<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/NCT03804632</url>
  </required_header>
  <id_info>
    <org_study_id>D2287R00120</org_study_id>
    <nct_id>NCT03804632</nct_id>
  </id_info>
  <brief_title>Assessment of Asthma Control Level in Primary Care Setting in Malaysia</brief_title>
  <acronym>ASCOPE</acronym>
  <official_title>A Prospective Observational Multi Center Study to Assess the Level of Asthma Control at Government Health Clinics (Klinik Kesihatan) 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 prospective observational multi center study to assess the level of asthma control at&#xD;
      Primary Care Setting; government health clinics (Klinik Kesihatan) in Malaysia. The specific&#xD;
      objective of the study is to assess, in real-life clinical practice in Malaysia, the level of&#xD;
      asthma control and the potential risk factors for uncontrolled disease in asthma patients&#xD;
      treated at government health clinics.&#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 at&#xD;
      the Primary Care Setting in Malaysia which includes current clinical manifestation and future&#xD;
      risk of exacerbation. Given the lack of data on Asthma control level, the awareness on the&#xD;
      current disease control level will assist to properly characterise the patients based on GINA&#xD;
      control level thus leading to appropriate diagnosis and treatment. The specific objective of&#xD;
      the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined&#xD;
      asthma control and the potential risk factors for uncontrolled disease in asthma patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">June 6, 2018</completion_date>
  <primary_completion_date type="Actual">June 6, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of GINA-defined asthma control</measure>
    <time_frame>up to 8 months</time_frame>
    <description>GINA-defined asthma control: According to clinical characteristics that include daytime symptoms, limitations of activity, nocturnal symptoms/awakening, need for reliever/rescue treatment. Patient's are classified as controlled, partially controlled or uncontrolled.</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 is evaluated by patients' self-completion of the Asthma Control Test (ACT). The ACT is a reliable, valid tool that helps physicians identify patients with uncontrolled asthma in a clinical setting. The questionnaire assesses the frequency of asthma symptoms and patients' own perception of asthma control during the previous 4 weeks. Based on the sum of scores, complete asthma control (25 points), well-controlled asthma (20-24 points) or no asthma control (≤19 points) is revealed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence level in patients with inhalers</measure>
    <time_frame>up to 8 months</time_frame>
    <description>Adherence level measured by Malaysia Medication Adherence Scale (MALMAS)&#xD;
The first item of the MALMAS has five responses: (1) All the time, (2) Often, (3) Sometimes, (4) Rarely and (5) Never.&#xD;
The remaining seven items have a dichotomous response of &quot;Yes&quot; or &quot;No&quot;. The responses in the MALMAS were scored based on the MMAS-8 where the total score ranged from 0 to 8. Both instruments categorized medication adherence based on the total scores obtained: low adherence (total score&lt;6), medium adherence (6 to &lt; 8) and high adherence (total score = 8)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1011</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 October to December 2017 with age 18 and above</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatients seen and treated by health care providers at government health clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Malaysians who have been diagnosed with Asthma by a physician verified by an&#xD;
             investigator and seen at government health clinic (Klinik Kesihatan) from October -&#xD;
             December 2017&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical features suggesting emphysema or chronic bronchitis and other chronic lung&#xD;
             diagnosis&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Port Dickson</city>
        <state>Negeri Sembilan</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seremban</city>
        <state>Negeri Sembilan</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>George Town</city>
        <state>Penang</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pantai Remis</city>
        <state>Perak</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kota Kinabalu</city>
        <state>Sabah</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Asajaya</city>
        <state>Sarawak</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Banting</city>
        <state>Selangor</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rawang</city>
        <state>Selangor</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bandar Permaisuri</city>
        <state>Terengganu</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kuala Terengganu</city>
        <state>Terengganu</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=14738&amp;filename=ASCOPE_Synopsis_CTT.pdf</url>
    <description>CSR Synopsis</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>May 30, 2019</last_update_submitted>
  <last_update_submitted_qc>May 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2019</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>
  <!-- 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/NCT03804632
org study id: D2287R00120
nct id: NCT03804632
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective observational multi center study to assess the level of asthma control at
      Primary Care Setting; government health clinics (Klinik Kesihatan) in Malaysia. The specific
      objective of the study is to assess, in real-life clinical practice in Malaysia, the level of
      asthma control and the potential risk factors for uncontrolled disease in asthma patients
      treated at government health clinics.
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 at
      the Primary Care Setting 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: Prospective
measure: Level of GINA-defined asthma control
time frame: up to 8 months
description: GINA-defined asthma control: According to clinical characteristics that include daytime symptoms, limitations of activity, nocturnal symptoms/awakening, need for reliever/rescue treatment. Patient's are classified as controlled, partially controlled or uncontrolled.
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 is evaluated by patients' self-completion of the Asthma Control Test (ACT). The ACT is a reliable, valid tool that helps physicians identify patients with uncontrolled asthma in a clinical setting. The questionnaire assesses the frequency of asthma symptoms and patients' own perception of asthma control during the previous 4 weeks. Based on the sum of scores, complete asthma control (25 points), well-controlled asthma (20-24 points) or no asthma control (≤19 points) is revealed.
measure: Adherence level in patients with inhalers
time frame: up to 8 months
description: Adherence level measured by Malaysia Medication Adherence Scale (MALMAS)
The first item of the MALMAS has five responses: (1) All the time, (2) Often, (3) Sometimes, (4) Rarely and (5) Never.
The remaining seven items have a dichotomous response of "Yes" or "No". The responses in the MALMAS were scored based on the MMAS-8 where the total score ranged from 0 to 8. Both instruments categorized medication adherence based on the total scores obtained: low adherence (total score<6), medium adherence (6 to < 8) and high adherence (total score = 8)
arm group label: GINA-defined clinical diagnosis of Asthma
description: All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from October to December 2017 with age 18 and above
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Malaysia
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14738&filename=ASCOPE_Synopsis_CTT.pdf
description: CSR Synopsis
responsible party type: Sponsor
mesh term: Asthma