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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone

    Summary
    EudraCT number
    		 2015-004864-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Apr 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Sep 2016
    First version publication date
    25 Sep 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SFA103153
    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
    11 Jul 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to demonstrate that fluticasone propionate/ salmeterol 100/50mcg DISKUS BID (FSC 100/50) was superior to fluticasone propionate 100mcg DISKUS BID (FP 100) in controlling the asthma exacerbation rate in subjects of African descent with persistent asthma.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Nov 2004
    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 States: 523
    Worldwide total number of subjects
    523
    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)
    114
    Adults (18-64 years)
    409
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with persistent asthma, who were symptomatic while taking an inhaled corticosteroid (ICS) were entered a 2-week screening period. Participants completed the open-label Fluticasone propionate (FP) 250 microgram (mcg) run-in period were eligible to enter the double-blind treatment period.

    Pre-assignment
    Screening details
    		 A total of 865 participants were enrolled, of these, 342 were screen failures and 523 entered the Run-in period. Total 48 participants were run-in failures and 475 completed the Run-in period. Total 475 participants who were randomized into the study and received treatment were included in the Intent-to-Treat (ITT) Population.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluticasone propionate/salmeterol 100/50 mcg
    Arm description
    		 Participants self administered one inhalation of Fluticasone propionate/salmeterol 100/50 mcg via dry powder inhaler (DPI) twice daily, morning and evening 12 hours apart for 52 weeks treatment period. Participants were provided albuterol inhalation aerosol for relief of asthma symptoms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSC 100/50 mcg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants self administered one inhalation twice daily, approximately 12 hours apart, in morning and evening via dry powder inhaler for the treatment duration of 52 weeks.

    Arm title
    		 Fluticasone propionate 100 mcg
    Arm description
    		 Participants self administered one inhalation of Fluticasone propionate (FP) 100 mcg via DPI twice daily, morning and evening 12 hours apart for 52 weeks treatment period. Participants were provided albuterol inhalation aerosol for relief of asthma symptoms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FP 100 mcg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants self administered one inhalation twice daily, approximately 12 hours apart, in morning and evening via dry powder inhaler for the treatment duration of 52 weeks.

    Number of subjects in period 1 [1]
    		Fluticasone propionate/salmeterol 100/50 mcg Fluticasone propionate 100 mcg
    Started
    239
    236
    Completed
    169
    151
    Not completed
    70
    85
         Lack of Efficacy
    1
    1
         Dropped by GSK
    -
    1
         Consent withdrawn by subject
    16
    18
         Too many days between visits
    -
    1
         Adverse event, non-fatal
    5
    6
         Exacerbation
    6
    9
         No Medicines taken
    1
    -
         Non-compliance
    10
    19
         Moving out of the Area
    1
    -
         Lost to follow-up
    19
    13
         Subject Withdrew Consent Due to Moving
    -
    1
         Elective Surgery
    1
    -
         Pregnancy
    6
    5
         Moved out of the state
    1
    1
         Protocol deviation
    3
    10
    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 523 participants entered the Run-in period; however, 48 participants were run-in failures so only 475 participants completed the Run-in period and were randomized into the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluticasone propionate/salmeterol 100/50 mcg
    Reporting group description
    		 Participants self administered one inhalation of Fluticasone propionate/salmeterol 100/50 mcg via dry powder inhaler (DPI) twice daily, morning and evening 12 hours apart for 52 weeks treatment period. Participants were provided albuterol inhalation aerosol for relief of asthma symptoms.

    Reporting group title
    Fluticasone propionate 100 mcg
    Reporting group description
    		 Participants self administered one inhalation of Fluticasone propionate (FP) 100 mcg via DPI twice daily, morning and evening 12 hours apart for 52 weeks treatment period. Participants were provided albuterol inhalation aerosol for relief of asthma symptoms.

    Reporting group values
    		 Fluticasone propionate/salmeterol 100/50 mcg Fluticasone propionate 100 mcg Total
    Number of subjects
    		 239 236 475
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.5 ( 13.48 ) 32.2 ( 13.57 ) -
    Gender categorical
    Units: Subjects
        Female
    		 143 150 293
        Male
    		 96 86 182
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 233 231 464
        Mixed race
    		 6 5 11

    End points

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    End points reporting groups
    Reporting group title
    Fluticasone propionate/salmeterol 100/50 mcg
    Reporting group description
    		 Participants self administered one inhalation of Fluticasone propionate/salmeterol 100/50 mcg via dry powder inhaler (DPI) twice daily, morning and evening 12 hours apart for 52 weeks treatment period. Participants were provided albuterol inhalation aerosol for relief of asthma symptoms.

    Reporting group title
    Fluticasone propionate 100 mcg
    Reporting group description
    		 Participants self administered one inhalation of Fluticasone propionate (FP) 100 mcg via DPI twice daily, morning and evening 12 hours apart for 52 weeks treatment period. Participants were provided albuterol inhalation aerosol for relief of asthma symptoms.

