<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/NCT01687296</url>
  </required_header>
  <id_info>
    <org_study_id>114220</org_study_id>
    <nct_id>NCT01687296</nct_id>
  </id_info>
  <brief_title>Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma</brief_title>
  <official_title>A Multicentre, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group Study to Determine the Efficacy and Safety of Nebulized Fluticasone Propionate 1mg Twice Daily Compared With Oral Prednisone Administered for 7 Days to Chinese Pediatric and Adolescent Subjects (Aged 4 to 16 Years) With an Acute Exacerbation of Asthma</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicentre, randomized, double-blind, double-dummy, active-controlled,&#xD;
      parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate&#xD;
      1mg twice daily compared with oral prednisone administered for 7 days to Chinese pediatric&#xD;
      and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicentre, randomized, double-blind, double-dummy, active-controlled,&#xD;
      parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate&#xD;
      (FP) 1mg twice daily compared with oral prednisone administered for 7 days to Chinese&#xD;
      pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma.&#xD;
      This study is for supporting registration of FP Nebules treating Chinese pediatric and&#xD;
      adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma in China.&#xD;
&#xD;
      At least 250 subjects, aged 4-16 years old, diagnosed an acute exacerbation of asthma at&#xD;
      presentation, are eligible to take part in the study if they meet the inclusion criteria.&#xD;
      They are randomly assigned at the ratio 1:1 to one of the following treatment groups for 7&#xD;
      days: FP Nebules 2×0.5mg/2ml twice daily/Placebo tablets once daily; Or, Oral prednisone&#xD;
      tablets once daily (2mg/kg.day, up to 40mg/day for 4 days, then 1mg/kg.day or half of the&#xD;
      original dose, up to 20mg/day for 3 days) / Placebo Nebules 2×2ml 0.9% saline twice daily.&#xD;
      While all subjects are given Salbutamol Nebules / MDI for relief of symptoms. After&#xD;
      randomization (visit 1), the following visits are on Day5 (visit 2) and Day8 (visit 3), and a&#xD;
      follow-up phone call (visit4) will happen two weeks post treatment on Day 21 for collection&#xD;
      of adverse events.&#xD;
&#xD;
      The primary endpoint is mean morning PEF on diary card over the treatment assessment period.&#xD;
      The secondary endpoints include subject derived data (symptom scores ), evening PEF on diary&#xD;
      card, use of rescue medications, clinic assessments of pulmonary function ( FEV1, and FVC) ,&#xD;
      clinical scoring index , patient/parent and investigator global evaluation, and use of rescue&#xD;
      medications during the trial. Safety endpoints include AEs, vital signs, and oropharyngeal&#xD;
      examinations, and laboratory tests (haematology, urinalysis, chemistry). The subjects are&#xD;
      assessed for compliance on completion of diary card.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 12, 2012</start_date>
  <completion_date type="Actual">June 21, 2013</completion_date>
  <primary_completion_date type="Actual">June 1, 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population</measure>
    <time_frame>Days 2 to 8</time_frame>
    <description>PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population</measure>
    <time_frame>Days 2 to 8</time_frame>
    <description>PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Evening PEF on Diary Card Over the Treatment Assessment Period</measure>
    <time_frame>Days 1/2 to 8</time_frame>
    <description>PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem [PM]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period</measure>
    <time_frame>Days 2 to 8</time_frame>
    <description>The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period</measure>
    <time_frame>Days 2 to 8</time_frame>
    <description>The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period</measure>
    <time_frame>During the treatment period at Day 5, Day 8</time_frame>
    <description>Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8</measure>
    <time_frame>Baseline, Day 5 and Day 8</time_frame>
    <description>The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Global Evaluation for Efficacy by Participant/Parent and Investigator</measure>
    <time_frame>Day 8</time_frame>
    <description>At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">261</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>fluticasone Nebules/placebo tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2×0.5mg/2ml twice daily neblulized/placebo tablet, oral, once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oral prednisone/placebo inhalation solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>once daily (2mg/kg.day, up to 40mg/day for 4 days, then 1mg/kg.day or half of the original dose, up to 20mg/day for 3 days) / placebo inhalation solution nebulized twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluticasone propionate inhalation solution</intervention_name>
    <description>2×0.5mg/2ml twice daily nebulized to treat an acute exacerbation of asthma for 7 days</description>
    <arm_group_label>fluticasone Nebules/placebo tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral prednisone</intervention_name>
    <description>once daily (2mg/kg.day, up to 40mg/day for 4 days, then 1mg/kg.day or half of the original dose, up to 20mg/day for 3 days) to treat an acute exacerbation of asthma for 7 days</description>
    <arm_group_label>oral prednisone/placebo inhalation solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo inhalation solution</intervention_name>
    <description>4ml 0.9% saline nebulized twice daily</description>
    <arm_group_label>oral prednisone/placebo inhalation solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo tablet</intervention_name>
    <description>placebo soluble tablet, oral ,once daily</description>
    <arm_group_label>fluticasone Nebules/placebo tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>salbutamol</intervention_name>
    <description>Salbutamol MDI 2 puffs twice daily or Nebules twice daily, and can be increased up to every 4 hours on an as-needed basis, through the treatment period.</description>
    <arm_group_label>fluticasone Nebules/placebo tablet</arm_group_label>
    <arm_group_label>oral prednisone/placebo inhalation solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese male and female pediatric or adolescent subjects aged 4 to 16 years, inclusive&#xD;
&#xD;
          -  Subjects have an established diagnosis of asthma&#xD;
&#xD;
          -  The definition of asthma. According to Chinese Guideline for the diagnosis and optimal&#xD;
             management of asthma in children [Respiratory branch of pediatric society,Chinese&#xD;
