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/NCT05985694</url>
    </required_header>
    <id_info>
      <org_study_id>ADV_Asthma_17002-1</org_study_id>
      <nct_id>NCT05985694</nct_id>
    </id_info>
    <brief_title>AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma</brief_title>
    <official_title>A Single-blind (Patient-blind), Randomized, Placebo-controlled, Intranasal Administration Study on Mechanisms and Potential Efficacy of AD17002 in Subjects With Poorly Controlled, Moderate to Severe Eosinophilic Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Advagene Biopharma Co. Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Taipei Medical University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Advagene Biopharma Co. Ltd.</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this clinical trial is to investigate patients who have poorly controlled,&#xD;
        moderate to severe eosinophilic asthma. The main questions it aims to answer are Could the&#xD;
        LTh(αK) intranasal treatment improve the clinical condition of these patients? Could patients&#xD;
        self-administrate LTh(αK) via the intranasal route? Is the LTh(αK) at multiple doses safe for&#xD;
        asthmatic patients? Participants will be asked to self-administrate two doses per week for a&#xD;
        total of 6 weeks and a diary on the usage of LTh(αK), adverse event, and reliever medication&#xD;
        used will be recorded.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Eosinophilic asthma is recognized as a sub-phenotype of asthma based on the pattern of&#xD;
        inflammatory cellular infiltration in the airway. Eosinophilic asthma can be associated with&#xD;
        increased asthma severity, atopy, late-onset disease, and steroid refractoriness. Induced&#xD;
        sputum cell count is the gold standard for identifying eosinophilic inflammation in asthma&#xD;
        and fractional exhaled nitric oxide and periostin are emerging as potential surrogates.&#xD;
  &#xD;
        The Type I and III interferons (IFNs) can negatively regulate the allergic reaction, and&#xD;
        their production from mucosal epithelium is reported to be lower in patients with asthma. The&#xD;
        investigational intranasal pharmaceutical product named AD17002 contains a detoxified&#xD;
        Escherichia coli heat-labile enterotoxin, LTh(αK). Studies showed that AD17002 enhanced the&#xD;
        production of Type I and III IFNs from mucosal epithelial cells. Studies also supported that&#xD;
        AD17002 attenuates allergic reactions. The safety and tolerability of LTh(αK) have been&#xD;
        demonstrated in several clinical trials as an intranasal adjuvant for influenza vaccine&#xD;
        (NCT03293732 and NCT03784885) or an intranasal immunomodulator for respiratory&#xD;
        hypersensitivity (NCT04088721) or viral infection (NCT05069610 and NCT05541510).&#xD;
  &#xD;
        This study is conducted to determine the potential efficacy and mechanism of LTh(αK) as a&#xD;
        controller in attenuating the severity of clinical manifestations in patients with unstable,&#xD;
        moderate to severe eosinophilic asthma. Patients with clinical history and ongoing&#xD;
        eosinophilic asthma will be randomly assigned to either AD17002 (10 μg or 20 μg) or placebo,&#xD;
        per 3-4 days, in a 1:1 ratio, in a single-blinded (patient-blinded) fashion. The nasal&#xD;
        administration will be self-administrated by participants. Progression and improvement in&#xD;
        asthmatic symptoms will be recorded. All study subjects will sign ethics committee-approved&#xD;
        informed consent forms before participating in any trial-related activities. Subjects who&#xD;
        participate in this trial of AD17002 will provide information about the dosing, efficacy, and&#xD;
        safety of the new indication that will guide its future clinical use.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">May 3, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 8, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>FEV1 improvement</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>Lung function tests with spirometry</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change to the use of Short-Acting Beta Agonists (SABA)</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>The number of use of rescue Short-Acting Beta Agonists</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fractional exhaled nitric oxide (FeNO) change</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>Change to the FeNO levels</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sputum eosinophil change</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>Change to the induced sputum eosinophils' count</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Asthma Control Test (ACT) scores improvement</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>Change to the ACT scores. A maximum score of 25 points indicates complete asthma control. A score between 20 and 25 represents well controlled asthma, while a score of 19 or below represents not well controlled asthma, and a score less than 16 indicates very poorly controlled asthma.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Corticosteroid used to control asthma</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>Numbers of corticosteroid used, inhaled or oral</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunological biomarkers of sputum</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>Changes in the concentration of sputum IL-4, -5, -13, IFN-α, eosinophil peroxidase (EPO), eosinophil cationic protein (ECP) from the baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunological biomarkers of serum</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>Change of concentration from baseline of induced serum IL-4, -5, -13</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peripheral eosinophil count</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>Change of cell numbers from baseline of peripheral eosinophil count</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events_clinical visit</measure>
