<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/NCT03295331</url>
  </required_header>
  <id_info>
    <org_study_id>D2287R00116</org_study_id>
    <nct_id>NCT03295331</nct_id>
  </id_info>
  <brief_title>Assessment of Asthma Control Level in Malaysia</brief_title>
  <acronym>ASCORE</acronym>
  <official_title>A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults at 2 Tertiary Care Centres In Malaysia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults&#xD;
      at 2 Tertiary Care Centres In Malaysia; Institute Of Respiratory Medicine (IPR) And Hospital&#xD;
      Serdang. The specific objective of the study is to assess, in real-life clinical practice in&#xD;
      Malaysia, the level of GINA-defined asthma control and the potential risk factors for&#xD;
      uncontrolled disease in asthma patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the availability of GINA global guideline on asthma management which is widely&#xD;
      referred by health care providers in Malaysia, the control of asthma is still a critical&#xD;
      challenge. According to National Health and Morbidity Survey 2011, the prevalence of asthma&#xD;
      in Malaysia is at 6.3%. Based on self-rated health status, 5.5% of patients were reported to&#xD;
      be in good health whereas 9.9% reported poor health status although medications such as&#xD;
      inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) are widely available for&#xD;
      effective asthma management. There is limited data to assess the level of asthma control in&#xD;
      Malaysia which includes current clinical manifestation and future risk of exacerbation. Given&#xD;
      the lack of data on Asthma control level, the awareness on the current disease control level&#xD;
      will assist to properly characterise the patients based on GINA control level thus leading to&#xD;
      appropriate diagnosis and treatment. The specific objective of the study is to assess, in&#xD;
      real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the&#xD;
      potential risk factors for uncontrolled disease in asthma patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">April 5, 2017</completion_date>
  <primary_completion_date type="Actual">April 5, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of GINA-defined asthma control</measure>
    <time_frame>up to 8 months</time_frame>
    <description>To assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Types of medication prescribed for asthma control</measure>
    <time_frame>up to 8 months</time_frame>
    <description>Pharmacological management used for asthma control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma control level</measure>
    <time_frame>up to 8 months</time_frame>
    <description>Asthma control level measured by Asthma Control Test (ACT) score</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">398</enrollment>
  <condition>Asthma Control Level</condition>
  <arm_group>
    <arm_group_label>GINA-defined clinical diagnosis of Asthma</arm_group_label>
    <description>All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from January to August 2016 with age 18 and above</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Tertiary Care Centre ( patients seen at outpatient physicians )&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic&#xD;
             from January to August 2016.&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical features suggesting emphysema or chronic bronchitis&#xD;
&#xD;
          -  Other de-compensated organ failures&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Serdang</name>
      <address>
        <city>Kajang</city>
        <state>Selangor</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Perubatan Respiratori</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wilayah Persekutuan Kuala Lumpur</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=4574&amp;filename=ASCORE_Abstract.pdf</url>
    <description>CSR Synopsis</description>
  </link>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>N/A, Non interventional Study , observational study. No patient involved</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03295331
org study id: D2287R00116
nct id: NCT03295331
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults
      at 2 Tertiary Care Centres In Malaysia; Institute Of Respiratory Medicine (IPR) And Hospital
      Serdang. The specific objective of the study is to assess, in real-life clinical practice in
      Malaysia, the level of GINA-defined asthma control and the potential risk factors for
      uncontrolled disease in asthma patients
Despite the availability of GINA global guideline on asthma management which is widely
      referred by health care providers in Malaysia, the control of asthma is still a critical
      challenge. According to National Health and Morbidity Survey 2011, the prevalence of asthma
      in Malaysia is at 6.3%. Based on self-rated health status, 5.5% of patients were reported to
      be in good health whereas 9.9% reported poor health status although medications such as
      inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) are widely available for
      effective asthma management. There is limited data to assess the level of asthma control in
      Malaysia which includes current clinical manifestation and future risk of exacerbation. Given
      the lack of data on Asthma control level, the awareness on the current disease control level
      will assist to properly characterise the patients based on GINA control level thus leading to
      appropriate diagnosis and treatment. The specific objective of the study is to assess, in
      real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the
      potential risk factors for uncontrolled disease in asthma patients
observational model: Case-Only
time perspective: Retrospective
measure: Level of GINA-defined asthma control
time frame: up to 8 months
description: To assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients
measure: Types of medication prescribed for asthma control
time frame: up to 8 months
description: Pharmacological management used for asthma control
measure: Asthma control level
time frame: up to 8 months
description: Asthma control level measured by Asthma Control Test (ACT) score
arm group label: GINA-defined clinical diagnosis of Asthma
description: All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from January to August 2016 with age 18 and above
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Malaysia
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4574&filename=ASCORE_Abstract.pdf
description: CSR Synopsis
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No
ipd description: N/A, Non interventional Study , observational study. No patient involved