    Primary: Asthma exacerbation rate per patient per year

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    End point title
    		 Asthma exacerbation rate per patient per year
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline (Week 0) up to Week 52
    End point values
    		 Fluticasone propionate/salmeterol 100/50 mcg Fluticasone propionate 100 mcg
    Number of subjects analysed
    239 [1]
    236 [2]
    Units: Rate of exacerbations per year
        arithmetic mean (standard error)
    0.449 ( 0.0926 )
    0.529 ( 0.0916 )
    Notes
    [1] - ITT Population comprised of all participants randomized to study drug
    [2] - ITT Population comprised of all participants randomized to study drug
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone propionate/salmeterol 100/50 mcg v Fluticasone propionate 100 mcg
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.169
    Method
    		 Poisson regression
    Confidence interval

    Secondary: Mean change from baseline morning (AM) peak expiratory flow (PEF)

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    End point title
    		 Mean change from baseline morning (AM) peak expiratory flow (PEF)
    End point description
    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 52-week Treatment Period minus the Baseline value. Baseline values (Week 0) were derived from pre-treatment measurements. Baseline was defined as the mean value over the day of randomization plus the six preceeding days. Statistical analysis was performed using an analysis of covariance (ANCOVA) model. Participants analyzed included those who have PEF data.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) up to Week 52
    End point values
    		 Fluticasone propionate/salmeterol 100/50 mcg Fluticasone propionate 100 mcg
    Number of subjects analysed
    221 [3]
    216 [4]
    Units: Liter/minute
        arithmetic mean (standard error)
    15.6 ( 3.48 )
    1.4 ( 3.42 )
    Notes
    [3] - ITT Population. Participants analyzed included those who have PEF data.
    [4] - ITT Population. Participants analyzed included those who have PEF data.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone propionate/salmeterol 100/50 mcg v Fluticasone propionate 100 mcg
    Number of subjects included in analysis
    437
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.5
         upper limit
    		 24.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.89

    Secondary: Mean change from baseline in morning pre-dose clinic forced expiratory volume in one second (FEV1)

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    End point title
    		 Mean change from baseline in morning pre-dose clinic forced expiratory volume in one second (FEV1)
    End point description
    FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. FEV1 was measured each morning prior to the dose of study medication by spirometry. Change from Baseline was calculated as the value of the averaged daily FEV1 over the 52-week Treatment Period minus the Baseline value. Baseline values (Week 0) were derived from pre-treatment measurements. Statistical analysis was performed using ANCOVA model. Participants analyzed included those who have FEV1 data.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) up to Week 52
    End point values
    		 Fluticasone propionate/salmeterol 100/50 mcg Fluticasone propionate 100 mcg
    Number of subjects analysed
    233 [5]
    226 [6]
    Units: Liter
        arithmetic mean (standard error)
    0.045 ( 0.0234 )
    -0.061 ( 0.0211 )
    Notes
    [5] - ITT Population. Participants analyzed included those who have FEV1 data.
    [6] - ITT Population. Participants analyzed included those who have FEV1 data.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone propionate 100 mcg v Fluticasone propionate/salmeterol 100/50 mcg
    Number of subjects included in analysis
    459
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.103
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.041
         upper limit
    		 0.165
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0317

    Secondary: Mean change from baseline in symptom-free days

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    End point title
    		 Mean change from baseline in symptom-free days
    End point description
    Symptom-free days are number of days that a participant goes without asthma symptoms over the 52-week Treatment Period. Percent change from Baseline was calculated as the value of the averaged daily Symptom-free days over the 52-week Treatment Period minus the Baseline value multiplied by 100. Baseline values (Week 0) were derived from pre-treatment measurements. Statistical analysis was performed using ANCOVA model. Participants analyzed included those who have Symptom-free days data.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) up to Week 52
    End point values
    		 Fluticasone propionate/salmeterol 100/50 mcg Fluticasone propionate 100 mcg
    Number of subjects analysed
    218 [7]
    214 [8]
    Units: Days
        arithmetic mean (standard error)
    10.8 ( 2.46 )
    8.9 ( 2.21 )
    Notes
    [7] - ITT Population. Participants analyzed included those who have Symptom-free days data.
    [8] - ITT Population. Participants analyzed included those who have Symptom-free days data.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone propionate/salmeterol 100/50 mcg v Fluticasone propionate 100 mcg
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.296
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 9.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.2

    Secondary: Mean change from baseline in albuterol-free days

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    End point title
    		 Mean change from baseline in albuterol-free days
    End point description
    Albuterol-free days were days when Albuterol use was unnecessary based on daily record and symptom free days. Percent change from Baseline was calculated as the value of the averaged daily albuterol-free days over the 52-week Treatment Period minus the Baseline value multiplied by 100. Baseline values (Week 0) were derived from pre-treatment measurements. Statistical analysis was performed using ANCOVA model. Participants analyzed included those who have albuterol-free days data.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0) up to Week 52
    End point values
    		 Fluticasone propionate/salmeterol 100/50 mcg Fluticasone propionate 100 mcg
    Number of subjects analysed
    216 [9]
    211 [10]
    Units: Days
        arithmetic mean (standard error)
    10.8 ( 2.5 )
    5.6 ( 2.54 )
    Notes
    [9] - ITT Population. Participants analyzed included those who have albuterol-free days data.
    [10] - ITT Population. Participants analyzed included those who have albuterol-free days data.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fluticasone propionate/salmeterol 100/50 mcg v Fluticasone propionate 100 mcg
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.159
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 10.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.22

