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    Clinical Trial Results:
    A randomized, double-blind, double-dummy, parallel group study evaluating the safety of fluticasone propionate/salmeterol 100/50mcg HFA (2 inhalations of 50/25mcg) twice daily compared with fluticasone propionate 100mcg HFA (2 inhalations of 50mcg) twice daily in subjects 4-11 years of age with persistent asthma.

    Summary
    EudraCT number
    		 2006-001417-16
    Trial protocol
    		 DE   LT   LV   ES  
    Global end of trial date
    28 Jan 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Apr 2016
    First version publication date
    05 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SFA106484
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00441441
    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 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, +1 8664357343,
    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
    28 Jan 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the safety of fluticasone propionate/salmeterol 100/50mcg HFA twice daily compared with fluticasone propionate 100mcg HFA twice daily in subjects 4-11 years of age with persistent asthma
    Protection of trial subjects
    The study procedures were not expected to present any pain, distress or discomfort to study participants. The therapeutic intervention were Fluticasone propionate/salmeterol HFA (50/25mcg per actuation (ex-valve) 45/21mcg per actuation (ex-actuator)) or Fluticasone propionate HFA (50mcg per actuation (exvalve) 44mcg per actuation (exactuator)). Information pertaining to study procedures was disclosed in the informed consent form presented to each prospective study subject, required reviewed and subject’s signature, prior to study articipation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Feb 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
    Canada: 23
    Country: Number of subjects enrolled
    Chile: 54
    Country: Number of subjects enrolled
    Costa Rica: 24
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    Latvia: 2
    Country: Number of subjects enrolled
    Lithuania: 13
    Country: Number of subjects enrolled
    Mexico: 27
    Country: Number of subjects enrolled
    Peru: 27
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Russian Federation: 29
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United States: 98
    Worldwide total number of subjects
    351
    EEA total number of subjects
    69
    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)
    351
    Adolescents (12-17 years)
    0
    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
    		 A total of 351 participants were enrolled in the study. However, only 350 of these 351 participants comprised the Intent-to-Treat Population, defined as all participants who were randomly assigned to treatment and received >=1 dose of Double-Blind study treatment.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)
    Arm description
    		 Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (μg) HFA (2 inhalations of 50/25 μg), twice daily for 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone propionate/salmeterol HFA (50/25mcg per actuation (ex-valve) 45/21mcg per actuation (ex-actuator))
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Respiratory use
    Dosage and administration details
    Fluticasone propionate/salmeterol HFA (50/25mcg per actuation (ex-valve) 45/21mcg per actuation (ex-actuator)) - Metered Dose Inhaler

    Arm title
    		 Fluticasone Propionate Hydrofluoroalkane (HFA)
    Arm description
    		 Participants who were randomly assigned to Fluticasone Propionate 100 μg HFA (2 inhalations of 50 μg), twice daily for 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone propionate HFA (50mcg per actuation (ex-valve) 44mcg per actuation (ex-actuator))
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Respiratory use
    Dosage and administration details
    Fluticasone propionate HFA (50mcg per actuation (ex-valve) 44mcg per actuation (ex-actuator)) - Metered Dose Inhaler

    Number of subjects in period 1 [1]
    		Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Started
    173
    177
    Completed
    162
    163
    Not completed
    11
    14
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    2
    1
         Not specified
    3
    3
         Exacerbation of asthma
    1
    2
         Protocol deviation
    4
    6
    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 351 participants were enrolled in the study. However, only 350 of these 351 participants were randomized to receive treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)
    Reporting group description
    		 Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (μg) HFA (2 inhalations of 50/25 μg), twice daily for 12 weeks.

    Reporting group title
    Fluticasone Propionate Hydrofluoroalkane (HFA)
    Reporting group description
    		 Participants who were randomly assigned to Fluticasone Propionate 100 μg HFA (2 inhalations of 50 μg), twice daily for 12 weeks.

    Reporting group values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA) Total
    Number of subjects
    		 173 177 350
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.7 ± 2.1 7.6 ± 2.12 -
    Gender categorical
    Units: Subjects
        Female
    		 66 71 137
        Male
    		 107 106 213
    Race, Customized
    Units: Subjects
        White/Caucasian/European Heritage
    		 114 113 227
        American Indian or Alaska Native
    		 24 27 51
        Central/South Asian Heritage
    		 8 8 16
        African American/African Heritage
    		 7 8 15
        Japanese Heritage
    		 3 0 3
        Arabic/North African Heritage
    		 2 2 4
        South East Asian Heritage
    		 2 0 2
        Mixed Race
    		 13 19 32
    Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 70 73 143
        Not Hispanic or Latino
    		 103 104 207

    End points

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    End points reporting groups
    Reporting group title
    Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)
    Reporting group description
    		 Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (μg) HFA (2 inhalations of 50/25 μg), twice daily for 12 weeks.

