xml: <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/NCT06026462</url>
    </required_header>
    <id_info>
      <org_study_id>2022-09-21-03</org_study_id>
      <nct_id>NCT06026462</nct_id>
    </id_info>
    <brief_title>Retrospective Cohort Study on Asthma With Frequent Acute Attacks Phenotype</brief_title>
    <official_title>A Retrospective Cohort Study on the Risk Factors and Prognosis of Asthma With Frequent Acute Attacks Phenotype</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qianfoshan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qianfoshan Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1. Identify the risk factors for frequent acute exacerbations of asthma: establish a&#xD;
             retrospective study, classify patients into frequent acute exacerbation group and&#xD;
             non-frequent acute exacerbation group based on the number of acute exacerbations,&#xD;
             analyze the characteristics of the two groups, provide clinical, pathological, and&#xD;
             comorbidity features of the frequent acute exacerbation subtype of asthma, determine the&#xD;
             risk factors associated with frequent acute exacerbations, and establish a disease&#xD;
             prediction model for frequent acute exacerbations of asthma.&#xD;
  &#xD;
          2. Observe the prognosis and treatment outcome of patients with frequent acute&#xD;
             exacerbations of asthma, clarify the relevant factors for poor prognosis in this group&#xD;
             of patients, and explore individualized treatment plans to improve the prognosis of&#xD;
             patients.&#xD;
  &#xD;
          3. Investigate the inflammatory mechanism of frequent acute exacerbations of asthma: use&#xD;
             omics methods to screen for subtype-specific biomarkers of frequent acute exacerbations&#xD;
             and validate them, clarify the pathogenesis of this subtype, and discover new specific&#xD;
             treatment targets.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Annualized asthma exacerbation rate</measure>
      <time_frame>one year</time_frame>
      <description>Annual asthma exacerbation rate is calculated as total number of exacerbations of interest divided by the total time at risk</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Post-bronchodilator forced expiratory volume in 1 second</measure>
      <time_frame>up to one year</time_frame>
      <description>Lung function will be described.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median inhaled corticosteroids (ICS) dose change</measure>
      <time_frame>one year</time_frame>
      <description>Asthma related ICS use will be described.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">540</enrollment>
    <condition>Asthma</condition>
    <arm_group>
      <arm_group_label>Asthma with frequent acute exacerbations phenotype</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Asthma with Intermittent acute exacerbations phenotype</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Observation of clinical indicators related to asthma</intervention_name>
      <description>Observe the severity of asthma, drug compliance, comorbidities, asthma control, pulmonary function, FeNO, and the number of acute episodes of asthma</description>
      <arm_group_label>Asthma with Intermittent acute exacerbations phenotype</arm_group_label>
      <arm_group_label>Asthma with frequent acute exacerbations phenotype</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Asthma patients who continuously visit our hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          18-65 years old, taking asthma medication for at least 4 weeks. The diagnostic criteria for&#xD;
          asthma are based on the recommendations of the current guidelines (Guidelines for the&#xD;
          Prevention and Treatment of Bronchial Asthma (Version 2020), as follows:&#xD;
  &#xD;
            1. Repeated episodes of wheezing, shortness of breath, chest tightness, or coughing are&#xD;
               often associated with exposure to allergens, cold air, physical and chemical stimuli,&#xD;
               viral upper respiratory tract infections, and exercise.&#xD;
  &#xD;
            2. During the attack, scattered or diffuse wheezing sounds can be heard in both lungs,&#xD;
               mainly in the expiratory phase, and the expiratory phase is prolonged.&#xD;
  &#xD;
            3. The above symptoms and signs can be alleviated by treatment or spontaneously.&#xD;
  &#xD;
            4. Except for wheezing, shortness of breath, chest tightness, and coughing caused by&#xD;
               other diseases.&#xD;
  &#xD;
            5. Those with atypical clinical manifestations (such as no obvious wheezing or physical&#xD;
               signs) should have at least one positive pulmonary function test as follows: 1.&#xD;
               Positive bronchial provocation test or exercise provocation test; The positive FEV1 of&#xD;
               bronchodilator test increased by ≥ 12%;, And the absolute value of FEV1 increase ≥&#xD;
               200ml; 3. Peak expiratory flow (PEF) intraday (or 2-week) variability ≥ 20%.&#xD;
  &#xD;
          Asthma can be diagnosed if it meets the criteria of 1-4 or 4-5.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Complicated with pneumonia, pulmonary interstitial fibrosis, active pulmonary&#xD;
               tuberculosis, obstructive sleep apnea hypopnea syndrome, and other respiratory system&#xD;
               related diseases, with a previous history of lung surgery;&#xD;
  &#xD;
            2. Those with the following diseases or conditions: severe, progressive, or uncontrolled&#xD;
               cardiovascular, liver, kidney, hematopoietic, and neurological disorders; Malignant&#xD;
               tumor; Or the presence of immunosuppression (including the use of immunosuppressants&#xD;
               or HIV infection resulting in low immune function);&#xD;
  &#xD;
            3. Accompanied by severe gastrointestinal diseases (such as inflammatory bowel disease&#xD;
               [IBD] or irritable bowel syndrome [IBS]), severe diarrhea (watery stools more than 3&#xD;
               times and lasting for more than 3 days) and constipation (less than 2 stools per week&#xD;
               and accompanied by difficulty in defecation) in the past 3 weeks;&#xD;
  &#xD;
            4. Systematic application of antibiotics, systemic glucocorticoids (including oral,&#xD;
               intravenous [IV] or intramuscular [IM]), microecological agents, or traditional&#xD;
               Chinese medicine within the past 4 weeks;&#xD;
  &#xD;
            5. Excessive obesity (BMI&gt;32.0 kg/m2), pregnant and lactating women;&#xD;
  &#xD;
            6. Poor compliance, unable to cooperate with clinical observation and specimen&#xD;
               collection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Liang Dong, PHD</last_name>
      <phone>17853138213</phone>
      <email>zjt9607@126.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Qianfoshan Hospital</investigator_affiliation>
      <investigator_full_name>Liang Dong</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <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>
  