             Medical. Association. 2008, revised version], the subjects can be diagnosed when&#xD;
             meeting the criteria. The diagnosis criteria is listed in the protocol.&#xD;
&#xD;
          -  The severity of an acute exacerbation of asthma is defined as PEF of 50% to 75%&#xD;
             predicted via a peak flow meter, with a clinical scoring index of ≥2. The clinical&#xD;
             scoring index represents the sum of the score for each of four signs: respiratory rate&#xD;
             (0=low to 3=high, dependent on age), wheezing (0=none to 3=severe),&#xD;
             inspiration/expiration ratio (0=2:1 to 3=1:3), and accessory muscle (0=none to&#xD;
             3=marked use).&#xD;
&#xD;
          -  Subjects can properly use a mini-wright peak flow meter, nebulizer and MDI&#xD;
             with/without a spacer, and accurately complete a diary card with parental assistance,&#xD;
             if required.&#xD;
&#xD;
          -  Subjects' parents/guardians are willing to give written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Severe respiratory dysfunction.&#xD;
&#xD;
          -  History of mechanical ventilation due to respiratory failure.&#xD;
&#xD;
          -  Admission to hospital due to respiratory disease within the previous 2 weeks,&#xD;
             including asthmatic exacerbations.&#xD;
&#xD;
          -  Clinical or lab evidence of a serious, uncontrolled systemic disease or presence of&#xD;
             any disease likely to interfere with the objectives of this study, such as pulmonary&#xD;
             cystic fibrosis and bronchopulmonary dysplasia.&#xD;
&#xD;
          -  Known or suspected hypersensitivity to glucocorticosteroids or β2 agonists.&#xD;
&#xD;
          -  Clinical visual evidence of oral candidiasis at Visit1.&#xD;
&#xD;
          -  Use of the medications below in Table 1 according to the following defined time&#xD;
             intervals prior to presentation. The list is provided in the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>16 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>Changsha</city>
        <state>Hunan</state>
        <zip>410005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Yanji</city>
        <state>Jilin</state>
        <zip>133000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>323027</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chongqing</city>
        <zip>400014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wuxi</city>
        <zip>214023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>February 10, 2017</results_first_submitted>
  <results_first_submitted_qc>July 6, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 30, 2018</results_first_posted>
  <last_update_submitted>June 18, 2018</last_update_submitted>
  <last_update_submitted_qc>June 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PEF</keyword>
  <keyword>inhaled</keyword>
  <keyword>Fluticasone Propionate</keyword>
  <keyword>safety</keyword>
  <keyword>prednisone</keyword>
  <keyword>acute exacerbation</keyword>
  <keyword>asthma</keyword>
  <keyword>efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Albuterol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was planned on 250 Chinese paediatric and adolescent participants (aged 4 to 16 years) with an acute exacerbation of asthma and was conducted at 11 centres in China from 12th November 2012 to 21st June 2013.</recruitment_details>
      <pre_assignment_details>A total of 266 participants (par) were screened for this study. Of these, 5 participants were screen failures. A total of 261 participants were randomized to receive either nebulized fluticasone or oral prednisone. A total of 251 participants received at least a single dose study drug.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fluticasone Propionate</title>
          <description>Participants received fluticasone propionate inhalation solution twice daily (BID) 2x0.5 milligrams (mg)/millilitres (mL) via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
        </group>
        <group group_id="P2">
          <title>Prednisone</title>
          <description>Participants received oral prednisone tablets once daily at 2 mg per kilogram (kg) per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fluticasone Propionate</title>
          <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
        </group>
        <group group_id="B2">
          <title>Prednisone</title>
          <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</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="123"/>
            <count group_id="B2" value="128"/>
            <count group_id="B3" value="251"/>
          </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="6.6" spread="2.41"/>
                    <measurement group_id="B2" value="6.5" spread="2.32"/>
                    <measurement group_id="B3" value="6.5" spread="2.36"/>
                  </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="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population</title>
        <description>PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group.</description>
        <time_frame>Days 2 to 8</time_frame>
        <population>ITT Population comprised of all participants randomized to treatment and who received at least one dose of study drug. Data is presented for the participants available at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate</title>
            <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Prednisone</title>
            <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population</title>
          <description>PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group.</description>
          <population>ITT Population comprised of all participants randomized to treatment and who received at least one dose of study drug. Data is presented for the participants available at the time of assessment.</population>
          <units>Litres per minute (L/min)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188.77" spread="3.774"/>
                    <measurement group_id="O2" value="188.31" spread="3.790"/>
                  </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>250 par were to be enrolled to achieve 200 total evaluable par or 100 evaluable par per group. Sample size was based on the primary efficacy endpoint (AM PEF) and had 80% power to reject the null hypothesis: nebulized FP (1 mg BID) was inferior to oral prednisone with regard to AM PEF using one-side t test at significance level 2.5%, and assuming true treatment difference (FP minus predisone) was 3.6 L/min, noninferiority margin was -12L/min, and common standard deviation was 39 L/min.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.</non_inferiority_desc>
            <p_value>0.931</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.85</ci_lower_limit>