    Reporting group title
    Fluticasone Propionate Hydrofluoroalkane (HFA)
    Reporting group description
    		 Participants who were randomly assigned to Fluticasone Propionate 100 μg HFA (2 inhalations of 50 μg), twice daily for 12 weeks.

    Subject analysis set title
    Fluticasone Propionate/Salmeterol HFA
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (μg) HFA (2 inhalations of 50/25 μg), twice daily for 12 weeks. The Cortisol Population included all participants not excluded due to the following reasons: missing data, use of protocol-specified corticosteroids (prior to screening), collection time outside of 24 ± 2 hours, use of inhaled cortical steroid (ICS) during treatment, and who stopped study medication >1 day prior to start of postbaseline urine collection.

    Subject analysis set title
    Fluticasone Propionate HFA
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were randomly assigned to Fluticasone Propionate 100 μg HFA (2 inhalations of 50 μg), twice daily for 12 weeks. The Cortisol Population included all participants not excluded due to the following reasons: missing data, use of protocol-specified corticosteroids (prior to screening), collection time outside of 24 ± 2 hours, use of inhaled cortical steroid (ICS) during treatment, and who stopped study medication >1 day prior to start of postbaseline urine collection.

    Subject analysis set title
    Fluticasone Propionate/Salmeterol HFA - Spacer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Fluticasone propionate/salmeterol 100/50 micrograms (μg) HFA (2 inhalations of 50/25μg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers

    Subject analysis set title
    Fluticasone Propionate/Salmeterol HFA - No Spacer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Fluticasone propionate/salmeterol 100/50 μg HFA (2 inhalations of 50/25 μg) twice daily in participants 4-11 years of age for 12 weeks

    Subject analysis set title
    Fluticasone Propionate HFA - Spacer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Fluticasone Propionate 100 μg HFA (2 inhalation of 50 μg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers

    Subject analysis set title
    Fluticasone Propionate HFA - No Spacer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Fluticasone Propionate 100 μg HFA (2 inhalation of 50 μg) twice daily in participants 4-11 years of age for 12 weeks

    Subject analysis set title
    FP/S HFA or FP HFA - No Spacer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who did not use spacer and were in either treatment group of Fluticasone propionate/salmeterol 100/50 μg (FP/S) HFA (2 inhalations of 50/25 μg) or Fluticasone Propionate 100 μg (FP) HFA (2 inhalations of 50 μg) twice daily in participants 4-11 years of age for 12 weeks

    Subject analysis set title
    FP/S HFA or FP HFA - Spacer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who required a spacer and were in either treatment group of Fluticasone propionate/salmeterol 100/50 micrograms (μg) (FP/S) HFA (2 inhalations of 50/25 μg) or Fluticasone Propionate 100 μg (FP) HFA (2 inhalations of 50 μg) twice daily in participants 4-11 years of age for 12 weeks.

    Primary: Possible Drug-Related Adverse Events

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    End point title
    		 Possible Drug-Related Adverse Events [1]
    End point description
    Adverse Events reported by the Investigator and judged by the Investigator to be possibly related to study drug, categorized by the Medical Dictionary for Regulatory Activities (MeDRA), were reported. ECG, electrocardiogram. QTc (corrected QT interval) and QT represent intervals on an ECG. The Intent-to-Treat (ITT) Population was used which includes all participants who were randomized and received at least one dose of double-blind study treatment.
    End point type
    Primary
    End point timeframe
    Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)
    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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173
    177
    Units: Participants
    number (not applicable)
        Participants with any drug-related event
    13
    16
        Investigations - ECG QTc interval prolonged
    9
    4
        Investigations - QT interval prolonged
    0
    2
        Investigations - ECG QT borderline prolonged
    1
    0
        Investigations - ECG QT interval abnormal
    1
    0
        Cardiac - Defect conduction intraventricular
    2
    7
        Cardiac - Conduction disorder
    1
    1
        Cardiac - Sinus tachycardia
    1
    0
        Cardiac - Supraventricular ectopics
    0
    1
        Infections/Infestations - Oral candidiasis
    0
    1
        Infections/Infest - Oropharyngeal candidiasis
    0
    1
        Respiratory/thoracic/mediastinal - Dysphonia
    2
    0
    No statistical analyses for this end point

