<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03248128</url>
  </required_header>
  <id_info>
    <org_study_id>107116</org_study_id>
    <secondary_id>2016-004086-87</secondary_id>
    <nct_id>NCT03248128</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma</brief_title>
  <official_title>A Randomised, Double-blind, Parallel Group, Multicentre, Stratified, Study Evaluating the Efficacy and Safety of Once Daily Fluticasone Furoate/Vilanterol Inhalation Powder Compared to Once Daily Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Participants Aged 5 to 17 Years Old (Inclusive) Currently Uncontrolled on Inhaled Corticosteroids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of asthma treatment is to achieve and maintain asthma control and to reduce the&#xD;
      future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most&#xD;
      effective anti- inflammatory treatment for all severities of persistent asthma. For children&#xD;
      &gt;=5 years of age and adolescents whose asthma is uncontrolled, low-dose ICS plus adjunctive&#xD;
      therapy with long-acting beta agonist (LABA) is considered as effective. Thus, this study is&#xD;
      designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component)&#xD;
      compared to FF alone for the treatment of asthma, in subjects aged 5 to 17 years old&#xD;
      currently uncontrolled on ICS. The study will be conducted over a total duration of&#xD;
      approximately 29 weeks: 4 week run-in period, 24-week double-blind treatment period and&#xD;
      1-week follow-up period. Subjects will be randomized to receive FDC of FF/VI or FF&#xD;
      administered via ELLIPTA® dry powder inhaler (DPI). The dose of both FF/VI and FF alone will&#xD;
      be selected based on the age of subjects. Subjects will receive a short acting beta 2 agonist&#xD;
      (SABA) (albuterol /salbutamol) as a rescue medication throughout the study. A total of 870&#xD;
      subjects will be randomized in the study. Of this, 652 subjects will be aged 5 to 11 years&#xD;
      (cohort A), and 218 will be aged 12 to 17 years inclusive (cohort B). ELLIPTA is a registered&#xD;
      trademark of GlaxoSmithKline (GSK) group of companies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Actual">March 21, 2022</completion_date>
  <primary_completion_date type="Actual">March 21, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will be randomized to receive FDC of FF/VI inhalation powder compared to FF inhalation powder, once daily in cohort A and cohort B.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This will be a double blind study. Subjects and investigator will be masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Weighted Mean of Forced Expiratory Volume in 1 Second (FEV1) (0-4 Hours) at Week 12 in 5-17 Year Old Population</measure>
    <time_frame>Week 12</time_frame>
    <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Mean Pre-dose Morning Peak Expiratory Flow (AM PEF) in 5-11 Year Old Population</measure>
    <time_frame>Baseline and Week 1-12</time_frame>
    <description>PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the electronic patient diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Pre-dose AM PEF Period in 5-17 Year Old Population</measure>
    <time_frame>Baseline and Week 1-12</time_frame>
    <description>PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the daily diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Weighted Mean of FEV1 (0-4 Hours) at Week 12 in 5-11 Year Old Population</measure>
    <time_frame>Week 12</time_frame>
    <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population</measure>
    <time_frame>Baseline and Week 1-12</time_frame>
    <description>The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population</measure>
    <time_frame>Baseline and Week 1-12</time_frame>
    <description>The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-17 Year Old Population</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non missing value on Visit 2 (Day -5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24 in 5-17 Year Old Population</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population</measure>
    <time_frame>Baseline and Week 1-12</time_frame>
    <description>The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population</measure>
    <time_frame>Baseline and Week 1-12</time_frame>
    <description>The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-11 Year Old Population</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 2 (Day -5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline ACQ-5 Score at Week 24 in 5-11 Year Old Population</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in 5-17 Year Old Population</measure>
    <time_frame>Up to week 25</time_frame>
    <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Electrocardiogram (ECG) Findings in 5-17 Year Old Population</measure>
    <time_frame>Week 24</time_frame>
    <description>A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QT interval corrected (QTc).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Glucose in 5-17 Year Old Population</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-17 Year Old Population</measure>
    <time_frame>Up to week 24</time_frame>
    <description>Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With AEs and SAEs in 5-11 Year Old Population</measure>
    <time_frame>Up to week 25</time_frame>
    <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/Standard of care (SOC) to prevent one of the other outcomes mentioned before.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal ECG Findings in 5-11 Year Old Population</measure>
    <time_frame>Week 24</time_frame>
    <description>A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QTc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Glucose in 5-11 Year Old Population</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-11 Year Old Population</measure>
    <time_frame>Up to week 24</time_frame>
    <description>Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">906</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Subjects receiving FF/VI in cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 50/25 mcg administered once daily in the morning via ELLIPTA DPI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects receiving FF in cohort A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized in 1:1 ratio to receive FF with a dose of 50 mcg administered once daily in the morning via ELLIPTA DPI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects receiving FF/VI in cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 100/25 mcg administered once daily in the morning via ELLIPTA DPI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects receiving FF in cohort B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized in 1:1 ratio to receive FF with a dose of 100 mcg administered once daily in the morning via ELLIPTA DPI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FF/VI via ELLIPTA DPI</intervention_name>
    <description>ELLIPTA DPI inhaler will contain two individual blister strips; the first strip will contain FF(50 or 100 mcg) and second strip will contain VI (25 mcg).</description>
    <arm_group_label>Subjects receiving FF/VI in cohort A</arm_group_label>
    <arm_group_label>Subjects receiving FF/VI in cohort B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FF via ELLIPTA DPI</intervention_name>
    <description>ELLIPTA DPI inhaler will contain a single blister strip of FF (50 or 100 mcg).</description>
    <arm_group_label>Subjects receiving FF in cohort A</arm_group_label>
    <arm_group_label>Subjects receiving FF in cohort B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For all subjects: Between 5 and 17 years of age inclusive, at the time of signing the&#xD;
             informed consent.&#xD;
&#xD;
