<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/NCT03237221</url>
  </required_header>
  <id_info>
    <org_study_id>CTVA-China</org_study_id>
    <nct_id>NCT03237221</nct_id>
  </id_info>
  <brief_title>Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma</brief_title>
  <official_title>Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that&#xD;
      threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of&#xD;
      breath, chest tightness and cough, usually occurring at night or early morning. However,&#xD;
      there are still some patients with only persistent clinical manifestations of chest&#xD;
      tightness. Concerned about this group of patients, we presented a subgroup of bronchial&#xD;
      asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks&#xD;
      asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and&#xD;
      therefore often misdiagnosed for a long time. In order to further understand the clinical&#xD;
      characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national&#xD;
      multicenter observation study to further understand CTVA. Finally, we plan to clarify whether&#xD;
      CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and&#xD;
      perform an appropriate treatment of CTVA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">October 23, 2020</completion_date>
  <primary_completion_date type="Actual">December 12, 2019</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>Asthma control questionnaire (ACQ)</measure>
    <time_frame>Change from Baseline ACQ score at 36 months</time_frame>
    <description>Asthma control questionnaire (ACQ)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume in one second</measure>
    <time_frame>Change from Baseline ACQ score at 36 months</time_frame>
    <description>Forced expiratory volume in one second</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway responsiveness</measure>
    <time_frame>Change from Baseline ACQ score at 36 months</time_frame>
    <description>Airway responsiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak expiratory flow</measure>
    <time_frame>Change from Baseline ACQ score at 36 months</time_frame>
    <description>Peak expiratory flow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma quality of life questionnaire</measure>
    <time_frame>Change from Baseline ACQ score at 36 months</time_frame>
    <description>Asthma quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute asthma episode</measure>
    <time_frame>Change from Baseline ACQ score at 36 months</time_frame>
    <description>Acute asthma episode</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of emergency or hospitalization</measure>
    <time_frame>Change from Baseline ACQ score at 36 months</time_frame>
    <description>Numbers of emergency or hospitalization</description>
  </secondary_outcome>
  <enrollment type="Actual">76</enrollment>
  <condition>Asthma</condition>
  <condition>Chest Syndrome</condition>
  <condition>Clinical Anxiety</condition>
  <condition>Clinical Depression</condition>
  <condition>Lung Function</condition>
  <condition>Quality of Life</condition>
  <condition>Eosinophilia</condition>
  <condition>Nitric Oxide</condition>
  <condition>Airway Responsiveness</condition>
  <condition>Induced Sputum</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treat patient according to Global Initiative for Asthma (GINA) guideline</intervention_name>
    <description>Treat patient according to Global Initiative for Asthma (GINA) guideline</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with only symptom of chest tightness and bronchial provocation test positive&#xD;
        according to eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. all subjects agreed to participate, understand the project, observe the use of drugs,&#xD;
             agree to follow-up, and signed informed consent;&#xD;
&#xD;
          2. the age of more than 14 and less 80 years old, gender and ethnicity are not limited;&#xD;
&#xD;
          3. the duration time was more than 6 months,and chest tightness was the only complaint,&#xD;
             without breathing, short of breath, chronic cough;&#xD;
&#xD;
          4. no wheezing;&#xD;
&#xD;
          5. a diagnosis of asthma supported by one or more other characteristics:&#xD;
&#xD;
               -  bronchial provocation test positive;&#xD;
&#xD;
               -  improvement in forced expiratory volume at one second (FEV1) of more than 12% and&#xD;
                  200 mL after inhaled salbutamol;&#xD;
&#xD;
               -  variability in diurnal peak expiratory flow (PEF) of more than 10% for one day&#xD;
                  during one week.&#xD;
&#xD;
          6. bronchodilator and glucocorticoid treatment is effective;&#xD;
&#xD;
          7. exclude the following diseases by the corresponding doctors: coronary heart disease,&#xD;
             myocarditis, heart failure, GERD, neuromuscular disease, and mental disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. can not cooperate with related inspection or for other reasons;&#xD;
&#xD;
          2. patients with chronic obstructive pulmonary disease, interstitial pneumonia, active&#xD;
             tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor&#xD;
             pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such&#xD;
             as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux&#xD;
             disease, neuromuscular disease, etc);&#xD;
&#xD;
          3. history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness&#xD;