    Primary: Investigator Evaluations of Electrocardiogram (ECG) Results

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    End point title
    		 Investigator Evaluations of Electrocardiogram (ECG) Results [2]
    End point description
    ECGs were transmitted to an independent cardiologist who was responsible for providing interpretation of the ECG as either normal or abnormal (based on personal assessment). The investigator was then responsible for determining the clinical significance of the abnormal ECG in the context of the participants’ history and clinical presentation. An abnormal, clinically significant ECG included, but was not limited to: prolonged QT interval, ischemic changes, ventricular hypertrophy, intraventricular conduction abnormalities, and clinically significant arrhythmias. PD, premature discontinuation. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The number of participants at Week 12 was 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [2] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [3]
    177 [4]
    Units: participants
    number (not applicable)
        Baseline - Normal
    145
    155
        Baseline - Abnormal: Not Clinically Significant
    27
    21
        Baseline - Abnormal: Clinically Significant
    1
    0
        Week 12-No Change or insignificant Change
    136
    142
        Week 12-Clinically Significant Change-Favorable
    2
    0
        Week 12-Clinically Significant Change-Unfavorable
    24
    18
        PD-No Change or insignificant Change
    7
    9
        PD-Clinically Significant Change-Favorable
    0
    1
        PD-Clinically Significant Change-Unfavorable
    0
    1
    Notes
    [3] - ITT Population
    [4] - ITT Population
    No statistical analyses for this end point

    Primary: Clinically Significant Unfavorable ECGs at Week 12

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    End point title
    		 Clinically Significant Unfavorable ECGs at Week 12 [5]
    End point description
    Post-randomization ECGs categorized by the primary investigator as no change, significant change (favorable), significant change (unfavorable) from the ECG performed at Visit 1 (Baseline) are presented. Significant change (favorable) includes any ECG that improved from baseline, whereas significant change (unfavorable) includes any ECG that worsened from baseline. Clinical significance is determined by the primary investigator. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The numbers of participants at Week 12 were 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    Notes
    [5] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [6]
    177 [7]
    Units: participants
    number (not applicable)
        Clinically significant unfavorable change
    24
    18
        AEs Reported for ECG findings
    22
    18
        Clinically significant unfavorable ECGs repeated
    11
    11
        Repeated ECGs w/ no change or insignificant change
    6
    5
    Notes
    [6] - ITT Population
    [7] - ITT Population
    No statistical analyses for this end point

    Primary: ECG Measures - Heart Rate

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    End point title
    		 ECG Measures - Heart Rate [8]
    End point description
    The range of heart rates for this study was between 49-144 beats per minute
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [8] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [9]
    177 [10]
    Units: beats per minute
    arithmetic mean (full range (min-max))
        Mean Heart Rate - Baseline
    84 (53 to 144)
    82.6 (51 to 136)
        Mean Heart Rate - Week 12
    85.5 (59 to 138)
    81.9 (52 to 121)
        Mean Heart Rate - Premature Discontinuation
    73.1 (53 to 90)
    92.4 (49 to 130)
    Notes
    [9] - ITT Population
    [10] - ITT Population
    No statistical analyses for this end point

    Primary: ECG Measures - QT Interval

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    End point title
    		 ECG Measures - QT Interval [11]
    End point description
    Fridericia’s formula QTc interval=QT interval/cubed root of the R-R interval. The Bazett’s formula QTc=QT/squared root of the R-R interval.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [11] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [12]
    177 [13]
    Units: milliseconds
    arithmetic mean (full range (min-max))
        Mean QTc Interval (Fridericia)- Baseline
    394.5 (340 to 449)
    390.8 (338 to 429)
        Mean QTc Interval (Fridericia) - Week 12
    397.5 (355 to 439)
    393.6 (329 to 449)
        Premature Discontinuation (Fridericia)
    392 (359 to 417)
    394.8 (376 to 408)
        Mean QTc Interval (Bazett) - Baseline
    416.3 (356 to 464)
    411.4 (346 to 471)
        Mean QTc Interval (Bazett) - Week 12
    420.8 (368 to 466)
    413.7 (351 to 477)
        Premature Discontinuation (Bazett)
    403.3 (376 to 446)
    422.7 (378 to 454)
    Notes
    [12] - ITT Population
    [13] - ITT Population
    No statistical analyses for this end point