          -  A history of symptoms consistent with a diagnosis of asthma for at least 6 months.&#xD;
&#xD;
          -  Pre-bronchodilator FEV1 &gt;50 percent to &lt;=90 percent predicted normal. A minimum of 2&#xD;
             efforts that are considered acceptable (not necessarily repeatable) are required to be&#xD;
             eligible.&#xD;
&#xD;
          -  Lung function reversibility defined as an increase of &gt;=12 percent in FEV1 within 10&#xD;
             to 40 minutes following 2 to 4 inhalations of salbutamol inhalation aerosol (or 1&#xD;
             nebulized treatment with albuterol/salbutamol solution). Use of a spacer is permitted.&#xD;
&#xD;
          -  Uncontrolled asthma, with a childhood asthma control test (cACT)/ACT score &lt;=19.&#xD;
&#xD;
          -  Receiving stable asthma therapy (SABA inhaler plus ICS [total daily dose &lt;=FP 250&#xD;
             micrograms (mcg) or equivalent]) for at least 4 weeks prior to Visit 1 (i.e.&#xD;
             screening).&#xD;
&#xD;
          -  Able to replace their current SABA treatment with salbutamol aerosol inhaler at Visit&#xD;
             1 for use as needed for the duration of the study. Salbutamol metered dose inhaler&#xD;
             (MDI) will be administered with or without a spacer, to be used as determined by the&#xD;
             investigator. The use or non-use of the spacer should be consistent for an individual&#xD;
             subject throughout the study.&#xD;
&#xD;
          -  Male or female subjects will be included. Females of reproductive potential must agree&#xD;
             to follow 1 of the options listed (which include abstinence) in the Modified List of&#xD;
             Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential&#xD;
             (FRP) from 30 days prior to the first dose of study medication and until at least five&#xD;
             terminal half-lives or until any continuing pharmacologic effect has ended, whichever&#xD;
             is longer after the last dose of study medication and completion of the follow-up&#xD;
             call. The investigator is responsible for ensuring that subjects understand how to&#xD;
             properly use these methods of contraception.&#xD;
&#xD;
          -  Written informed consent from at least 1 parent/care giver (legal guardian) and&#xD;
             accompanying informed assent from the subject (where the subject is able to provide&#xD;
             assent) prior to admission to the study. If applicable, subject must be able and&#xD;
             willing to give assent to take part in the study according to the local requirement.&#xD;
             The study investigator is accountable for determining a child's capacity to assent to&#xD;
             participation in a research study, taking into consideration any standards set by the&#xD;
             responsible independent ethics committee (IEC); subject and their legal guardian(s)&#xD;
             understand that the study requires them to be treated on an outpatient basis; subject&#xD;
             and their legal guardian(s) understand that they must comply with study medication and&#xD;
             study assessments including recording of PEF and rescue SABA use, attending scheduled&#xD;
             study visits, and being accessible by a telephone call.&#xD;
&#xD;
          -  For subjects eligible for randomization; asthma control: uncontrolled asthma, with a&#xD;
             cACT/ACT score &lt;=19.&#xD;
&#xD;
          -  A technically acceptable pre-bronchodilator FEV1 &gt;50 percent to &lt;=90 percent predicted&#xD;
             normal at Visit 2. A minimum of 2 efforts that are considered acceptable and&#xD;
             repeatable following the over read are required to be eligible.&#xD;
&#xD;
          -  Symptoms and rescue use: demonstrated and reported in a daily diary symptoms of asthma&#xD;
             (a score of &gt;=1 on the day-time or night-time asthma symptom scores) and/or daily&#xD;
             albuterol/salbutamol on at least 3 of the last 7 consecutive days of the run-in period&#xD;
             (not including the date of randomization).&#xD;
&#xD;
          -  Compliance with run-in medication: compliance is defined as use of run-in medication&#xD;
             on at least 4 of the last 7 consecutive days of the run-in period (not including the&#xD;
             date of randomization) recorded in the electronic subject diary.&#xD;
&#xD;
          -  Compliance with completion of the daily diary reporting: defined as completion of all&#xD;
             questions on 4 out of the last 7 days during the run-in period (not including the date&#xD;
             of randomization).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For all subjects: History of life threatening asthma defined as an asthma episode that&#xD;
             required intubation and/or was associated with hypercapnea, respiratory arrest or&#xD;
             hypoxic seizures.&#xD;
&#xD;
          -  Any asthma exacerbation requiring the use of oral steroids within 6 weeks of Visit 1,&#xD;
             systemic or depot corticosteroids within 12 weeks of Visit 1, or ER attendance within&#xD;
             3 months of Visit 1 or hospitalization within 6 months of Visit 1.&#xD;
&#xD;
          -  A culture documented or suspected bacterial or viral infection of the upper or lower&#xD;
             respiratory tract, sinus or middle ear that has not resolved within 4 weeks of Visit 1&#xD;
             and which led to a change in asthma management or, in the opinion of the investigator,&#xD;
             is expected to affect the subject's asthma status or the subject's ability to&#xD;
             participate in the study.&#xD;
&#xD;
          -  Clinical visual evidence of oropharyngeal candidiasis.&#xD;
&#xD;
          -  Fasting blood glucose at screening &gt;100 milligrams/deciliter (mg/dL) (5.6 moles per&#xD;
             liter [mol/L]).&#xD;
&#xD;
          -  Obesity (Body Mass Index [BMI] above the 97th centile based on the centers for disease&#xD;
             control and prevention [CDC] charts).&#xD;
&#xD;
          -  Any significant abnormality or medical condition identified at the screening medical&#xD;
             assessment (including serious psychological disorder) that in the investigator's&#xD;
             opinion, preclude entry into the study due to risk to the subject or that may&#xD;
             interfere with the conduct and/or outcome of the study.&#xD;
&#xD;
          -  QTc &gt;450 milliseconds (msec) or QTc &gt;480 msec in subjects with bundle branch block or&#xD;
             any other clinically significant abnormality in the screening 12-lead ECG.&#xD;
&#xD;
          -  Use of any prohibited medications.&#xD;
&#xD;
          -  Present use of any tobacco products.&#xD;
&#xD;
          -  Drug allergies: any adverse reaction including immediate or delayed hypersensitivity&#xD;
             to any beta 2-agonists, sympathomimetic drug or any intranasal, inhaled, or systemic&#xD;
             corticosteroid therapy. Known or suspected sensitivity to the constituents of the&#xD;
             ELLIPTA Inhaler (i.e. lactose or magnesium stearate).&#xD;
&#xD;
          -  Milk Protein Allergy: history of severe milk protein allergy.&#xD;
&#xD;
          -  Participated in a clinical trial and has received an investigational product within&#xD;
             the following time period prior to the first dosing day in the current study: 30 days,&#xD;
             five half-lives or twice the duration of the biological effect of the study treatment&#xD;
             (whichever is longer).&#xD;
&#xD;
          -  Exposure to more than 4 investigational medicinal products within 12 months prior to&#xD;
             the first dosing day.&#xD;
&#xD;
          -  An affiliation with the investigator site: the parents/guardians or child is an&#xD;
             immediate family member of the participating investigator, sub-investigator, study&#xD;
