<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/NCT03015090</url>
  </required_header>
  <id_info>
    <org_study_id>2016D01C013</org_study_id>
    <nct_id>NCT03015090</nct_id>
  </id_info>
  <brief_title>Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline</brief_title>
  <official_title>Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline in Han and Uygur Patients With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>XiaoGuang Zou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southern Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kashgar 1st People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect&#xD;
      metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary&#xD;
      disease patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentrations of theophylline</measure>
    <time_frame>one week</time_frame>
    <description>Blood samples will be taken after receiving oral theophylline</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>theophylline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Theophylline</intervention_name>
    <description>After oral theophylline 200mg per day for one week, blood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2</description>
    <arm_group_label>theophylline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-75 years,Weight 40-80kg COPD patients, male or female; regularly visiting our&#xD;
             hospital; taking a sustained-release preparation of theophylline continuously for at&#xD;
             least 2 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with renal or hepatic dysfunction; Patients with congestive heart failure;&#xD;
             Patients with hypothyroidism or hyperthyroidism; Patients currently taking drugs&#xD;
             likely to effect theophylline metabolism or who had taken such drugs in the preceding&#xD;
             week; Patients with extreme obesity Patients with very severe Chronic Obstructive&#xD;
             Pulmonary Disease(COPD)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kashgar 1st People's Hospital</name>
      <address>
        <city>Kashgar</city>
        <state>Xinjiang</state>
        <zip>844000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>March 2, 2022</last_update_submitted>
  <last_update_submitted_qc>March 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kashgar 1st People's Hospital</investigator_affiliation>
    <investigator_full_name>XiaoGuang Zou</investigator_full_name>
    <investigator_title>Professor of Pharmacy</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>CYP1A2</keyword>
  <keyword>Theophylline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Theophylline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </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/NCT03015090
org study id: 2016D01C013
nct id: NCT03015090
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect
      metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary
      disease patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Plasma concentrations of theophylline
time frame: one week
description: Blood samples will be taken after receiving oral theophylline
arm group label: theophylline
arm group type: Experimental
intervention type: Drug
intervention name: Theophylline
description: After oral theophylline 200mg per day for one week, blood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2
arm group label: theophylline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Kashgar 1st People's Hospital
investigator full name: XiaoGuang Zou
investigator title: Professor of Pharmacy
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Theophylline
sharing ipd: Yes