    Primary: Cardiovascular Adverse Events Reported During Treatment Period

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    End point title
    		 Cardiovascular Adverse Events Reported During Treatment Period [14]
    End point description
    Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Treatment Period. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event. Please see the category titles for a list of candidate cardiovascular adverse events.
    End point type
    Primary
    End point timeframe
    12-Week Treatment Period
    Notes
    [14] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [15]
    177 [16]
    Units: participants
    number (not applicable)
        Participants with Any Event
    98
    103
        Electrocardiogram (ECG) Change
    3
    2
        ECG QTc Interval Prolonged
    2
    1
        ECG Abnormal
    1
    1
        ECG QT Borderline Prolonged
    1
    0
        Defect Conduction Intraventricular
    4
    3
        Cardiac Arrhythmia
    1
    0
        Premature Atrial Contraction
    1
    0
    Notes
    [15] - ITT Population
    [16] - ITT Population
    No statistical analyses for this end point

    Primary: Cardiovascular Adverse Events Reported During the Post-Treatment Period

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    End point title
    		 Cardiovascular Adverse Events Reported During the Post-Treatment Period [17]
    End point description
    Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Post-treatment period, defined as 1 day after last dose of study drug. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event.
    End point type
    Primary
    End point timeframe
    5 Days after Week 12
    Notes
    [17] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [18]
    177 [19]
    Units: participants
    number (not applicable)
        Participants with Any Event
    19
    19
        ECG QTc interval prolonged
    11
    5
        QT interval prolonged
    1
    2
        ECG QT interval Abnormal
    1
    0
        Defect Conduction Intraventricular
    2
    7
        Conduction disorder
    1
    1
        Sinus Tachycardia
    1
    0
        Supraventricular Ectopics
    0
    1
    Notes
    [18] - ITT Population
    [19] - ITT Population
    No statistical analyses for this end point

    Primary: Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols

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    End point title
    		 Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols [20]
    End point description
    The Primary Investigator determined the severity of the exacerbation based on the participant’s clinical presentation and the investigator’s understanding of the disease, the participant, and his or her clinical experiences. The severity of the exacerbation was not defined in the protocol. Mild: Usually treated at home. Prompt relief with inhaled short-acting beta2 agonist. Possible short course of oral systemic corticosteroids. Moderate: Usually requires office or emergency department visit. Relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for 1-2 days after treatment begins. Severe: Usually requires emergency department visit and likely hospitalization. Partial relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for more than 3 days after treatment begins. Adjunctive therapies are helpful.
    End point type
    Primary
    End point timeframe
    Treatment period (weeks 1-12)
    Notes
    [20] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [21]
    177 [22]
    Units: participants
    number (not applicable)
        Participants with any asthma exacerbation
    1
    3
        Severity - Mild
    1
    2
        Severity - Moderate/Severe
    0
    1
        Withdrawal due to Asthma Exacerbation
    1
    2
    Notes
    [21] - ITT Population
    [22] - ITT Population
    No statistical analyses for this end point

    Primary: Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion

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    End point title
    		 Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion [23]
    End point description
    "Abnormal high cortisol excretion" and "Abnormal low cortisol excretion" are defined as above the upper limit of normal and below the lower limit of normal, respectively. The normal range for cortisol levels vary by age and gender. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory. The Cortisol Population was used which included all participants not excluded due to the following reasons: missing data, use of protocol-specified corticosteroids (prior to screening), collection time outside of 24 ± 2 hours, use of inhaled cortical steroid (ICS) during treatment, and who stopped study medication >1 day prior to start of postbaseline urine collection.
    End point type
    Primary
    End point timeframe
    Baseline and week 12
    Notes
    [23] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol HFA Fluticasone Propionate HFA
    Number of subjects analysed
    147 [24]
    144 [25]
    Units: participants
    number (not applicable)
        Baseline - Abnormal high cortisol excretion, n
    13
    17
        Baseline - Abnormal low cortisol excretion, n
    1
    0
        Week 12 - Abnormal high cortisol excretion, n
    13
    8
        Week 12 - Abnormal low cortisol excretion, n
    2
    0
    Notes
    [24] - Cortisol Population
    [25] - Cortisol Population
    No statistical analyses for this end point