             coordinator, or employee of the participating investigator.&#xD;
&#xD;
          -  The parent or guardian has a history of psychiatric disease, intellectual deficiency,&#xD;
             substance abuse or other condition (example, inability to read, comprehend or write)&#xD;
             which may affect: validity of consent to participate in the study; adequate&#xD;
             supervision of the subject during the study; compliance of subject with study&#xD;
             medication and study procedures (example, completion of daily diary, attending&#xD;
             scheduled clinic visits); subject safety and well-being.&#xD;
&#xD;
          -  Children in care: children who are wards of the government or state are not eligible&#xD;
             for participation in this study.&#xD;
&#xD;
          -  For subjects eligible for randomization; Changes in asthma medication that occur after&#xD;
             screening.&#xD;
&#xD;
          -  Occurrence of a culture-documented or suspected bacterial or viral infection of the&#xD;
             upper or lower respiratory tract, sinus or middle ear during the run-in period that&#xD;
             led to a change in asthma management or, in the opinion of the investigator, is&#xD;
             expected to affect the subject's asthma status or the subject's ability to participate&#xD;
             in the study.&#xD;
&#xD;
          -  Evidence of an exacerbation, defined as a: deterioration of asthma requiring the use&#xD;
             of oral corticosteroids for at least 3 days, or a depot corticosteroid injection, or&#xD;
             an in-patient hospitalization due to asthma that required systemic corticosteroids&#xD;
             between screening and randomization.&#xD;
&#xD;
          -  Clinical visual evidence of oropharyngeal candidiasis at the randomization Visit.&#xD;
&#xD;
          -  Unable to use the ELLIPTA inhaler correctly.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hoover</city>
        <state>Alabama</state>
        <zip>35244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oak Park</city>
        <state>Illinois</state>
        <zip>60301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>White Marsh</city>
        <state>Maryland</state>
        <zip>21162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Piscataway</city>
        <state>New Jersey</state>
        <zip>08854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Verona</city>
        <state>New Jersey</state>
        <zip>07044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New Hartford</city>
        <state>New York</state>
        <zip>13413</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Grove City</city>
        <state>Ohio</state>
        <zip>43123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wexford</city>
        <state>Pennsylvania</state>
        <zip>15090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118-2040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29485</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231-4307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lewisville</city>
        <state>Texas</state>
        <zip>75067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berazategui</city>
        <state>Buenos Aires</state>
        <zip>1837</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1028AAP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1425BEN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1122AAK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Florida</city>
        <state>Buenos Aires</state>
        <zip>1602</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <zip>1900</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lanús</city>
        <state>Buenos Aires</state>
        <zip>B1824KAJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lobos</city>
        <state>Buenos Aires</state>
        <zip>7240</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mar del Plata</city>
        <state>Buenos Aires</state>
        <zip>7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nueve de Julio</city>
        <state>Buenos Aires</state>
        <zip>B6500BWQ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1121ABE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1425FVH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <zip>C1121ABE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <zip>C1426ABP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mendoza</city>
        <zip>M5500CCG</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rosario</city>
        <zip>S2000BRH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santa Fe</city>
        <zip>3000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1510</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1784</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stara Zagora</city>
        <zip>5400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6T 0G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8X2G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Québec</city>
        <zip>G1V 4W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Panzhihua</city>
        <state>Sichuan</state>
        <zip>617023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taiyuan</city>
        <zip>030013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Wuerttemberg</state>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Wuerttemberg</state>
        <zip>68161</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rosenheim</city>
        <state>Bayern</state>
        <zip>83026</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Geesthacht</city>
        <state>Schleswig-Holstein</state>
        <zip>21502</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Budapest</city>
        <zip>1089</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Szeged</city>
        <zip>H-6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Parma</city>
        <state>Emilia-Romagna</state>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bergamo</city>
        <state>Lombardia</state>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20154</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ancona</city>
        <state>Marche</state>
        <zip>60123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>9000</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Perugia</city>
        <state>Umbria</state>
        <zip>06156</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>260-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukui</city>
        <zip>918-8205</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1394</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>813-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hiroshima</city>
        <zip>721-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>040-8585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>040-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hyogo</city>
        <zip>653-0836</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>223-0059</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>583-8588</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>154-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>157-0066</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>158-0097</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>171-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>176-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vilnius</city>
        <zip>9108</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44670</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zapopan</city>
        <state>Jalisco</state>
        <zip>45070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64710</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Villahermosa</city>
        <state>Tabasco</state>