  
text: 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/NCT06026462
  org study id: 2022-09-21-03
  nct id: NCT06026462
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  1. Identify the risk factors for frequent acute exacerbations of asthma: establish a
             retrospective study, classify patients into frequent acute exacerbation group and
             non-frequent acute exacerbation group based on the number of acute exacerbations,
             analyze the characteristics of the two groups, provide clinical, pathological, and
             comorbidity features of the frequent acute exacerbation subtype of asthma, determine the
             risk factors associated with frequent acute exacerbations, and establish a disease
             prediction model for frequent acute exacerbations of asthma.
  
          2. Observe the prognosis and treatment outcome of patients with frequent acute
             exacerbations of asthma, clarify the relevant factors for poor prognosis in this group
             of patients, and explore individualized treatment plans to improve the prognosis of
             patients.
  
          3. Investigate the inflammatory mechanism of frequent acute exacerbations of asthma: use
             omics methods to screen for subtype-specific biomarkers of frequent acute exacerbations
             and validate them, clarify the pathogenesis of this subtype, and discover new specific
             treatment targets.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Annualized asthma exacerbation rate
  time frame: one year
  description: Annual asthma exacerbation rate is calculated as total number of exacerbations of interest divided by the total time at risk
  measure: Post-bronchodilator forced expiratory volume in 1 second
  time frame: up to one year
  description: Lung function will be described.
  measure: Median inhaled corticosteroids (ICS) dose change
  time frame: one year
  description: Asthma related ICS use will be described.
  arm group label: Asthma with frequent acute exacerbations phenotype
  arm group label: Asthma with Intermittent acute exacerbations phenotype
  intervention type: Diagnostic Test
  intervention name: Observation of clinical indicators related to asthma
  description: Observe the severity of asthma, drug compliance, comorbidities, asthma control, pulmonary function, FeNO, and the number of acute episodes of asthma
  arm group label: Asthma with Intermittent acute exacerbations phenotype
  arm group label: Asthma with frequent acute exacerbations phenotype
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  last name: Liang Dong, PHD
  phone: 17853138213
  email: zjt9607@126.com
  responsible party type: Principal Investigator
  investigator affiliation: Qianfoshan Hospital
  investigator full name: Liang Dong
  investigator title: Clinical Professor
  mesh term: Asthma