    Primary: Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12

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    End point title
    		 Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12 [26]
    End point description
    Normal range for Cortisol levels vary by age and gender. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [26] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol HFA Fluticasone Propionate HFA
    Number of subjects analysed
    147 [27]
    144 [28]
    Units: Nanomoles per 24 hours (nmol/24 hrs)
    geometric mean (full range (min-max))
        Baseline - Geometric Mean
    32.71 (2.7 to 156.2)
    30.88 (4.2 to 891.6)
        Week 12 - Geometric Mean
    25.03 (1.7 to 152.6)
    23.17 (5.3 to 145.8)
    Notes
    [27] - Cortisol Population
    [28] - Cortisol Population
    No statistical analyses for this end point

    Primary: Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion

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    End point title
    		 Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion [29]
    End point description
    Normal range for Cortisol levels vary by age and gender. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [29] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol HFA Fluticasone Propionate HFA
    Number of subjects analysed
    147 [30]
    144 [31]
    Units: ratio
        number (not applicable)
    0.77
    0.75
    Notes
    [30] - Cortisol Population
    [31] - Cortisol Population
    No statistical analyses for this end point

    Primary: Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use

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    End point title
    		 Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use [32]
    End point description
    AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. "Abnormal high cortisol excretion" and "Abnormal low cortisol excretion" are defined as above the upper limit of normal and below the lower limit of normal, respectively. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [32] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol HFA - Spacer Fluticasone Propionate/Salmeterol HFA - No Spacer Fluticasone Propionate HFA - Spacer Fluticasone Propionate HFA - No Spacer
    Number of subjects analysed
    115 [33]
    32 [34]
    113 [35]
    31 [36]
    Units: participants
    number (not applicable)
        Baseline - Abnormal high cortisol excretion
    12
    1
    14
    3
        Baseline - Abnormal low cortisol excretion
    0
    1
    0
    0
        Week 12 - Abnormal high cortisol excretion
    10
    3
    7
    1
        Week 12 - Abnormal low cortisol excretion
    2
    0
    0
    0
    Notes
    [33] - Cortisol Population
    [34] - Cortisol Population
    [35] - Cortisol Population
    [36] - Cortisol Population
    No statistical analyses for this end point

    Primary: Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12

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    End point title
    		 Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12 [37]
    End point description
    AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [37] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol HFA - Spacer Fluticasone Propionate/Salmeterol HFA - No Spacer Fluticasone Propionate HFA - Spacer Fluticasone Propionate HFA - No Spacer
    Number of subjects analysed
    115 [38]
    32 [39]
    113 [40]
    31 [41]
    Units: Nanomoles per 24 hours (nmol/24 hrs)
    geometric mean (full range (min-max))
        Baseline - Geometric Mean
    31.89 (3.6 to 156.2)
    35.84 (2.7 to 143.3)
    30.61 (4.2 to 891.6)
    31.89 (7.9 to 335)
        Week 12 - Geometric Mean
    23.37 (1.7 to 143.3)
    32.05 (4.6 to 152.6)
    23.2 (5.3 to 103.2)
    23.06 (5.4 to 145.8)
    Notes
    [38] - Cortisol Population
    [39] - Cortisol Population
    [40] - Cortisol Population
    [41] - Cortisol Population
    No statistical analyses for this end point

    Primary: Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use

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    End point title
    		 Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use [42]
    End point description
    AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [42] - 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 statitiscal analysis for this endpoint.
    End point values
    		 Fluticasone Propionate/Salmeterol HFA - Spacer Fluticasone Propionate/Salmeterol HFA - No Spacer Fluticasone Propionate HFA - Spacer Fluticasone Propionate HFA - No Spacer
    Number of subjects analysed
    115 [43]
    32 [44]
    113 [45]
    31 [46]
    Units: ratio
        number (not applicable)
    0.73
    0.89
    0.76
    0.72
    Notes
    [43] - Cortisol Population
    [44] - Cortisol Population
    [45] - Cortisol Population
    [46] - Cortisol Population
    No statistical analyses for this end point