        <zip>86035</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-430</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15879</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Czestochowa</city>
        <zip>42-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krakow</city>
        <zip>31-011</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lodz</city>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lodz</city>
        <zip>90-329</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ostrow Wielkopolski</city>
        <zip>63-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ostrowiec Swietokrzyski</city>
        <zip>27-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-693</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Skierniewice</city>
        <zip>96-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Strzelce Opolskie</city>
        <zip>47-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tarnow</city>
        <zip>33-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>01-192</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-088</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zawadzkie</city>
        <zip>47-120</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brasov</city>
        <zip>500091</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brasov</city>
        <zip>500283</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>020395</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>030961</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>051543</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Targu Mures</city>
        <zip>540136</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krasnodar</city>
        <zip>350012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>1154461</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>119333</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>119435</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>127473</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>129110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Omsk</city>
        <zip>644050</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Penza</city>
        <zip>440067</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Perm</city>
        <zip>614066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>192148</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>192212</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>196657</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>193312</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>196191</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Samara</city>
        <zip>443031</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saransk</city>
        <zip>430000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saratov</city>
        <zip>410012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St Petersburg</city>
        <zip>196240</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St'Petersburg</city>
        <zip>191144</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194100</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194223</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tomsk</city>
        <zip>634 050</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ufa</city>
        <zip>450008</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Volgograd</city>
        <zip>400131</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Voronezh</city>
        <zip>394036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boksburg</city>
        <state>Gauteng</state>
        <zip>1459</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1818</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0083</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0184</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Middelburg</city>
        <state>Mpumalanga</state>
        <zip>1055</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Panorama</city>
        <state>Western Province</state>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bellville</city>
        <zip>7530</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bloemfontein</city>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7700</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Durban</city>
        <zip>4001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pretoria</city>
        <zip>0181</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Somerset West</city>
        <zip>7130</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Soweto</city>
        <zip>1818</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Umkomaas</city>
        <zip>4170</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vosloorus Ext 2</city>
        <zip>1475</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>China</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Lithuania</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <results_first_submitted>September 12, 2022</results_first_submitted>
  <results_first_submitted_qc>September 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2022</results_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fluticasone furoate</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Vilanterol</keyword>
  <keyword>Asthma</keyword>
  <keyword>Safety</keyword>
  <keyword>GW642444</keyword>
  <keyword>GW685698</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03248128/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03248128/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>2402 participants screened, 906 participants were randomized, of which 4 participants did not receive study treatment. 902 participants received at least 1 dose of study medication creating the Intent to treat (ITT) Population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Participants Who Received Fluticasone Furoate/Vilanterol (FF/ VI) Fixed Dose Combination (FDC)</title>
          <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 micrograms (mcg) and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA dry powder inhaler (DPI). Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
        </group>
        <group group_id="P2">
          <title>Participants Who Received FF</title>
          <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="455"/>
                <participants group_id="P2" count="451"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ITT Population</title>
              <participants_list>
                <participants group_id="P1" count="454"/>
                <participants group_id="P2" count="448"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="433"/>
                <participants group_id="P2" count="431"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site Closed</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized, but did not receive treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline Characteristic data are reported for 902 participants who received at least 1 dose of study medication creating the ITT Population.</population>
      <group_list>
        <group group_id="B1">
          <title>Participants Who Received FF/ VI FDC</title>
          <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
        </group>
        <group group_id="B2">
          <title>Participants Who Received FF</title>
          <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="454"/>
            <count group_id="B2" value="448"/>
            <count group_id="B3" value="902"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>YEARS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.9" spread="3.02"/>
                    <measurement group_id="B2" value="10.0" spread="2.97"/>
                    <measurement group_id="B3" value="10.0" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="191"/>
                    <measurement group_id="B3" value="356"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="289"/>