            <ci_upper_limit>10.76</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population</title>
        <description>PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group.</description>
        <time_frame>Days 2 to 8</time_frame>
        <population>PP Population comprised of all participants in the ITT Population who did not have any full protocol violations which could impact treatment effect. Data is presented for the participants available at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate</title>
            <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Prednisone</title>
            <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population</title>
          <description>PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group.</description>
          <population>PP Population comprised of all participants in the ITT Population who did not have any full protocol violations which could impact treatment effect. Data is presented for the participants available at the time of assessment.</population>
          <units>L/min</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189.46" spread="3.724"/>
                    <measurement group_id="O2" value="188.96" spread="3.712"/>
                  </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>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.</non_inferiority_desc>
            <p_value>0.922</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.64</ci_lower_limit>
            <ci_upper_limit>10.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Evening PEF on Diary Card Over the Treatment Assessment Period</title>
        <description>PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem [PM]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group.</description>
        <time_frame>Days 1/2 to 8</time_frame>
        <population>ITT Population. Data is presented for the participants available at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate</title>
            <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Prednisone</title>
            <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Evening PEF on Diary Card Over the Treatment Assessment Period</title>
          <description>PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem [PM]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group.</description>
          <population>ITT Population. Data is presented for the participants available at the time of assessment.</population>
          <units>L/min</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="195.79" spread="3.723"/>
                    <measurement group_id="O2" value="194.63" spread="3.751"/>
                  </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 or Other</non_inferiority_type>
            <p_value>0.822</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.02</ci_lower_limit>
            <ci_upper_limit>11.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period</title>
        <description>The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period.</description>
        <time_frame>Days 2 to 8</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate</title>
            <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Prednisone</title>
            <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period</title>
          <description>The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period.</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day-time symptom score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                    <count group_id="O2" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Night-time symptom score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0" upper_limit="4"/>
                  </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>Fluticasone propionate versus Prednisone for day-time symptom score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.717</p_value>
            <method>Wilcoxon rank sum test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fluticasone propionate versus Prednisone for night-time symptom score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.683</p_value>
            <method>Wilcoxon rank sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period</title>
        <description>The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period.</description>
        <time_frame>Days 2 to 8</time_frame>
        <population>ITT Population. Data is presented for the participants available at the time of assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate</title>
            <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Prednisone</title>
            <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period</title>
          <description>The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period.</description>
          <population>ITT Population. Data is presented for the participants available at the time of assessment.</population>
          <units>Number of use of rescue medication</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="2.0" lower_limit="0" upper_limit="3"/>
                  </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 or Other</non_inferiority_type>
            <p_value>0.996</p_value>
            <method>Wilcoxon rank sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period</title>
        <description>Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment.</description>
        <time_frame>During the treatment period at Day 5, Day 8</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate</title>
            <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Prednisone</title>
            <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period</title>
          <description>Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment.</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed.</population>
          <units>Litres</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FEV1, Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.288" spread="0.0348"/>
                    <measurement group_id="O2" value="1.331" spread="0.0332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FEV1, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.400" spread="0.0294"/>
                    <measurement group_id="O2" value="1.396" spread="0.0280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FVC, Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.476" spread="0.0454"/>
                    <measurement group_id="O2" value="1.543" spread="0.0439"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FVC, Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.544" spread="0.0326"/>
                    <measurement group_id="O2" value="1.582" spread="0.0316"/>
                  </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>Fluticasone propionate versus Prednisone for FEV1 on Day 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.348</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.044</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.135</ci_lower_limit>
