		 Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salmeterol/fluticasone propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Oral use
    Dosage and administration details
    Two inhalations twice daily

    Number of subjects in period 1
    		Salmeterol/fluticasone propionate
    Started
    40
    Completed
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Salmeterol/fluticasone propionate
    Reporting group description
    		 Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)

    Reporting group values
    		 Salmeterol/fluticasone propionate Total
    Number of subjects
    		 40
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 8.7 ( 2.5 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 16 16
        Male
    		 24 24
    Race/Ethnicity, Customized
    One participant counted twice due to having multiple races.
    Units: Subjects
        Asian
    		 40 40

    End points

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    End points reporting groups
    Reporting group title
    Salmeterol/fluticasone propionate
    Reporting group description
    		 Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)

    Primary: Most Frequent Adverse Events - On Therapy

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    End point title
    		 Most Frequent Adverse Events - On Therapy [1]
    End point description
    Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    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: There are no statistical data to report.
    End point values
    		 Salmeterol/fluticasone propionate
    Number of subjects analysed
    40 [2]
    Units: Participants
        Laryngopharyngitis
    8
        Bronchitis
    8
        Nasopharyngitis
    8
        Asthma
    8
        Pharyngitis
    6
        Pyrexia
    5
        Otitis media
    4
        Pharyngotonsillitis
    3
        Laryngotracheo bronchitis
    3
        Molluscum contagiosum
    3
        Stomatitis
    3
    Notes
    [2] - Safety analysis was performed on the primary outcome measures, adverse events and safety population
    No statistical analyses for this end point

    Primary: Serious Adverse Events (SAEs) - On Therapy

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    End point title
    		 Serious Adverse Events (SAEs) - On Therapy [3]
    End point description
    Number of participants considered by the investigator to be related to study medication. Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    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: There are no statistical data to report.
    End point values
    		 Salmeterol/fluticasone propionate
    Number of subjects analysed
    40 [4]
    Units: Participants
    1
    Notes
    [4] - Safety population, all who entered treatment period and received at least 1 dose of study med
    No statistical analyses for this end point

    Secondary: Change from Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24

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    End point title
    		 Change from Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
    End point description
    PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
    End point type
    Secondary
    End point timeframe
    Baseline and during Weeks 1-24
    End point values
    		 Salmeterol/fluticasone propionate
    Number of subjects analysed
    40 [5]
    Units: L/min
        arithmetic mean (standard deviation)
    32.9 ( 34.48 )
    Notes
    [5] - Efficacy analyses were performed on the secondary outcome measures and Full analysis set
    No statistical analyses for this end point

    Secondary: Change from Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24

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    End point title
    		 Change from Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
    End point description
    Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.
    End point type
    Secondary
    End point timeframe
    Baseline and during Weeks 1-24
    End point values
    		 Salmeterol/fluticasone propionate
    Number of subjects analysed
    40 [6]
    Units: Percent Change
        arithmetic mean (standard deviation)
    12.5 ( 11.294 )
    Notes
    [6] - Efficacy analyses were performed on the secondary outcome measures and Full analysis set
    No statistical analyses for this end point

    Secondary: Change from Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24

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    End point title
    		 Change from Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
    End point description
    The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
    End point type
    Secondary
    End point timeframe
    Baseline and during Weeks 1-24
    End point values
    		 Salmeterol/fluticasone propionate
    Number of subjects analysed
    40 [7]
    Units: L/min
        arithmetic mean (standard deviation)
    31.2 ( 29.28 )
    Notes
    [7] - Efficacy analyses were performed on the secondary outcome measures and Full analysis set
    No statistical analyses for this end point

    Secondary: Change from Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24

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    End point title
    		 Change from Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24
    End point description
    Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
    End point type
    Secondary
    End point timeframe
    Baseline and during Weeks 1-24
    End point values
    		 Salmeterol/fluticasone propionate
    Number of subjects analysed
    40 [8]
    Units: Percent Change
        arithmetic mean (standard deviation)
    -1.62 ( 3.583 )
    Notes
    [8] - Efficacy analyses were performed on the secondary outcome measures and Full analysis set
    No statistical analyses for this end point

    Secondary: Number of Participants with Symptom-Free Nights and Days

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    End point title
    		 Number of Participants with Symptom-Free Nights and Days
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Salmeterol/fluticasone propionate
    Number of subjects analysed
    40 [9]
    Units: Participants
        Baseline
    29
        Week 24
    31
    Notes
    [9] - Efficacy analyses were performed on the secondary outcome measures and Full analysis set
    No statistical analyses for this end point

    Secondary: Number of Participants with Rescue Medication-Free Nights and Days

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    End point title
    		 Number of Participants with Rescue Medication-Free Nights and Days
    End point description
    Rescue free means without the use of other medication.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Salmeterol/fluticasone propionate
    Number of subjects analysed
    40 [10]
    Units: Participants
        Baseline
    33
        Week 24
    32
    Notes
    [10] - Efficacy analyses were performed on the secondary outcome measures and Full analysis set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs were monitored throughout the 24 weeks of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Salmeterol/fluticasone propionate
    Reporting group description
    		 Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)

    Serious adverse events
    		 Salmeterol/fluticasone propionate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 40 (2.50%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Salmeterol/fluticasone propionate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 40 (87.50%)
    General disorders and administration site conditions
    Pyrexia
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    5
    Gastrointestinal disorders
    Abdominal pain
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Acetonaemic vomiting
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Stomatitis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    13
    Skin and subcutaneous tissue disorders
    Eczema
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Heat Rash
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    8
    Gastroenteritis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Laryngopharyngitis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    17
    Laryngotracheo bronchitis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    4
    Molluscum contagiosum
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    4
    Nasopharyngitis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    14
    Otitis Media
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Pharyngitis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    7
    Pharyngotonsillitis
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Sinusitus
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    tonsillitus
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    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
    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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