<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/NCT03273946</url>
  </required_header>
  <id_info>
    <org_study_id>207734</org_study_id>
    <nct_id>NCT03273946</nct_id>
  </id_info>
  <brief_title>Post-marketing Safety Monitoring Program of Fluticasone Propionate (FP) in Chinese Subjects With Asthma Aged 1 to &lt;4 Years</brief_title>
  <official_title>Post-Marketing Observational Study to Evaluate Safety Profile of Flixotide 50 μg pMDI Treatment in Chinese Subjects With Asthma Aged 1-&lt;4 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      For the prophylactic treatment of asthma, FP inhaled aerosol (Flixotide ®) administered via a&#xD;
      pressurized metered-dose inhaler (pMDI) was approved in China in adults, adolescents older&#xD;
      than 16 years of age and children aged 4 to 16 years. This post-marketing safety monitoring&#xD;
      program will evaluate the safety profile of FP 50 micrograms (µg) inhaled via a pediatric&#xD;
      spacer device with a face mask in Chinese subjects aged 1 to &lt;4 years. The adverse drug&#xD;
      reactions (ADRs) and predictors of these adverse reactions among subjects will be reported.&#xD;
      This single arm observational study will include subjects prescribed with FP 50 µg inhaled&#xD;
      via a pediatric spacer device with a face mask. The maximum duration of the study will be 12&#xD;
      weeks with 3 visits. Visit 1 (Day 1) will be on-site visit and will also mark the start of&#xD;
      the observational program. The follow-up visits will be scheduled at Visit 2 (Week 4), and&#xD;
      Visit 3 (Week 12) conducted on site or by telephone. A total of 150 asthmatic subjects who&#xD;
      have been prescribed FP 50 µg treatment for appropriate medical use for the first time in&#xD;
      China will be enrolled in the study. Flixotide is a registered trademark of GlaxoSmithKline&#xD;
      (GSK) group of companies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2018</start_date>
  <completion_date type="Actual">September 27, 2018</completion_date>
  <primary_completion_date type="Actual">September 27, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR)</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>An AE is defined as any untoward medical event which occurred in a participant or clinical study participant, which is temporally associated with the use of the medical product, whether or not considered related to the product. An ADR is defined as AE related to study drug and listed in the package insert. Number of participants who had at least one AE or ADR are presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, possible drug-induced liver injury or any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Number of participants who had at least one SAE or non-SAE are presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Any New, Unexpected AE or Safety Signal</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>An unexpected AE is defined as any adverse reaction whose nature and intensity have not been previously observed and documented for the study product (e.g. in the investigator brochure, product information). A safety signal is information on a new or known AE that may be caused by a medicine and requires further investigation. Number of participants with any new unexpected AE or safety signal are presented.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">158</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Subjects receiving fluticasone propionate</arm_group_label>
    <description>Eligible subjects will receive FP 50 µg twice daily inhaled via a pediatric pMDI with a face mask in clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone propionate</intervention_name>
    <description>Fluticasone propionate is an inhaled corticosteroid to be used via a pediatric spacer device with a face mask for prophylactic treatment of asthma.</description>
    <arm_group_label>Subjects receiving fluticasone propionate</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects aged between 1 to &lt;4, diagnosed with asthma, who have been prescribed FP 50 µg for&#xD;
        appropriate medical use for the first time in China will be included in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An appropriately signed and dated assent must be obtained from the parent/guardian of&#xD;
             the subject.&#xD;
&#xD;
          -  Subjects with 1 to &lt;4 years of age at Visit 1.&#xD;
&#xD;
          -  Subjects who have been prescribed Flixotide 50 µg for a medically appropriate use for&#xD;
             the first time will be included in this observational program; Flixotide 50 µg therapy&#xD;
             should be in line with the approved dosing: 50 to100 µg twice daily; subjects should&#xD;
             have the ability to inhale the doses via a pediatric spacer with a face mask&#xD;
             appropriately; subjects who have been exposed to Flixotide 50 µg, 125 µg and 250 µg&#xD;
             treatment previously will not be included.&#xD;
&#xD;
          -  The parent/guardian of the subject must provide reliable contact information which&#xD;
             includes home phone or cell phone for the follow up visits.&#xD;
&#xD;
          -  The parent/guardian of the subject must have the ability to comply study procedures.&#xD;
&#xD;
          -  Specific information regarding warnings, precautions, contraindications, AEs, and&#xD;
             other pertinent information on Flixotide 50 μg that may impact subject eligibility is&#xD;
             provided in the approved product label.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>4 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>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518038</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>Shanghai</city>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <results_first_submitted>September 9, 2019</results_first_submitted>
  <results_first_submitted_qc>September 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 2, 2019</results_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CCI18781</keyword>
  <keyword>Observational</keyword>
  <keyword>Post-marketing</keyword>
  <keyword>Fluticasone propionate</keyword>
  <keyword>Asthma</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>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03273946/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a single arm non-interventional, post-marketing safety monitoring study to evaluate safety of Chinese participants aged 1 to &lt;4 years when using Flixotide 50 micrograms (μg) via a pediatric spacer device with a face mask in clinical practice. No medical intervention was received by participants during conduct of this study.</recruitment_details>
      <pre_assignment_details>Total 158 participants were enrolled into this study. The study was conducted at 4 centers in China.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="158"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unwillingness of the guardian</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant refused to use the drug</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant relative refused to use drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="158"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.40" spread="10.98"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Region of Enrollment is reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>China</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>China</title>
                  <measurement_list>
                    <measurement group_id="B1" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR)</title>
        <description>An AE is defined as any untoward medical event which occurred in a participant or clinical study participant, which is temporally associated with the use of the medical product, whether or not considered related to the product. An ADR is defined as AE related to study drug and listed in the package insert. Number of participants who had at least one AE or ADR are presented.</description>
        <time_frame>Up to Week 12</time_frame>
        <population>Safety Analysis Population. It was defined as all the participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR)</title>