                    <measurement group_id="B2" value="257"/>
                    <measurement group_id="B3" value="546"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African American/African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="335"/>
                    <measurement group_id="B2" value="320"/>
                    <measurement group_id="B3" value="655"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Weighted Mean of Forced Expiratory Volume in 1 Second (FEV1) (0-4 Hours) at Week 12 in 5-17 Year Old Population</title>
        <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT population (5-17 years old) included all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified time point have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Weighted Mean of Forced Expiratory Volume in 1 Second (FEV1) (0-4 Hours) at Week 12 in 5-17 Year Old Population</title>
          <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.</description>
          <population>ITT population (5-17 years old) included all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified time point have been analyzed.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="397"/>
                <count group_id="O2" value="399"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.082" spread="0.7598"/>
                    <measurement group_id="O2" value="1.994" spread="0.6998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>0.083</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.037</ci_lower_limit>
            <ci_upper_limit>0.129</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Mean Pre-dose Morning Peak Expiratory Flow (AM PEF) in 5-11 Year Old Population</title>
        <description>PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the electronic patient diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.</description>
        <time_frame>Baseline and Week 1-12</time_frame>
        <population>ITT population (5-11 years old) was a subset of the ITT (5-17 years old) population for participants 11 years old and younger at screening (Visit 1). Only those participants with data available at specified time points have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Pre-dose Morning Peak Expiratory Flow (AM PEF) in 5-11 Year Old Population</title>
          <description>PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the electronic patient diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.</description>
          <population>ITT population (5-11 years old) was a subset of the ITT (5-17 years old) population for participants 11 years old and younger at screening (Visit 1). Only those participants with data available at specified time points have been analyzed.</population>
          <units>Liters per minute (L/min)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="336"/>
                <count group_id="O2" value="335"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="37.63"/>
                    <measurement group_id="O2" value="8.9" spread="35.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.228</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis was performed using analysis of covariance (ANCOVA) with covariates of baseline, region, sex, age and treatment.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>3.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>8.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Pre-dose AM PEF Period in 5-17 Year Old Population</title>
        <description>PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the daily diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.</description>
        <time_frame>Baseline and Week 1-12</time_frame>
        <population>ITT population (5-17 years old). Only those participants with data available at specified time points has been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Pre-dose AM PEF Period in 5-17 Year Old Population</title>
          <description>PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the daily diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.</description>
          <population>ITT population (5-17 years old). Only those participants with data available at specified time points has been analyzed.</population>
          <units>L/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="453"/>
                <count group_id="O2" value="447"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="39.94"/>
                    <measurement group_id="O2" value="9.3" spread="38.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>6.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.4</ci_lower_limit>
            <ci_upper_limit>10.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Weighted Mean of FEV1 (0-4 Hours) at Week 12 in 5-11 Year Old Population</title>
        <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT population (5-11 years old). Only those participants with data available at specified time point have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Weighted Mean of FEV1 (0-4 Hours) at Week 12 in 5-11 Year Old Population</title>
          <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.</description>
          <population>ITT population (5-11 years old). Only those participants with data available at specified time point have been analyzed.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="289"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.762" spread="0.4977"/>
                    <measurement group_id="O2" value="1.711" spread="0.4817"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>0.073</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.028</ci_lower_limit>
            <ci_upper_limit>0.118</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population</title>
        <description>The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
        <time_frame>Baseline and Week 1-12</time_frame>
        <population>ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population</title>
          <description>The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
          <population>ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="453"/>
                <count group_id="O2" value="447"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" spread="33.78"/>
                    <measurement group_id="O2" value="25.8" spread="36.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.870</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>3.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population</title>
        <description>The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
        <time_frame>Baseline and Week 1-12</time_frame>
        <population>ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population</title>
          <description>The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
          <population>ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="453"/>
                <count group_id="O2" value="447"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7" spread="32.77"/>
                    <measurement group_id="O2" value="24.6" spread="34.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.988</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.2</ci_lower_limit>
            <ci_upper_limit>4.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-17 Year Old Population</title>
        <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non missing value on Visit 2 (Day -5).</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>ITT population (5-17 years old). Only those participants with data available at the specified time point has been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-17 Year Old Population</title>
          <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non missing value on Visit 2 (Day -5).</description>
          <population>ITT population (5-17 years old). Only those participants with data available at the specified time point has been analyzed.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="417"/>