            <ci_upper_limit>0.048</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fluticasone propionate versus Prednisone for FEV1 on Day 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.914</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.004</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.074</ci_lower_limit>
            <ci_upper_limit>0.083</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fluticasone propionate versus Prednisone for FVC on Day 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.276</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.067</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.187</ci_lower_limit>
            <ci_upper_limit>0.054</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fluticasone propionate versus Prednisone for FVC on Day 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.384</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.039</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.126</ci_lower_limit>
            <ci_upper_limit>0.049</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8</title>
        <description>The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3</description>
        <time_frame>Baseline, Day 5 and Day 8</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate</title>
            <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Prednisone</title>
            <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8</title>
          <description>The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3</description>
          <population>ITT Population. Only those participants available at the specified time points were 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="123"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="1.41"/>
                    <measurement group_id="O2" value="-2.6" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="1.26"/>
                    <measurement group_id="O2" value="-3.4" spread="1.26"/>
                  </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>Fluticasone propionate versus Prednisone for clinical scoring index on Day 5</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.507</p_value>
            <method>Wilcoxon rank sum test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fluticasone propionate versus Prednisone for clinical scoring index on Day 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.700</p_value>
            <method>Wilcoxon rank sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Global Evaluation for Efficacy by Participant/Parent and Investigator</title>
        <description>At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis.</description>
        <time_frame>Day 8</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Propionate</title>
            <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Prednisone</title>
            <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Global Evaluation for Efficacy by Participant/Parent and Investigator</title>
          <description>At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis.</description>
          <population>ITT Population. Only those participants available at the specified time points were 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="123"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participant/parent global evaluation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="0.59"/>
                    <measurement group_id="O2" value="1.5" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Investigator global evaluation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                    <count group_id="O2" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="0.56"/>
                    <measurement group_id="O2" value="1.5" spread="0.52"/>
                  </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>Fluticasone propionate versus Prednisone for participant/parent global evaluation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.633</p_value>
            <method>Wilcoxon rank sum test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fluticasone propionate versus Prednisone for investigator global evaluation</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.323</p_value>
            <method>Wilcoxon rank sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>On- treatment serious adverse events (SAE) and non- serious adverse events (AE) were collected from start of study medication through the treatment phase up to 8 days (only on-treatment events captured).</time_frame>
      <desc>Safety Population comprised of participants randomized to treatment and who receive d at least one dose of study drug. Participants were assigned to the treatment group as per treatment actually received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fluticasone Propionate</title>
          <description>Participants received fluticasone propionate inhalation solution BID 2x0.5 mg/mL via a nebulizer in morning and evening for 7 days. Blinding was maintained by administration of placebo soluble tablets once daily in the morning for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
        </group>
        <group group_id="E2">
          <title>Prednisone</title>
          <description>Participants received oral prednisone tablets once daily at 2 mg per kg per day, up to 40 mg per day for 4 days, then 1 mg per kg per day or half of the original dose, up to 20 mg per day for 3 days in the morning. Blinding was maintained by administration of placebo nebules 2×2mL 0.9% saline BID in morning and evening for 7 days. Salbutamol was provided on a needed basis throughout the treatment period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</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="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA</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="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="128"/>
              </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>
    </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/NCT01687296
org study id: 114220
nct id: NCT01687296
lead sponsor: 
has dmc: No
This is a multicentre, randomized, double-blind, double-dummy, active-controlled,
      parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate
      1mg twice daily compared with oral prednisone administered for 7 days to Chinese pediatric
      and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma
This is a multicentre, randomized, double-blind, double-dummy, active-controlled,
      parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate
      (FP) 1mg twice daily compared with oral prednisone administered for 7 days to Chinese
      pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma.