      <time_frame>Day 1 to Day 36 and Day 78</time_frame>
      <description>Clinical visit and check up by physicians</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events-Diary</measure>
      <time_frame>Day 1 to Day 78</time_frame>
      <description>Patient self report adverse events via diary</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Eosinophilic Asthma</condition>
    <arm_group>
      <arm_group_label>Cohort 1 Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Formulation buffer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 1 Low dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Formulation buffer + 10 μg LTh(αK)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2 Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Formulation buffer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2 High dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Formulation buffer + 20 μg LTh(αK)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AD17002</intervention_name>
      <description>The investigational intranasal pharmaceutical product named AD17002 contains a detoxified Escherichia coli heat-labile enterotoxin, LTh(αK).&#xD;
  Dosing days: 1, 4, 8, 11, 15, 18, 22, 25, 29, 32.</description>
      <arm_group_label>Cohort 1 Low dose</arm_group_label>
      <arm_group_label>Cohort 2 High dose</arm_group_label>
      <other_name>LTh(αK)</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Formulation buffer. Dosing days: 1, 4, 8, 11, 15, 18, 22, 25, 29, 32.</description>
      <arm_group_label>Cohort 1 Placebo</arm_group_label>
      <arm_group_label>Cohort 2 Placebo</arm_group_label>
      <other_name>Formulation buffer</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject 20-80 years of age on the day of signing informed consent&#xD;
  &#xD;
            2. Subject who is not a current smoker with poorly controlled, moderate to severe&#xD;
               eosinophilic asthma based on GINA 2022 criteria.&#xD;
  &#xD;
            3. Subject who is diagnosed with asthma, over 2 years of follow-up.&#xD;
  &#xD;
            4. Subjects who have the post-bronchodilator reversibility of Forced expiratory volume 1&#xD;
               (FEV1) of ≥ 12% and ≥ 200 mL in response to a SABA at the screening visit or&#xD;
               documented in the medical chart within 2 years of the screening visit.&#xD;
  &#xD;
            5. Subjects who have &gt;15% eosinophil counts in the induced sputum within 7 days of Visit&#xD;
               1.&#xD;
  &#xD;
            6. Subjects with ACT scores &lt;19 under regular low to moderate-dose inhaled&#xD;
               corticosteroids (ICS) and/or a combination with inhaled long-acting beta 2 agonists&#xD;
               for at least 3 months before the Screening Visit.&#xD;
  &#xD;
            7. Subjects without a recent respiratory tract infection within 3 weeks prior to the&#xD;
               study.&#xD;
  &#xD;
            8. Subjects without a recent COVID-19 infection within 3 months prior to study.&#xD;
  &#xD;
            9. Have a negative serum pregnancy test at the screening, and randomization visits&#xD;
               (female subjects of childbearing potential). A female subject who is of reproductive&#xD;
               potential agrees to remain abstinent or use (or have their partner use) an acceptable&#xD;
               method of birth control within the projected duration of the trial. Acceptable birth&#xD;
               control methods are intrauterine devices, hormonal contraception, diaphragm with&#xD;
               spermicide, contraceptive sponge, condoms, and vasectomy, as per local regulations or&#xD;
               guidelines.&#xD;
  &#xD;
           10. A female subject who is not of reproductive potential is eligible without requiring&#xD;
               the use of contraception. A female subject who is not of reproductive potential is&#xD;
               defined as one who has either&#xD;
  &#xD;
                 1. Reached natural menopause (defined as 6 months of spontaneous amenorrhea with&#xD;
                    serum follicle-stimulating hormone levels in the postmenopausal range as&#xD;
                    determined by the laboratory, or 12 months of spontaneous amenorrhea),&#xD;
  &#xD;
                 2. Six weeks postsurgical documented total hysterectomy and/or bilateral&#xD;
                    salpingo-oophorectomy, or&#xD;
  &#xD;
                 3. Bilateral tubal ligation.&#xD;
  &#xD;
           11. Subject or the subject's legal representative understands the trial procedures,&#xD;
               alternative treatments available, and risks involved with the trial, and voluntarily&#xD;
               agrees to participate by giving written informed consent.&#xD;
  &#xD;
           12. Be able to understand, and complete questionnaires and diaries.&#xD;
  &#xD;
           13. Provide written informed consent for the trial and be willing to adhere to dose and&#xD;
               visit schedules.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with serious underlying chronic illness or severe systemic disease, including&#xD;
               SLE, malignant diseases, uremia and heart failure, or abnormal liver function.&#xD;
  &#xD;
            2. Subjects with clinically important lung disease, including but not limited to COPD&#xD;