             (schizophrenia, obsessive-compulsive disorder, depression) and against personality,&#xD;
             motivation, suspicious, or other emotional or mental issues that may affect&#xD;
             participation in the study;&#xD;
&#xD;
          4. taking part in other drug clinical trial project, or drop out less than 3 months;&#xD;
&#xD;
          5. during pregnancy, lactation women;&#xD;
&#xD;
          6. obvious abnormal of High Resolution CT.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huahao Shen</last_name>
    <role>Study Chair</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Chao-Yang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Tongren Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China-Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinqiao Hospital，Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital，Fujian Medical University</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital, Nanfang Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital,Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Shenzhen</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital,Zhanjiang Medical College</name>
      <address>
        <city>Zhanjiang</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guizhou Provincial People's Hospital</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Central Hospital of Shenyang Military</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Provincal Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qingdao Municipal Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weifang Asthma Hospital</name>
      <address>
        <city>Weifang</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yantai liuhuanding Hospital</name>
      <address>
        <city>Yantai</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital, Second Military Medical University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.1 Hospital, Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital, Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital，Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw hospital, College of Medicine，Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huzhou Central Hospital</name>
      <address>
        <city>Huzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital,Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>October 24, 2020</last_update_submitted>
  <last_update_submitted_qc>October 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
    <investigator_full_name>yanfugui</investigator_full_name>
    <investigator_title>Vice Director，Respiratory and Critical Care Medicine，Clinical Vice Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Eosinophilia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03237221
org study id: CTVA-China
nct id: NCT03237221
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that
      threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of
      breath, chest tightness and cough, usually occurring at night or early morning. However,
      there are still some patients with only persistent clinical manifestations of chest
      tightness. Concerned about this group of patients, we presented a subgroup of bronchial
      asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks
      asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and
      therefore often misdiagnosed for a long time. In order to further understand the clinical
      characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national
      multicenter observation study to further understand CTVA. Finally, we plan to clarify whether
      CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and
      perform an appropriate treatment of CTVA.
observational model: Case-Only
time perspective: Prospective
measure: Asthma control questionnaire (ACQ)
time frame: Change from Baseline ACQ score at 36 months
description: Asthma control questionnaire (ACQ)
measure: Forced expiratory volume in one second
time frame: Change from Baseline ACQ score at 36 months
description: Forced expiratory volume in one second
measure: Airway responsiveness
time frame: Change from Baseline ACQ score at 36 months
description: Airway responsiveness
measure: Peak expiratory flow
time frame: Change from Baseline ACQ score at 36 months
description: Peak expiratory flow
measure: Asthma quality of life questionnaire
time frame: Change from Baseline ACQ score at 36 months
description: Asthma quality of life questionnaire
measure: Acute asthma episode
time frame: Change from Baseline ACQ score at 36 months
description: Acute asthma episode
measure: Numbers of emergency or hospitalization
time frame: Change from Baseline ACQ score at 36 months
description: Numbers of emergency or hospitalization
intervention type: Drug
intervention name: Treat patient according to Global Initiative for Asthma (GINA) guideline
description: Treat patient according to Global Initiative for Asthma (GINA) guideline
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 80 Years
healthy volunteers: No
last name: Huahao Shen
role: Study Chair
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
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country: China
responsible party type: Principal Investigator
investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
investigator full name: yanfugui
investigator title: Vice Director，Respiratory and Critical Care Medicine，Clinical Vice Professor
mesh term: Asthma
mesh term: Eosinophilia
sharing ipd: Undecided