                <count group_id="O2" value="413"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.312" spread="0.3865"/>
                    <measurement group_id="O2" value="0.275" spread="0.3512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.124</p_value>
            <method>Repeated measures analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>0.035</param_value>
            <ci_percent>.95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.010</ci_lower_limit>
            <ci_upper_limit>0.080</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24 in 5-17 Year Old Population</title>
        <description>Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24 in 5-17 Year Old Population</title>
          <description>Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).</description>
          <population>ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="385"/>
                <count group_id="O2" value="378"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.21" spread="0.935"/>
                    <measurement group_id="O2" value="-1.09" spread="0.976"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.910</p_value>
            <method>Repeated measures analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population</title>
        <description>The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
        <time_frame>Baseline and Week 1-12</time_frame>
        <population>ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population</title>
          <description>The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
          <population>ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="336"/>
                <count group_id="O2" value="335"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3" spread="34.4"/>
                    <measurement group_id="O2" value="25.6" spread="37.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.614</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis performed using ANCOVA with covariates of baseline, region, sex, age and treatment.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.6</ci_lower_limit>
            <ci_upper_limit>6.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population</title>
        <description>The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
        <time_frame>Baseline and Week 1-12</time_frame>
        <population>ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population</title>
          <description>The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.</description>
          <population>ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="336"/>
                <count group_id="O2" value="335"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" spread="33.16"/>
                    <measurement group_id="O2" value="25.8" spread="34.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.594</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.</method_desc>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.6</ci_lower_limit>
            <ci_upper_limit>6.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-11 Year Old Population</title>
        <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 2 (Day -5).</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/ VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-11 Year Old Population</title>
          <description>Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 2 (Day -5).</description>
          <population>ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="307"/>
                <count group_id="O2" value="304"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.263" spread="0.3029"/>
                    <measurement group_id="O2" value="0.245" spread="0.3192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.226</p_value>
            <method>Repeated measures analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>0.028</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.017</ci_lower_limit>
            <ci_upper_limit>0.073</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline ACQ-5 Score at Week 24 in 5-11 Year Old Population</title>
        <description>Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/ VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline ACQ-5 Score at Week 24 in 5-11 Year Old Population</title>
          <description>Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).</description>
          <population>ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="291"/>
                <count group_id="O2" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.25" spread="0.944"/>
                    <measurement group_id="O2" value="-1.13" spread="0.975"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.663</p_value>
            <method>Repeated measures analysis</method>
            <param_type>Least Square Mean Difference</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.13</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in 5-17 Year Old Population</title>
        <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.</description>
        <time_frame>Up to week 25</time_frame>
        <population>ITT (5-17 years old) population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in 5-17 Year Old Population</title>
          <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.</description>
          <population>ITT (5-17 years old) population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="454"/>
                <count group_id="O2" value="448"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="183"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings in 5-17 Year Old Population</title>
        <description>A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QT interval corrected (QTc).</description>
        <time_frame>Week 24</time_frame>
        <population>ITT population (5-17 years old). Only those participants with data available at the specified time point have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings in 5-17 Year Old Population</title>
          <description>A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QT interval corrected (QTc).</description>
          <population>ITT population (5-17 years old). Only those participants with data available at the specified time point have been analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="402"/>
                <count group_id="O2" value="398"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Glucose in 5-17 Year Old Population</title>
        <description>Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Glucose in 5-17 Year Old Population</title>
          <description>Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).</description>
          <population>ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="370"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.587"/>
                    <measurement group_id="O2" value="-0.15" spread="0.626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-17 Year Old Population</title>
        <description>Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.</description>
        <time_frame>Up to week 24</time_frame>
        <population>ITT population (5-17 years old)</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC</title>
            <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF</title>
            <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-17 Year Old Population</title>
          <description>Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.</description>
          <population>ITT population (5-17 years old)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="454"/>
                <count group_id="O2" value="448"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With AEs and SAEs in 5-11 Year Old Population</title>