    Secondary: Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years

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    End point title
    		 Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years
    End point description
    FEV1 (Forced Expiratory Volume in 1 second) is the volume of air that can be forced out in one second, after taking a deep breath. FEV1 is measured using a spirometer and obtaining "best effort" from 3 to 8 measurements. Week 12 is the measure taken at Week 12. A Subset of the ITT Population included participants who were 6-11 years of age (population not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 137 and 136 at baseline; 126 and 124 at Week 12, and 6 and 7 at premature discontinuation.
    End point type
    Secondary
    End point timeframe
    Baseline and week 12
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    137 [47]
    136 [48]
    Units: Liters per second (L/sec)
    arithmetic mean (standard error)
        Baseline - Mean FEV1
    1.67 ± 0.035
    1.64 ± 0.035
        Week 12 - Mean FEV1
    1.91 ± 0.038
    1.82 ± 0.036
        Week 12 - Mean Change from baseline
    0.24 ± 0.023
    0.18 ± 0.023
        Premature discontinuation - Mean FEV1
    1.81 ± 0.14
    1.7 ± 0.212
        Premature discontin. - Mean Change from baseline
    0.03 ± 0.09
    -0.07 ± 0.12
    Notes
    [47] - Subset of ITT Population
    [48] - Subset of ITT Population
    No statistical analyses for this end point

    Secondary: AM Peak Expiratory Flow

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    End point title
    		 AM Peak Expiratory Flow
    End point description
    The peak expiratory flow (PEF) rate measures how fast a person can exhale air. It is used to compare to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 inches is 147 Liters/minute (L/min), whose height is 66 inches is 454 L/min. Triplicate measurements taken for the best effort recorded. Participants from the ITT Population (not necessarily selected to show efficacy differences) were analyzed. Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 173 and 174 at Weeks 1-12; and 171 and 173 for the last 7 days on treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and 12-Week Treatment Period
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [49]
    177 [50]
    Units: Liters/minute (L/min)
    arithmetic mean (standard error)
        Baseline - Mean AM PEF
    213 ± 4.83
    203 ± 4.37
        Weeks 1-12 - Mean AM PEF
    233 ± 5.07
    220 ± 4.43
        Weeks 1-12 - Mean Change from Baseline
    20.2 ± 2.04
    17.4 ± 1.86
        Last 7 Days on Treatment - Mean AM PEF
    238 ± 5.39
    226 ± 4.73
        Last 7 Days on Treatment-Mean Change from Baseline
    25.3 ± 2.58
    23.3 ± 2.47
    Notes
    [49] - ITT Population
    [50] - ITT Population
    No statistical analyses for this end point

    Secondary: Asthma Symptom Scores

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    End point title
    		 Asthma Symptom Scores
    End point description
    Each morning prior dosing or PEF, self-scored based on past 24 hours: 0=No symptoms, 1=Symptoms for one short period, 2=Symptoms for two or more short periods, 3=Frequent Symptoms which did not affect activities of daily living (ADL), 4=Frequent. Participants from the ITT population (not necessarily selected to show efficacy differences) were analyzed. Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and 12-Week Treatment Period
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [51]
    177 [52]
    Units: Score in scale
    arithmetic mean (standard deviation)
        Baseline - Mean Score
    1.3 ± 0.06
    1.4 ± 0.06
        Weeks 1-12 - Mean Score
    0.9 ± 0.06
    0.8 ± 0.05
        Weeks 1-12 - Mean change from baseline
    -0.4 ± 0.06
    -0.6 ± 0.06
        Last 7 Days on Treatment - Mean Score
    0.8 ± 0.07
    0.8 ± 0.07
        Last 7 Days on Treat. - Mean change from baseline
    -0.5 ± 0.07
    -0.6 ± 0.08
    Notes
    [51] - ITT population
    [52] - ITT population
    No statistical analyses for this end point

    Secondary: Percentage of Symptom Free Days

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    End point title
    		 Percentage of Symptom Free Days
    End point description
    Percentage of number of days without asthma symptoms based on Asthma Symptom Scores. Each morning prior to dosing or PEF, asthma symptoms were self-scored based on the past 24 hours: 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=frequent symptoms that did not affect activities of daily living (ADL), 4=frequent. Participants from the ITT population (not necessarily selected to show efficacy differences) were analyzed. Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and 12-Week Treatment Period
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [53]
    177 [54]
    Units: Percentage of days
    arithmetic mean (standard error)
        Baseline - Mean Percent
    20 ± 2.02
    18.4 ± 2
        Weeks 1-12 - Mean Percent
    46.7 ± 2.77
    48.7 ± 2.8
        Weeks 1-12 - Mean change from baseline
    26.8 ± 2.47
    30.5 ± 2.62
        Last 7 Days on Treatment - Mean Percent
    51.9 ± 3.51
    53.4 ± 3.44
        Last 7 Days on Treat. - Mean change from baseline
    32.1 ± 3.32
    34.9 ± 3.43
    Notes
    [53] - ITT population
    [54] - ITT population
    No statistical analyses for this end point

