<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/NCT02219360</url>
  </required_header>
  <id_info>
    <org_study_id>2014-K-115</org_study_id>
    <nct_id>NCT02219360</nct_id>
  </id_info>
  <brief_title>Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease</brief_title>
  <acronym>TripAE</acronym>
  <official_title>Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chao Yang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease has become a serious global health care and public&#xD;
      health problems due to its high prevalence, high morbidity and heavy economic burden. Acute&#xD;
      exacerbation of chronic obstructive pulmonary disease is one of the most important causes of&#xD;
      death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD&#xD;
      exacerbations. In clinical practice for the treatment of acute exacerbation of COPD，&#xD;
      antibiotic application is still controversial. Evidence from current guideline is based on&#xD;
      strict criteria from randomized controlled trials, thus the given condition is simplified.&#xD;
      Patients meet the criteria account for the minority in the real world. Therefore, it is still&#xD;
      not clear whether most patients benefit from the recommended treatment. In our design,&#xD;
      hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment,&#xD;
      arterial hypoxemia, recovery time and length of hospitalization being observed. The main&#xD;
      purpose is to evaluate the benefit effect of current recommended treatment of acute&#xD;
      exacerbation of COPD in the real world.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease has become a serious global health care and public&#xD;
      health problems due to its high prevalence, high morbidity and heavy economic burden. Acute&#xD;
      exacerbation of COPD is one of the most important causes of death in patients with COPD. The&#xD;
      global strategy for the diagnosis, management, and prevention of COPD recommends systemic&#xD;
      corticosteroids therapy in COPD exacerbations as it can shorten recovery time, reduce&#xD;
      treatment failure, improve lung function and arterial hypoxemia. In clinical practice for the&#xD;
      treatment of acute exacerbation of COPD， antibiotic application is still controversial.&#xD;
      Evidence from current guideline is based on strict criteria from randomized controlled&#xD;
      trials, thus the given condition is simplified. Patients meet the criteria account for the&#xD;
      minority in the real world. Therefore, it is still not clear whether most patients benefit&#xD;
      from the recommended treatment. In our design, hospitalized patients with acute exacerbation&#xD;
      of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length&#xD;
      of hospitalization being observed. The main purpose is to evaluate the benefit effect of&#xD;
      current recommended treatment of acute exacerbation of COPD in the real world.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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>change of the score of COPD Assesment Test as a measurement of the overall condition of the patient</measure>
    <time_frame>baseline, 1 month after dischahge, 2 months after discharge</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of the score of modified Medical British Research Council questionaire as a measurement of the overall condition of the patient</measure>
    <time_frame>baseline, 1 month after discharge, 2 months after discharge</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>percentage of use of systemic corticosteroid in patients</measure>
    <time_frame>8 months after the first enrollment</time_frame>
  </other_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      25-(OH)-VD3 and glycated albumin will be tested&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease from&#xD;
        1st July, 2014 from Beijing Chao Yang Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Age≥ 40years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The first diagnosis which caused hospitalization is not acute exacerbation of chronic&#xD;
             obstructive pulmonary disease&#xD;
&#xD;
          -  Chest radiography shows congestive heart failure&#xD;
&#xD;
          -  Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism&#xD;
             or interstitial lung diseases&#xD;
&#xD;
          -  Serious cardiac failure, renal insufficiency or hepatic dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wang Ying, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chao Yang Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huang Kewu, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Beijing Chao Yang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Huang Kewu, M.D.</last_name>
    <phone>86-10-85231167</phone>
    <email>kewuhuang@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wang Ying, Master</last_name>
    <phone>86-0-13426121753</phone>
    <email>kokosalaki1020@gmail.com</email>
  </overall_contact_backup>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Wang Ying</investigator_full_name>
    <investigator_title>resident</investigator_title>
  </responsible_party>
  <keyword>acute</keyword>
  <keyword>exacerbation</keyword>
  <keyword>chronic obstructive pulmonary disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02219360
org study id: 2014-K-115
nct id: NCT02219360
lead sponsor: 
has dmc: No
Chronic obstructive pulmonary disease has become a serious global health care and public
      health problems due to its high prevalence, high morbidity and heavy economic burden. Acute
      exacerbation of chronic obstructive pulmonary disease is one of the most important causes of
      death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD
      exacerbations. In clinical practice for the treatment of acute exacerbation of COPD，
      antibiotic application is still controversial. Evidence from current guideline is based on
      strict criteria from randomized controlled trials, thus the given condition is simplified.
      Patients meet the criteria account for the minority in the real world. Therefore, it is still
      not clear whether most patients benefit from the recommended treatment. In our design,
      hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment,
      arterial hypoxemia, recovery time and length of hospitalization being observed. The main
      purpose is to evaluate the benefit effect of current recommended treatment of acute
      exacerbation of COPD in the real world.
Chronic obstructive pulmonary disease has become a serious global health care and public
      health problems due to its high prevalence, high morbidity and heavy economic burden. Acute
      exacerbation of COPD is one of the most important causes of death in patients with COPD. The
      global strategy for the diagnosis, management, and prevention of COPD recommends systemic
      corticosteroids therapy in COPD exacerbations as it can shorten recovery time, reduce
      treatment failure, improve lung function and arterial hypoxemia. In clinical practice for the
      treatment of acute exacerbation of COPD， antibiotic application is still controversial.
      Evidence from current guideline is based on strict criteria from randomized controlled
      trials, thus the given condition is simplified. Patients meet the criteria account for the
      minority in the real world. Therefore, it is still not clear whether most patients benefit
      from the recommended treatment. In our design, hospitalized patients with acute exacerbation
      of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length
      of hospitalization being observed. The main purpose is to evaluate the benefit effect of
      current recommended treatment of acute exacerbation of COPD in the real world.
observational model: Case-Only
time perspective: Prospective
measure: change of the score of COPD Assesment Test as a measurement of the overall condition of the patient
time frame: baseline, 1 month after dischahge, 2 months after discharge
measure: change of the score of modified Medical British Research Council questionaire as a measurement of the overall condition of the patient
time frame: baseline, 1 month after discharge, 2 months after discharge
measure: percentage of use of systemic corticosteroid in patients
time frame: 8 months after the first enrollment
25-(OH)-VD3 and glycated albumin will be tested
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Wang Ying, Master
role: Principal Investigator
affiliation: Beijing Chao Yang Hospital
last name: Huang Kewu, M.D.
role: Study Chair
affiliation: Beijing Chao Yang Hospital
last name: Huang Kewu, M.D.
phone: 86-10-85231167
email: kewuhuang@126.com
last name: Wang Ying, Master
phone: 86-0-13426121753
email: kokosalaki1020@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Wang Ying
investigator title: resident
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive