<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/NCT03007914</url>
  </required_header>
  <id_info>
    <org_study_id>TCM for COPD Cohort</org_study_id>
    <nct_id>NCT03007914</nct_id>
  </id_info>
  <brief_title>Effect of Traditional Chinese Medicine on Outcomes in COPD Patients</brief_title>
  <official_title>A Multi-center, Prospective, Cohort Study to Evaluate the Effectiveness of Traditional Chinese Medicine on COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henan University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henan University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the effectiveness of the treatments in two cohort for&#xD;
      COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and&#xD;
      have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global&#xD;
      Initiative for Chronic Obstructive Lung Disease (GOLD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions&#xD;
      worldwide. Although many therapies exist and are being developed to relieve symptoms and&#xD;
      reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies&#xD;
      in highly selected populations. There are few clinical trials to compare therapeutic&#xD;
      alternatives in real world. Furthermore, some randomized controlled trials on comprehensive&#xD;
      TCM interventions, especially based on the TCM patterns, have been the certain evidence for&#xD;
      showing definite effect for COPD patients. In addition, studies in real world populations of&#xD;
      COPD that received different therapies that do have efficacy evidence was found wide&#xD;
      variations in care delivery. In short, there is a need for cohort study in COPD.&#xD;
&#xD;
      This is a multi-center, prospective, cohort study to evaluate the effectiveness of TCM on&#xD;
      COPD patients. The cohort study will enroll approximately 2540 patients that in two cohort,&#xD;
      one, TCM cohort, which have been evaluated and have certain effect; the other, conventional&#xD;
      medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung&#xD;
      Disease (GOLD).Subjects in two cohort will be followed-up 2 years.The primary outcome measure&#xD;
      is the frequency of exacerbations. The secondary efficacy measures include mortality rate and&#xD;
      all-cause mortality, FEV1, dyspnea (MMRC), exercise capacity( 6MWD), quality of life ( CAT,&#xD;
      SF-36 and COPD-PRO), and effectiveness satisfaction with treatment(ESQ-COPD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2020</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>The frequency of exacerbation</measure>
    <time_frame>Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>The all-cause mortality in 2 years of the follow up phase.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume in one second</measure>
    <time_frame>Change from Baseline in the one second (FEV1) at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.</time_frame>
    <description>FEV1 is the amount of air that can be exhaled in one second.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>Change from Baseline in MMRC at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.</time_frame>
    <description>Using Modified Medical Research Council (MMRC) scale to assess a patient's level of dyspnea. The MMRC scale is a simple grading system that scored from 0 (less severe) to 4 (severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minutes Walking Distance Test (6MWD)</measure>
    <time_frame>Change from Baseline in the 6MWD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COPD Assessment Test (CAT)</measure>
    <time_frame>Change from Baseline in the CAT at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.</time_frame>
    <description>Using the CAT to evaluate the impact of COPD on a person's life over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness satisfaction with treatment</measure>
    <time_frame>Change from Baseline in the ESQ-COPD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.</time_frame>
    <description>Using the effectiveness satisfaction questionnaire of chronic obstructive pulmonary disease (ESQ-COPD) to evaluate COPD patients' satisfaction with their treatment over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form 36-Item Health Survey (SF-36)</measure>
    <time_frame>Change from Baseline in the SF-36 at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.</time_frame>
    <description>Using the SF-36 to evaluate the impact of COPD on a person's life over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome for COPD (COPD-PRO)</measure>
    <time_frame>Change from Baseline in the COPD-PRO at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.</time_frame>
    <description>Using the COPD-PRO to evaluate the impact of COPD on a person's life over time.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2540</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>TCM cohort</arm_group_label>
    <description>Patients continue to receive the routine TCM treatments recommended by 2011 Chinese treatment guidelines of TCM for COPD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional medicine cohort</arm_group_label>
    <description>Patients continue to receive the conventional medicine recommended by 2014 GOLD and Chinese treatment guidelines for COPD.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The biological sample bank includes serum samples, plasma samples, sputum samples, urine&#xD;
      samples, stool samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        COPD patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A confirmed diagnosis of COPD.&#xD;
&#xD;
          -  Medically stable.&#xD;
&#xD;
          -  Age between 40 and 80 years.&#xD;
&#xD;
          -  Syndrome differentiation belongs to syndrome of deficiency of deficiency of lung qi,&#xD;
             deficiency of pulmonic-splenic qi, syndrome of insufficiency of qi of the lung and&#xD;
             kidney, syndrome of insufficiency of qi and yin of the lung and kidney.&#xD;
&#xD;
          -  With the informed consent signed.&#xD;
&#xD;
          -  Capable of complying with the dosing regimen and visit schedules.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Any psychiatric condition rendering the patient unable to understand the nature, scope&#xD;
             and possible consequences of the study.&#xD;
&#xD;
          -  Malignancy for which patient has undergone resection, radiation therapy or&#xD;
             chemotherapy within the last 5 years.&#xD;
&#xD;
          -  Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma,&#xD;
             tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).&#xD;
&#xD;
          -  Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within&#xD;
             six months ,or unstable hemodynamics.&#xD;
&#xD;
          -  Complicated with serious hepatic and renal diseases (liver cirrhosis, portal&#xD;
             hypertension, bleeding of varicose veins, dialysis, or renal transplantation).&#xD;
&#xD;
          -  Complicated with congenital or acquired immune deficiency.&#xD;
&#xD;
          -  Participating in other trials or allergic to the used medicine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiansheng Li, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital of Henan University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Xie, Doctor</last_name>
    <phone>+86 371 66248624</phone>
    <email>xieyanghn@163.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary Disease, Chronic Obstructive</keyword>
  <keyword>Medicine, Chinese Traditional</keyword>
  <keyword>Humans</keyword>
  <keyword>Treatment Outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03007914
org study id: TCM for COPD Cohort
nct id: NCT03007914
lead sponsor: 
has dmc: Yes
The aim of this study is to compare the effectiveness of the treatments in two cohort for
      COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and
      have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global
      Initiative for Chronic Obstructive Lung Disease (GOLD).
COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions
      worldwide. Although many therapies exist and are being developed to relieve symptoms and
      reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies
      in highly selected populations. There are few clinical trials to compare therapeutic
      alternatives in real world. Furthermore, some randomized controlled trials on comprehensive
      TCM interventions, especially based on the TCM patterns, have been the certain evidence for
      showing definite effect for COPD patients. In addition, studies in real world populations of
      COPD that received different therapies that do have efficacy evidence was found wide
      variations in care delivery. In short, there is a need for cohort study in COPD.

      This is a multi-center, prospective, cohort study to evaluate the effectiveness of TCM on
      COPD patients. The cohort study will enroll approximately 2540 patients that in two cohort,
      one, TCM cohort, which have been evaluated and have certain effect; the other, conventional
      medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung
      Disease (GOLD).Subjects in two cohort will be followed-up 2 years.The primary outcome measure
      is the frequency of exacerbations. The secondary efficacy measures include mortality rate and
      all-cause mortality, FEV1, dyspnea (MMRC), exercise capacity( 6MWD), quality of life ( CAT,
      SF-36 and COPD-PRO), and effectiveness satisfaction with treatment(ESQ-COPD).
observational model: Cohort
time perspective: Prospective
measure: The frequency of exacerbation
time frame: Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
measure: All cause mortality
time frame: The all-cause mortality in 2 years of the follow up phase.
measure: Forced expiratory volume in one second
time frame: Change from Baseline in the one second (FEV1) at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
description: FEV1 is the amount of air that can be exhaled in one second.
measure: Dyspnea
time frame: Change from Baseline in MMRC at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
description: Using Modified Medical Research Council (MMRC) scale to assess a patient's level of dyspnea. The MMRC scale is a simple grading system that scored from 0 (less severe) to 4 (severe).
measure: Minutes Walking Distance Test (6MWD)
time frame: Change from Baseline in the 6MWD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
measure: COPD Assessment Test (CAT)
time frame: Change from Baseline in the CAT at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
description: Using the CAT to evaluate the impact of COPD on a person's life over time.
measure: Effectiveness satisfaction with treatment
time frame: Change from Baseline in the ESQ-COPD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
description: Using the effectiveness satisfaction questionnaire of chronic obstructive pulmonary disease (ESQ-COPD) to evaluate COPD patients' satisfaction with their treatment over time.
measure: Short Form 36-Item Health Survey (SF-36)
time frame: Change from Baseline in the SF-36 at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
description: Using the SF-36 to evaluate the impact of COPD on a person's life over time.
measure: Patient reported outcome for COPD (COPD-PRO)
time frame: Change from Baseline in the COPD-PRO at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.
description: Using the COPD-PRO to evaluate the impact of COPD on a person's life over time.
arm group label: TCM cohort
description: Patients continue to receive the routine TCM treatments recommended by 2011 Chinese treatment guidelines of TCM for COPD.
arm group label: Conventional medicine cohort
description: Patients continue to receive the conventional medicine recommended by 2014 GOLD and Chinese treatment guidelines for COPD.
The biological sample bank includes serum samples, plasma samples, sputum samples, urine
      samples, stool samples.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jiansheng Li, Doctor
role: Study Chair
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
last name: Yang Xie, Doctor
phone: +86 371 66248624
email: xieyanghn@163.com
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Chronic Disease
sharing ipd: No