    Secondary: Albuterol Use

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    End point title
    		 Albuterol Use
    End point description
    Albuterol inhalation aerosol was used as a rescue or prophylactic and recorded daily by subject or caregiver. The number of puffs of albuterol over the previous 24 hour period prior to dosing was recorded. Participants from the ITT population (not necessarily selected to show efficacy differences) were analyzed. Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and 12-Week Treatment Period
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [55]
    177 [56]
    Units: Number of puffs per 24 hours
    arithmetic mean (standard error)
        Baseline - Mean number of puffs
    1.5 ± 0.12
    1.8 ± 0.19
        Weeks 1-12 - Mean number of puffs
    1 ± 0.09
    0.9 ± 0.09
        Weeks 1-12 - Mean change from baseline
    -0.6 ± 0.12
    -1 ± 0.16
        Last 7 Days on Treatment - Mean number of puffs
    0.7 ± 0.11
    0.7 ± 0.11
        Last 7 Days on Treat. - Mean change from baseline
    -0.8 ± 0.15
    -1.2 ± 0.19
    Notes
    [55] - ITT population
    [56] - ITT population
    No statistical analyses for this end point

    Secondary: Percent of Albuterol-free Days

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    End point title
    		 Percent of Albuterol-free Days
    End point description
    Percentage of days when Albuterol use was unnecessary based on daily record and symptom free days. Participants from the ITT population (not necessarily selected to show efficacy differences) were analyzed. Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and 12-Week Treatment Period
    End point values
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Number of subjects analysed
    173 [57]
    177 [58]
    Units: Percentage of days
    arithmetic mean (standard error)
        Baseline - Mean percent rescue free
    43.7 ± 2.85
    42.5 ± 3.04
        Weeks 1-12 - Mean percent rescue free
    67.1 ± 2.46
    70 ± 2.4
        Weeks 1-12 - Mean change from baseline
    23.6 ± 2.79
    28.3 ± 2.93
        Last 7 Days on Treat. - Mean percent rescue free
    75.4 ± 2.96
    75.8 ± 2.98
        Last 7 Days on Treat. - Mean change from baseline
    30.4 ± 3.5
    32.8 ± 3.58
    Notes
    [57] - ITT population
    [58] - ITT population
    No statistical analyses for this end point

    Post-hoc: Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12

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    End point title
    		 Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12
    End point description
    A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nanomoles/24 hours. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.
    End point type
    Post-hoc
    End point timeframe
    Baseline and Week 12
    End point values
    		 Fluticasone Propionate/Salmeterol HFA Fluticasone Propionate HFA
    Number of subjects analysed
    147 [59]
    140 [60]
    Units: Nanamoles per 24 hours (nmol/24 hrs)
    geometric mean (full range (min-max))
        Baseline - Geometric Mean
    32.71 (2.7 to 156.2)
    28.39 (4.2 to 146.9)
        Week 12 - Geometric Mean
    25.03 (1.7 to 152.6)
    22.8 (5.3 to 145.8)
    Notes
    [59] - Cortisol Population
    [60] - Cortisol Population
    No statistical analyses for this end point

    Post-hoc: Geometric Mean Ratio for Baseline:Week12 24-hour Urinary Cortisol Excretion

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    End point title
    		 Geometric Mean Ratio for Baseline:Week12 24-hour Urinary Cortisol Excretion
    End point description
    A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nmol/24 hrs. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).
    End point type
    Post-hoc
    End point timeframe
    Baseline and Week 12
    End point values
    		 Fluticasone Propionate/Salmeterol HFA Fluticasone Propionate HFA
    Number of subjects analysed
    147 [61]
    140 [62]
    Units: ratio
        number (not applicable)
    0.77
    0.8
    Notes
    [61] - Cortisol Population
    [62] - Cortisol Population
    No statistical analyses for this end point

    Post-hoc: Geometric Mean Values of 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population at Baseline and Week 12