      This study is for supporting registration of FP Nebules treating Chinese pediatric and
      adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma in China.

      At least 250 subjects, aged 4-16 years old, diagnosed an acute exacerbation of asthma at
      presentation, are eligible to take part in the study if they meet the inclusion criteria.
      They are randomly assigned at the ratio 1:1 to one of the following treatment groups for 7
      days: FP Nebules 2×0.5mg/2ml twice daily/Placebo tablets once daily; Or, Oral prednisone
      tablets once daily (2mg/kg.day, up to 40mg/day for 4 days, then 1mg/kg.day or half of the
      original dose, up to 20mg/day for 3 days) / Placebo Nebules 2×2ml 0.9% saline twice daily.
      While all subjects are given Salbutamol Nebules / MDI for relief of symptoms. After
      randomization (visit 1), the following visits are on Day5 (visit 2) and Day8 (visit 3), and a
      follow-up phone call (visit4) will happen two weeks post treatment on Day 21 for collection
      of adverse events.

      The primary endpoint is mean morning PEF on diary card over the treatment assessment period.
      The secondary endpoints include subject derived data (symptom scores ), evening PEF on diary
      card, use of rescue medications, clinic assessments of pulmonary function ( FEV1, and FVC) ,
      clinical scoring index , patient/parent and investigator global evaluation, and use of rescue
      medications during the trial. Safety endpoints include AEs, vital signs, and oropharyngeal
      examinations, and laboratory tests (haematology, urinalysis, chemistry). The subjects are
      assessed for compliance on completion of diary card.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population
time frame: Days 2 to 8
description: PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group.
measure: Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population
time frame: Days 2 to 8
description: PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group.
measure: Mean Evening PEF on Diary Card Over the Treatment Assessment Period
time frame: Days 1/2 to 8
description: PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem [PM]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group.
measure: Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period
time frame: Days 2 to 8
description: The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period.
measure: Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period
time frame: Days 2 to 8
description: The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period.
measure: Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period
time frame: During the treatment period at Day 5, Day 8
description: Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment.
measure: Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8
time frame: Baseline, Day 5 and Day 8
description: The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3
measure: Mean Global Evaluation for Efficacy by Participant/Parent and Investigator
time frame: Day 8
description: At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis.
arm group label: fluticasone Nebules/placebo tablet
arm group type: Experimental
description: 2×0.5mg/2ml twice daily neblulized/placebo tablet, oral, once daily
arm group label: oral prednisone/placebo inhalation solution
arm group type: Active Comparator
description: once daily (2mg/kg.day, up to 40mg/day for 4 days, then 1mg/kg.day or half of the original dose, up to 20mg/day for 3 days) / placebo inhalation solution nebulized twice daily
intervention type: Drug
intervention name: fluticasone propionate inhalation solution
description: 2×0.5mg/2ml twice daily nebulized to treat an acute exacerbation of asthma for 7 days
arm group label: fluticasone Nebules/placebo tablet
intervention type: Drug
intervention name: oral prednisone
description: once daily (2mg/kg.day, up to 40mg/day for 4 days, then 1mg/kg.day or half of the original dose, up to 20mg/day for 3 days) to treat an acute exacerbation of asthma for 7 days
arm group label: oral prednisone/placebo inhalation solution
intervention type: Drug
intervention name: placebo inhalation solution
description: 4ml 0.9% saline nebulized twice daily
arm group label: oral prednisone/placebo inhalation solution
intervention type: Drug
intervention name: placebo tablet
description: placebo soluble tablet, oral ,once daily
arm group label: fluticasone Nebules/placebo tablet
intervention type: Drug
intervention name: salbutamol
description: Salbutamol MDI 2 puffs twice daily or Nebules twice daily, and can be increased up to every 4 hours on an as-needed basis, through the treatment period.
arm group label: fluticasone Nebules/placebo tablet
arm group label: oral prednisone/placebo inhalation solution
criteria: 
gender: All
minimum age: 4 Years
maximum age: 16 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Asthma
mesh term: Fluticasone
mesh term: Xhance
mesh term: Prednisone
mesh term: Pharmaceutical Solutions
mesh term: Albuterol
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 