        <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/Standard of care (SOC) to prevent one of the other outcomes mentioned before.</description>
        <time_frame>Up to week 25</time_frame>
        <population>Data only for the ITT (5-11 years old) population have been presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/ VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AEs and SAEs in 5-11 Year Old Population</title>
          <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/Standard of care (SOC) to prevent one of the other outcomes mentioned before.</description>
          <population>Data only for the ITT (5-11 years old) population have been presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="337"/>
                <count group_id="O2" value="336"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133"/>
                    <measurement group_id="O2" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal ECG Findings in 5-11 Year Old Population</title>
        <description>A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QTc.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT population (5-11 years old). Only those participants with data available at the specified time point have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal ECG Findings in 5-11 Year Old Population</title>
          <description>A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QTc.</description>
          <population>ITT population (5-11 years old). Only those participants with data available at the specified time point have been analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="303"/>
                <count group_id="O2" value="298"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Glucose in 5-11 Year Old Population</title>
        <description>Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>ITT population (5-11 years old). Only those participants with data available at specified time point have been analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/ VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Glucose in 5-11 Year Old Population</title>
          <description>Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).</description>
          <population>ITT population (5-11 years old). Only those participants with data available at specified time point have been analyzed.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.563"/>
                    <measurement group_id="O2" value="-0.17" spread="0.638"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-11 Year Old Population</title>
        <description>Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.</description>
        <time_frame>Up to week 24</time_frame>
        <population>Data only for the ITT (5-11 years old) population have been presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Received FF/ VI FDC (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received FDC of 50 mcg/ 25 mcg dose of FF/ VI once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
          <group group_id="O2">
            <title>Participants Who Received FF (5-11 Year Old Population)</title>
            <description>Participants aged 5 to 11 years received 50 mcg dose of FF once daily in the morning via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-11 Year Old Population</title>
          <description>Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.</description>
          <population>Data only for the ITT (5-11 years old) population have been presented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="337"/>
                <count group_id="O2" value="336"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Participants Who Received FF/ VI FDC</title>
          <description>5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
        </group>
        <group group_id="E2">
          <title>Participants Who Received FF</title>
          <description>5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="454"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="448"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="454"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="448"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="454"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="448"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="454"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="448"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="454"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="448"/>
              </event>
              <event>
                <sub_title>Helicobacter gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="454"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="448"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="454"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="448"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="454"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="448"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA version 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="107" subjects_at_risk="454"/>
                <counts group_id="E2" subjects_affected="71" subjects_at_risk="448"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="60" subjects_affected="47" subjects_at_risk="454"/>
                <counts group_id="E2" events="42" subjects_affected="34" subjects_at_risk="448"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="454"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="448"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="42" subjects_affected="32" subjects_at_risk="454"/>
                <counts group_id="E2" events="27" subjects_affected="25" subjects_at_risk="448"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="23" subjects_affected="14" subjects_at_risk="454"/>
                <counts group_id="E2" events="13" subjects_affected="9" subjects_at_risk="448"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="22" subjects_affected="19" subjects_at_risk="454"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="448"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03248128
org study id: 107116
secondary id: 2016-004086-87
nct id: NCT03248128
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of asthma treatment is to achieve and maintain asthma control and to reduce the
      future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most
      effective anti- inflammatory treatment for all severities of persistent asthma. For children
      >=5 years of age and adolescents whose asthma is uncontrolled, low-dose ICS plus adjunctive
      therapy with long-acting beta agonist (LABA) is considered as effective. Thus, this study is
      designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component)
      compared to FF alone for the treatment of asthma, in subjects aged 5 to 17 years old
      currently uncontrolled on ICS. The study will be conducted over a total duration of
      approximately 29 weeks: 4 week run-in period, 24-week double-blind treatment period and
      1-week follow-up period. Subjects will be randomized to receive FDC of FF/VI or FF
      administered via ELLIPTA® dry powder inhaler (DPI). The dose of both FF/VI and FF alone will
      be selected based on the age of subjects. Subjects will receive a short acting beta 2 agonist
      (SABA) (albuterol /salbutamol) as a rescue medication throughout the study. A total of 870
      subjects will be randomized in the study. Of this, 652 subjects will be aged 5 to 11 years
      (cohort A), and 218 will be aged 12 to 17 years inclusive (cohort B). ELLIPTA is a registered
      trademark of GlaxoSmithKline (GSK) group of companies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to receive FDC of FF/VI inhalation powder compared to FF inhalation powder, once daily in cohort A and cohort B.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: This will be a double blind study. Subjects and investigator will be masked.