               (Chronic Obstructive Pulmonary Disease), chronic respiratory infection, lung cancer,&#xD;
               etc.&#xD;
  &#xD;
            3. Arrhythmia, myocardial infarction, or stroke in the last 3 months.&#xD;
  &#xD;
            4. Active COVID-19 disease (SARS-CoV-2 Lateral flow tests (LFA)-positive) at Screening.&#xD;
  &#xD;
            5. A clinical history of persistent allergic asthma or rhinitis caused by an allergen to&#xD;
               which the subject is regularly exposed and sensitized.&#xD;
  &#xD;
            6. A clinical history of active chronic sinusitis (&gt; 3 months).&#xD;
  &#xD;
            7. Any clinically relevant chronic disease (&gt;=3 months duration) (e.g. cystic fibrosis,&#xD;
               malignancy, renal or hepatic insufficiency).&#xD;
  &#xD;
            8. Subject with a documented history of Bell's palsy.&#xD;
  &#xD;
            9. Has any nasal condition that could confound the efficacy or safety assessments (e.g.,&#xD;
               severe nasal polyposis)&#xD;
  &#xD;
           10. Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the&#xD;
               screening visit (except the specified concomitant medications for allergy and asthma&#xD;
               symptoms).&#xD;
  &#xD;
           11. Has unstable or severe asthma, as judged by the clinical Investigator, or a subject&#xD;
               who has experienced a life-threatening asthma attack or an occurrence of any clinical&#xD;
               deterioration of asthma that resulted in emergency treatment, hospitalization due to&#xD;
               asthma, or treatment with systemic corticosteroids (but allowing SABA) at any time&#xD;
               within the last 3 months before Screening Visit.&#xD;
  &#xD;
           12. Has asthma requiring high-dose oral corticosteroid (OCS) within the last 6 months&#xD;
               before Screening Visit.&#xD;
  &#xD;
           13. Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy,&#xD;
               unknown cause, or inhalant allergen.&#xD;
  &#xD;
           14. Has a history of chronic urticaria and/or angioedema within the last 2 years before&#xD;
               the Screening visit.&#xD;
  &#xD;
           15. Is pregnant or expecting to conceive within the projected duration of the trial.&#xD;
  &#xD;
           16. Is nursing at randomization and within the projected duration of the trial?&#xD;
  &#xD;
           17. Has had previous exposure to the study drug or Flu Vaccine AD07030.&#xD;
  &#xD;
           18. Is receiving ongoing treatment with any specific immunotherapy at the time of the&#xD;
               Screening Visit.&#xD;
  &#xD;
           19. Has a known history of allergy, hypersensitivity, or intolerance to investigational&#xD;
               medicinal products, rescue medications, or self-injectable epinephrine&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yushen Hsu, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Advagene Biopharma</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Han-Pin Kuo, MD. Ph.D.</last_name>
      <role>Study Director</role>
      <affiliation>Taipei Medical University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mingi Chang, Ph.D.</last_name>
      <phone>+886-2-7970073</phone>
      <phone_ext>21</phone_ext>
      <email>mingi.chang@advagene.com.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Taipei Medical University Hospital</name>
        <address>
          <city>Taipei</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <contact>
        <last_name>Emily Lien</last_name>
        <phone>+-886-27970073</phone>
        <email>emily.lien@advagene.com.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
      <mesh_term>Pulmonary Eosinophilia</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/NCT05985694
  org study id: ADV_Asthma_17002-1
  nct id: NCT05985694
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate patients who have poorly controlled,
        moderate to severe eosinophilic asthma. The main questions it aims to answer are Could the
        LTh(αK) intranasal treatment improve the clinical condition of these patients? Could patients
        self-administrate LTh(αK) via the intranasal route? Is the LTh(αK) at multiple doses safe for
        asthmatic patients? Participants will be asked to self-administrate two doses per week for a
        total of 6 weeks and a diary on the usage of LTh(αK), adverse event, and reliever medication
        used will be recorded.
  Eosinophilic asthma is recognized as a sub-phenotype of asthma based on the pattern of
        inflammatory cellular infiltration in the airway. Eosinophilic asthma can be associated with
        increased asthma severity, atopy, late-onset disease, and steroid refractoriness. Induced
        sputum cell count is the gold standard for identifying eosinophilic inflammation in asthma
        and fractional exhaled nitric oxide and periostin are emerging as potential surrogates.
  
        The Type I and III interferons (IFNs) can negatively regulate the allergic reaction, and
        their production from mucosal epithelium is reported to be lower in patients with asthma. The
        investigational intranasal pharmaceutical product named AD17002 contains a detoxified
        Escherichia coli heat-labile enterotoxin, LTh(αK). Studies showed that AD17002 enhanced the
        production of Type I and III IFNs from mucosal epithelial cells. Studies also supported that
        AD17002 attenuates allergic reactions. The safety and tolerability of LTh(αK) have been
        demonstrated in several clinical trials as an intranasal adjuvant for influenza vaccine
        (NCT03293732 and NCT03784885) or an intranasal immunomodulator for respiratory
        hypersensitivity (NCT04088721) or viral infection (NCT05069610 and NCT05541510).