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP (Week 0) until Week 52 for double blind treatment period.
    Adverse event reporting additional description
    On-treatment SAEs and non-serious AEs are reported for ITT Population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Fluticasone propionate/salmeterol 100/50 mcg
    Reporting group description
    		 Participants self administered one inhalation of Fluticasone propionate/salmeterol 100/50 mcg via dry powder inhaler (DPI) twice daily, morning and evening 12 hours apart for 52 weeks treatment period. Participants were provided albuterol inhalation aerosol for relief of asthma symptoms.

    Reporting group title
    Fluticasone propionate 100 mcg
    Reporting group description
    		 Participants self administered one inhalation of Fluticasone propionate (FP) 100 mcg via DPI twice daily, morning and evening 12 hours apart for 52 weeks treatment period. Participants were provided albuterol inhalation aerosol for relief of asthma symptoms.

    Serious adverse events
    		 Fluticasone propionate/salmeterol 100/50 mcg Fluticasone propionate 100 mcg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 239 (2.51%)
    11 / 236 (4.66%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 236 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arteriospasm coronary
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 236 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 236 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 236 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         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
    Respiratory distress
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 239 (0.84%)
    2 / 236 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis infective
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 236 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus non-insulin-dependent
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 236 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Fluticasone propionate/salmeterol 100/50 mcg Fluticasone propionate 100 mcg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    118 / 239 (49.37%)
    130 / 236 (55.08%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    34 / 239 (14.23%)
    41 / 236 (17.37%)
         occurrences all number
    192
    144
    Sinus headache
         subjects affected / exposed
    5 / 239 (2.09%)
    8 / 236 (3.39%)
         occurrences all number
    6
    14
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    4 / 239 (1.67%)
    9 / 236 (3.81%)
         occurrences all number
    7
    9
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    13 / 239 (5.44%)
    8 / 236 (3.39%)
         occurrences all number
    20
    11
    Abdominal pain upper
         subjects affected / exposed
    12 / 239 (5.02%)
    7 / 236 (2.97%)
         occurrences all number
    16
    14
    Nausea
         subjects affected / exposed
    9 / 239 (3.77%)
    7 / 236 (2.97%)
         occurrences all number
    10
    7
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal pain
         subjects affected / exposed
    20 / 239 (8.37%)
    17 / 236 (7.20%)
         occurrences all number
    25
    28
    Cough
         subjects affected / exposed
    15 / 239 (6.28%)
    17 / 236 (7.20%)
         occurrences all number
    19
    27
    Rhinitis allergic
         subjects affected / exposed
    10 / 239 (4.18%)
    2 / 236 (0.85%)
         occurrences all number
    32
    3
    Sinus congestion
         subjects affected / exposed
    7 / 239 (2.93%)
    9 / 236 (3.81%)
         occurrences all number
    13
    14
    Nasal congestion
         subjects affected / exposed
    9 / 239 (3.77%)
    6 / 236 (2.54%)
         occurrences all number
    11
    6
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    11 / 239 (4.60%)
    21 / 236 (8.90%)
         occurrences all number
    20
    25
    Arthralgia
         subjects affected / exposed
    10 / 239 (4.18%)
    6 / 236 (2.54%)
         occurrences all number
    12
    8
    Neck pain
         subjects affected / exposed
    3 / 239 (1.26%)
    8 / 236 (3.39%)
         occurrences all number
    3
    10
    Myalgia
         subjects affected / exposed
    9 / 239 (3.77%)
    3 / 236 (1.27%)
         occurrences all number
    9
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    18 / 239 (7.53%)
    41 / 236 (17.37%)
         occurrences all number
    33
    53
    Upper respiratory tract infection
         subjects affected / exposed
    32 / 239 (13.39%)
    32 / 236 (13.56%)
         occurrences all number
    42
    44
    Sinusitis
         subjects affected / exposed
    17 / 239 (7.11%)
    27 / 236 (11.44%)
         occurrences all number
    22
    32
    Bronchitis
         subjects affected / exposed
    6 / 239 (2.51%)
    12 / 236 (5.08%)
         occurrences all number
    7
    12
    Influenza
         subjects affected / exposed
    9 / 239 (3.77%)
    4 / 236 (1.69%)
         occurrences all number
    12
    4
    Gastroenteritis viral
         subjects affected / exposed
    6 / 239 (2.51%)
    9 / 236 (3.81%)
         occurrences all number
    6
    9

    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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    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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