measure: Absolute Weighted Mean of Forced Expiratory Volume in 1 Second (FEV1) (0-4 Hours) at Week 12 in 5-17 Year Old Population
time frame: Week 12
description: Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.
measure: Change From Baseline in Mean Pre-dose Morning Peak Expiratory Flow (AM PEF) in 5-11 Year Old Population
time frame: Baseline and Week 1-12
description: PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the electronic patient diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.
measure: Change From Baseline in Mean Pre-dose AM PEF Period in 5-17 Year Old Population
time frame: Baseline and Week 1-12
description: PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the daily diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.
measure: Absolute Weighted Mean of FEV1 (0-4 Hours) at Week 12 in 5-11 Year Old Population
time frame: Week 12
description: Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.
measure: Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population
time frame: Baseline and Week 1-12
description: The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.
measure: Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population
time frame: Baseline and Week 1-12
description: The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.
measure: Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-17 Year Old Population
time frame: Baseline and Week 12
description: Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non missing value on Visit 2 (Day -5).
measure: Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24 in 5-17 Year Old Population
time frame: Baseline and Week 24
description: Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).
measure: Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population
time frame: Baseline and Week 1-12
description: The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.
measure: Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population
time frame: Baseline and Week 1-12
description: The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.
measure: Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-11 Year Old Population
time frame: Baseline and Week 12
description: Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 2 (Day -5).
measure: Change From Baseline ACQ-5 Score at Week 24 in 5-11 Year Old Population
time frame: Baseline and Week 24
description: Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in 5-17 Year Old Population
time frame: Up to week 25
description: An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in 5-17 Year Old Population
time frame: Week 24
description: A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QT interval corrected (QTc).
measure: Change From Baseline in Fasting Glucose in 5-17 Year Old Population
time frame: Baseline and Week 24
description: Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).
measure: Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-17 Year Old Population
time frame: Up to week 24
description: Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
measure: Number of Participants With AEs and SAEs in 5-11 Year Old Population
time frame: Up to week 25
description: An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/Standard of care (SOC) to prevent one of the other outcomes mentioned before.
measure: Number of Participants With Abnormal ECG Findings in 5-11 Year Old Population
time frame: Week 24
description: A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QTc.
measure: Change From Baseline in Fasting Glucose in 5-11 Year Old Population
time frame: Baseline and Week 24
description: Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).
measure: Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-11 Year Old Population
time frame: Up to week 24
description: Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
arm group label: Subjects receiving FF/VI in cohort A
arm group type: Experimental
description: Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 50/25 mcg administered once daily in the morning via ELLIPTA DPI.
arm group label: Subjects receiving FF in cohort A
arm group type: Active Comparator
description: Subjects will be randomized in 1:1 ratio to receive FF with a dose of 50 mcg administered once daily in the morning via ELLIPTA DPI.
arm group label: Subjects receiving FF/VI in cohort B
arm group type: Experimental
description: Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 100/25 mcg administered once daily in the morning via ELLIPTA DPI.
arm group label: Subjects receiving FF in cohort B
arm group type: Active Comparator
description: Subjects will be randomized in 1:1 ratio to receive FF with a dose of 100 mcg administered once daily in the morning via ELLIPTA DPI.
intervention type: Drug
intervention name: FF/VI via ELLIPTA DPI
description: ELLIPTA DPI inhaler will contain two individual blister strips; the first strip will contain FF(50 or 100 mcg) and second strip will contain VI (25 mcg).
arm group label: Subjects receiving FF/VI in cohort A
arm group label: Subjects receiving FF/VI in cohort B
intervention type: Drug
intervention name: FF via ELLIPTA DPI
description: ELLIPTA DPI inhaler will contain a single blister strip of FF (50 or 100 mcg).
arm group label: Subjects receiving FF in cohort A
arm group label: Subjects receiving FF in cohort B
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Argentina
country: Bulgaria
country: Canada
country: China
country: Germany
country: Hungary
country: Italy
country: Japan
country: Lithuania
country: Mexico
country: Poland
country: Romania
country: Russian Federation
country: South Africa
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com
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