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    End point title
    		 Geometric Mean Values of 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population at Baseline and Week 12
    End point description
    AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.
    End point type
    Post-hoc
    End point timeframe
    Baseline and Week 12
    End point values
    		 FP/S HFA or FP HFA - No Spacer FP/S HFA or FP HFA - Spacer
    Number of subjects analysed
    58 [63]
    202 [64]
    Units: Nanomoles per 24 hr (nmoles/24 hr)
    geometric mean (full range (min-max))
        Baseline - Geometric Mean
    31.88 (7.9 to 81.7)
    27.08 (3.6 to 166.3)
        Week 12 - Geometric Mean
    27.85 (5.4 to 152.6)
    22.38 (1.7 to 143.3)
    Notes
    [63] - Cortisol Population
    [64] - Cortisol Population
    No statistical analyses for this end point

    Post-hoc: Geometric mean ratio for Baseline:Week 12 24-hour Urinary Cortisol Excretion by Spacer use Excluding Participants with Abnormal Urinary Cortisol Excretion Values at Baseline from the Cortisol Population

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    End point title
    		 Geometric mean ratio for Baseline:Week 12 24-hour Urinary Cortisol Excretion by Spacer use Excluding Participants with Abnormal Urinary Cortisol Excretion Values at Baseline from the Cortisol Population
    End point description
    AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value,nanomoles per 24 hours (nmol/24 hrs).
    End point type
    Post-hoc
    End point timeframe
    Baseline and Week 12
    End point values
    		 FP/S HFA or FP HFA - No Spacer FP/S HFA or FP HFA - Spacer
    Number of subjects analysed
    58 [65]
    202 [66]
    Units: ratio
        number (not applicable)
    0.87
    0.83
    Notes
    [65] - Cortisol Population
    [66] - Cortisol Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)
    Reporting group description
    		 Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (μg) HFA (2 inhalations of 50/25 μg), twice daily for 12 weeks.

    Reporting group title
    Fluticasone Propionate Hydrofluoroalkane (HFA)
    Reporting group description
    		 Participants who were randomly assigned to Fluticasone Propionate 100 μg HFA (2 inhalations of 50 μg), twice daily for 12 weeks.

    Serious adverse events
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 177 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head Injury due to fall
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 177 (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: 2%
    Non-serious adverse events
    		 Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) Fluticasone Propionate Hydrofluoroalkane (HFA)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 173 (35.26%)
    68 / 177 (38.42%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 173 (15.03%)
    25 / 177 (14.12%)
         occurrences all number
    54
    34
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    8 / 173 (4.62%)
    16 / 177 (9.04%)
         occurrences all number
    9
    17
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 173 (5.20%)
    7 / 177 (3.95%)
         occurrences all number
    14
    9
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    16 / 173 (9.25%)
    21 / 177 (11.86%)
         occurrences all number
    21
    42
    Pharyngitis
         subjects affected / exposed
    4 / 173 (2.31%)
    12 / 177 (6.78%)
         occurrences all number
    5
    14
    Rhinitis
         subjects affected / exposed
    8 / 173 (4.62%)
    6 / 177 (3.39%)
         occurrences all number
    9
    10
    Upper Respiratory Tract Infection
         subjects affected / exposed
    11 / 173 (6.36%)
    13 / 177 (7.34%)
         occurrences all number
    11
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2006
    Amendment 01: The protocol was amended to change the study design from a double-blind to a double-blind, double-dummy. The protocol was revised to clarify the following: the fluticasone propionate/salmeterol and fluticasone strengths are in ex-valve strength, to further explain the rationale of the study is to provide information on the relative safety of adding a beta2-agonist to ICS treatment, the data will be stratified by age as well as spacer use, laboratory results for subjects who rescreen taken do not need to be taken again prior to randomization, PI oversight for safety measures obtained during the study, how Reversibility is to be obtained, that one spacer should be used for both study drug inhalers and rescue medication, the Time & Events (T&E) Visit 1 is 14+or =2 days prior to Visit 2, also in the T&E table that PGx samples can be obtained at the Premature Discontinuation Visit, and finally that a throat culture should be taken in subjects with evidence of candidiasis. The following items were added to the protocol: a statement to Exclusion Criteria # 12 to reflect that QTc intervals > 449 will disqualify a subject from participating in the study, 24 hour Urine Collection to be done within 7 days prior to Visit 2, Historical Reversibility obtained as FEV1 or PEF is acceptable. The following updates were made for administrative purposes: Added UK GSK address, changed Medical Monitor Name and contact information, updated Investigator Protocol Agreement Page.

    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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