<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/NCT01693471</url>
  </required_header>
  <id_info>
    <org_study_id>SEARCH-2012</org_study_id>
    <nct_id>NCT01693471</nct_id>
  </id_info>
  <brief_title>Survey on the Effect of Health Related Quality of Life (QOL) Associated With Compliance of Carbocisteine in Asthma Patients</brief_title>
  <official_title>Survey on the Effect of Health Related QOL Associated With Compliance of Carbocisteine in Asthma Patients Study (SEARCH Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyorin Pharmaceutical Co.,Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyorin Pharmaceutical Co.,Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting&#xD;
      from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients&#xD;
      whose control levels are partly controlled or uncontrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Period: 2012-2013 Observation Time: 0 week, 4 week&#xD;
&#xD;
      Matters investigated:&#xD;
&#xD;
        1. QOL determination using SF-36 v2&#xD;
&#xD;
        2. Medication compliance (VAS scale)&#xD;
&#xD;
        3. Gender, age, diagnosis, asthma subtype, severity, duration of disease, level of asthma&#xD;
           control, concomitant drugs, comorbidities, smoking, alcohol, work&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Score of SF-36</measure>
    <time_frame>4 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>HR-QOL condition of asthma patients with phlegm</measure>
    <time_frame>0 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication compliance: measured by patient response to visual analog scale</measure>
    <time_frame>4 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between a medication compliance measured by patient response to visual analog scale and change of HR-QOL from baseline at 4 weeks</measure>
    <time_frame>0 week, 4 week</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">179</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>SEARCH Study Group</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        General Practitioner&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients ≥ 20 years of age&#xD;
&#xD;
          -  Outpatients&#xD;
&#xD;
          -  Patients with mild or moderate persistent asthma&#xD;
&#xD;
          -  Patients with phlegm&#xD;
&#xD;
          -  Patients whose levels of asthma control are partly controlled or uncontrolled&#xD;
&#xD;
          -  Patients who are planned to treat MUCODYNE&#xD;
&#xD;
          -  Patients who voluntarily submitted written consent forms upon participation in this&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of adverse reactions to carbocisteine&#xD;
&#xD;
          -  Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease&#xD;
&#xD;
          -  Patients with the possibility of pregnancy or suspected pregnancy&#xD;
&#xD;
          -  Patients with complication of malignancy&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Patients with definitive diagnosis for COPD&#xD;
&#xD;
          -  Other patients whom investigators or subinvestigators considered inappropriate to&#xD;
             participate in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akito Saegusa, Mr.</last_name>
    <role>Study Chair</role>
    <affiliation>Kyorin Pharmaceutical Co.,Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Senzoku Respiratory Disease and Allergy Clinic</name>
      <address>
        <city>Ota-ku</city>
        <state>Tokyo</state>
        <zip>145-0063</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>February 27, 2013</last_update_submitted>
  <last_update_submitted_qc>February 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 1, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>SF-36</keyword>
  <keyword>HRQOL</keyword>
  <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/NCT01693471
org study id: SEARCH-2012
nct id: NCT01693471
lead sponsor: 
has dmc: No
The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting
      from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients
      whose control levels are partly controlled or uncontrolled.
Period: 2012-2013 Observation Time: 0 week, 4 week

      Matters investigated:

        1. QOL determination using SF-36 v2

        2. Medication compliance (VAS scale)

        3. Gender, age, diagnosis, asthma subtype, severity, duration of disease, level of asthma
           control, concomitant drugs, comorbidities, smoking, alcohol, work
observational model: Cohort
time perspective: Prospective
measure: Score of SF-36
time frame: 4 week
measure: HR-QOL condition of asthma patients with phlegm
time frame: 0 week
measure: Medication compliance: measured by patient response to visual analog scale
time frame: 4 week
measure: Relation between a medication compliance measured by patient response to visual analog scale and change of HR-QOL from baseline at 4 weeks
time frame: 0 week, 4 week
arm group label: SEARCH Study Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Akito Saegusa, Mr.
role: Study Chair
affiliation: Kyorin Pharmaceutical Co.,Ltd
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Asthma