          <description>An AE is defined as any untoward medical event which occurred in a participant or clinical study participant, which is temporally associated with the use of the medical product, whether or not considered related to the product. An ADR is defined as AE related to study drug and listed in the package insert. Number of participants who had at least one AE or ADR are presented.</description>
          <population>Safety Analysis Population. It was defined as all the participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any ADR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE</title>
        <description>Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, possible drug-induced liver injury or any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Number of participants who had at least one SAE or non-SAE are presented.</description>
        <time_frame>Up to Week 12</time_frame>
        <population>Safety Analysis Population</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE</title>
          <description>Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, possible drug-induced liver injury or any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Number of participants who had at least one SAE or non-SAE are presented.</description>
          <population>Safety Analysis Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any non-SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Any New, Unexpected AE or Safety Signal</title>
        <description>An unexpected AE is defined as any adverse reaction whose nature and intensity have not been previously observed and documented for the study product (e.g. in the investigator brochure, product information). A safety signal is information on a new or known AE that may be caused by a medicine and requires further investigation. Number of participants with any new unexpected AE or safety signal are presented.</description>
        <time_frame>Up to Week 12</time_frame>
        <population>Safety Analysis Population</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any New, Unexpected AE or Safety Signal</title>
          <description>An unexpected AE is defined as any adverse reaction whose nature and intensity have not been previously observed and documented for the study product (e.g. in the investigator brochure, product information). A safety signal is information on a new or known AE that may be caused by a medicine and requires further investigation. Number of participants with any new unexpected AE or safety signal are presented.</description>
          <population>Safety Analysis Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any unexpected AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any safety signal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>In this non-interventional post-marketing safety monitoring study, non-SAEs and SAEs were collected up to Week 12 from start of the treatment in clinical practice. No medical intervention was received by participants during conduct of this study.</time_frame>
      <desc>Safety Analysis Population was used which included all participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>The observational study included participants aged 1 to less than 4 years, who have been prescribed Flixotide 50 μg (recommended dosing 50 to 100 μg twice daily inhaled via a pediatric spacer device with a face mask) for appropriate medical use for the first time in clinical practice. The maximum study duration was 12 weeks with 3 visits. No medical intervention was received by participants during conduct of this study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="104" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Ankyloglossia congenital</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pain abdominal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Stomach inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Indigestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Sensation of foreign body</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal hepatic function</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </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="47" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Herpangina</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Rhinopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Mycoplasma infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Herpes pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Molluscum contagious</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Parotitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Red blood cells urine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Coughing</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Urticarial rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

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


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03273946
org study id: 207734
nct id: NCT03273946
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
For the prophylactic treatment of asthma, FP inhaled aerosol (Flixotide ®) administered via a
      pressurized metered-dose inhaler (pMDI) was approved in China in adults, adolescents older
      than 16 years of age and children aged 4 to 16 years. This post-marketing safety monitoring
      program will evaluate the safety profile of FP 50 micrograms (µg) inhaled via a pediatric
      spacer device with a face mask in Chinese subjects aged 1 to <4 years. The adverse drug
      reactions (ADRs) and predictors of these adverse reactions among subjects will be reported.
      This single arm observational study will include subjects prescribed with FP 50 µg inhaled
      via a pediatric spacer device with a face mask. The maximum duration of the study will be 12
      weeks with 3 visits. Visit 1 (Day 1) will be on-site visit and will also mark the start of
      the observational program. The follow-up visits will be scheduled at Visit 2 (Week 4), and
      Visit 3 (Week 12) conducted on site or by telephone. A total of 150 asthmatic subjects who
      have been prescribed FP 50 µg treatment for appropriate medical use for the first time in
      China will be enrolled in the study. Flixotide is a registered trademark of GlaxoSmithKline
      (GSK) group of companies.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR)
time frame: Up to Week 12
description: An AE is defined as any untoward medical event which occurred in a participant or clinical study participant, which is temporally associated with the use of the medical product, whether or not considered related to the product. An ADR is defined as AE related to study drug and listed in the package insert. Number of participants who had at least one AE or ADR are presented.
measure: Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE
time frame: Up to Week 12
description: Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, possible drug-induced liver injury or any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Number of participants who had at least one SAE or non-SAE are presented.
measure: Number of Participants With Any New, Unexpected AE or Safety Signal
time frame: Up to Week 12
description: An unexpected AE is defined as any adverse reaction whose nature and intensity have not been previously observed and documented for the study product (e.g. in the investigator brochure, product information). A safety signal is information on a new or known AE that may be caused by a medicine and requires further investigation. Number of participants with any new unexpected AE or safety signal are presented.
arm group label: Subjects receiving fluticasone propionate
description: Eligible subjects will receive FP 50 µg twice daily inhaled via a pediatric pMDI with a face mask in clinical practice.
intervention type: Drug
intervention name: Fluticasone propionate
description: Fluticasone propionate is an inhaled corticosteroid to be used via a pediatric spacer device with a face mask for prophylactic treatment of asthma.
arm group label: Subjects receiving fluticasone propionate
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 4 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Asthma
mesh term: Fluticasone
mesh term: Xhance
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 