  
        This study is conducted to determine the potential efficacy and mechanism of LTh(αK) as a
        controller in attenuating the severity of clinical manifestations in patients with unstable,
        moderate to severe eosinophilic asthma. Patients with clinical history and ongoing
        eosinophilic asthma will be randomly assigned to either AD17002 (10 μg or 20 μg) or placebo,
        per 3-4 days, in a 1:1 ratio, in a single-blinded (patient-blinded) fashion. The nasal
        administration will be self-administrated by participants. Progression and improvement in
        asthmatic symptoms will be recorded. All study subjects will sign ethics committee-approved
        informed consent forms before participating in any trial-related activities. Subjects who
        participate in this trial of AD17002 will provide information about the dosing, efficacy, and
        safety of the new indication that will guide its future clinical use.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: FEV1 improvement
  time frame: Day 1 to Day 78
  description: Lung function tests with spirometry
  measure: Change to the use of Short-Acting Beta Agonists (SABA)
  time frame: Day 1 to Day 78
  description: The number of use of rescue Short-Acting Beta Agonists
  measure: Fractional exhaled nitric oxide (FeNO) change
  time frame: Day 1 to Day 78
  description: Change to the FeNO levels
  measure: Sputum eosinophil change
  time frame: Day 1 to Day 78
  description: Change to the induced sputum eosinophils' count
  measure: Asthma Control Test (ACT) scores improvement
  time frame: Day 1 to Day 78
  description: Change to the ACT scores. A maximum score of 25 points indicates complete asthma control. A score between 20 and 25 represents well controlled asthma, while a score of 19 or below represents not well controlled asthma, and a score less than 16 indicates very poorly controlled asthma.
  measure: Corticosteroid used to control asthma
  time frame: Day 1 to Day 78
  description: Numbers of corticosteroid used, inhaled or oral
  measure: Immunological biomarkers of sputum
  time frame: Day 1 to Day 78
  description: Changes in the concentration of sputum IL-4, -5, -13, IFN-α, eosinophil peroxidase (EPO), eosinophil cationic protein (ECP) from the baseline
  measure: Immunological biomarkers of serum
  time frame: Day 1 to Day 78
  description: Change of concentration from baseline of induced serum IL-4, -5, -13
  measure: Peripheral eosinophil count
  time frame: Day 1 to Day 78
  description: Change of cell numbers from baseline of peripheral eosinophil count
  measure: Adverse events_clinical visit
  time frame: Day 1 to Day 36 and Day 78
  description: Clinical visit and check up by physicians
  measure: Adverse events-Diary
  time frame: Day 1 to Day 78
  description: Patient self report adverse events via diary
  arm group label: Cohort 1 Placebo
  arm group type: Placebo Comparator
  description: Formulation buffer
  arm group label: Cohort 1 Low dose
  arm group type: Experimental
  description: Formulation buffer + 10 μg LTh(αK)
  arm group label: Cohort 2 Placebo
  arm group type: Placebo Comparator
  description: Formulation buffer
  arm group label: Cohort 2 High dose
  arm group type: Experimental
  description: Formulation buffer + 20 μg LTh(αK)
  intervention type: Drug
  intervention name: AD17002
  description: The investigational intranasal pharmaceutical product named AD17002 contains a detoxified Escherichia coli heat-labile enterotoxin, LTh(αK).
  Dosing days: 1, 4, 8, 11, 15, 18, 22, 25, 29, 32.
  arm group label: Cohort 1 Low dose
  arm group label: Cohort 2 High dose
  other name: LTh(αK)
  intervention type: Drug
  intervention name: Placebo
  description: Formulation buffer. Dosing days: 1, 4, 8, 11, 15, 18, 22, 25, 29, 32.
  arm group label: Cohort 1 Placebo
  arm group label: Cohort 2 Placebo
  other name: Formulation buffer
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Yushen Hsu, Ph.D.
  role: Study Chair
  affiliation: Advagene Biopharma
  last name: Han-Pin Kuo, MD. Ph.D.
  role: Study Director
  affiliation: Taipei Medical University Hospital
  last name: Mingi Chang, Ph.D.
  phone: +886-2-7970073
  phone ext: 21
  email: mingi.chang@advagene.com.tw
  facility: 
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Asthma
  mesh term: Pulmonary Eosinophilia