<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/NCT04454385</url>
  </required_header>
  <id_info>
    <org_study_id>56/2563</org_study_id>
    <nct_id>NCT04454385</nct_id>
  </id_info>
  <brief_title>The Correlations of FeNO, Blood Eosinophils and Lung Function in Well-controlled Asthma</brief_title>
  <official_title>The Correlations of FeNO, Blood Eosinophils and Lung Function in Well-controlled Asthma Based on Asthma Controlled Questionnaires</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hat Yai Medical Education Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hat Yai Medical Education Center</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>
      In Asthma, the levels of exhaled FeNO is correlated to sputum eosinophils particularly in the&#xD;
      patient with poor controlled asthma or severe asthma. Moreover, the blood eosinophils had&#xD;
      been studied that are also correlated to sputum eosinophils in similar patients group.&#xD;
      According to well controlled asthma, althoug hin clinical practice guidelines recommend that&#xD;
      the stepping down therapy should be considered to those patients due to the risks or costs of&#xD;
      daily treatment, there is previous study has been shown that the airway hyperresponsiveness&#xD;
      and sputum eosinophilia are predictors of loss of control during dose reduction. And, these&#xD;
      tests are not readily available in primary care. However, there is limit number of clinical&#xD;
      study to study the correlation of biologic markers among the patients with well controlled&#xD;
      level before the stepping down management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single prospective trial. Enrollment will continue until 50 patients with well&#xD;
      controlled asthma have been entered into this trial and have completed blood tests and&#xD;
      spirometry. In this trial, the following parameters are to be evaluated:&#xD;
&#xD;
      Blood eosinophils (absolute and relative) FeNO Pulmonary lung function test: FEV1, FVC, PF,&#xD;
      MMEF 25-75%, % reversibility&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 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>Assessment of eosinophilic inflammation by correlating blood eosinophil count, FeNO measurement and lung function test</measure>
    <time_frame>3 months</time_frame>
    <description>Correlation of FeNO, blood eosinophils, lung function test in patients with well controlled asthma before stepping down medication</description>
  </primary_outcome>
  <enrollment type="Actual">84</enrollment>
  <condition>Asthma</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Patients with well controlled asthma</intervention_name>
    <description>Patients with well controlled asthma&#xD;
The following parameters are to be evaluated:&#xD;
Blood eosinophils FeNO Findings on lung function test</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood for CBC analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with well controlled asthma treating with step 3 base on GINA by only low dose&#xD;
        ICS/LABA based on ACT (&gt; = 23) and ACQ-7 (&lt;0.75) for at least 12 weeks&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosis of asthma (according to the guidelines)&#xD;
&#xD;
          -  Age &gt;15 years&#xD;
&#xD;
          -  Patients with treating with step 3 base on GINA by only low dose ICS/LABA without oral&#xD;
             bronchodilator with being in well controlled asthma based on ACT (&gt; = 23) and ACQ-7&#xD;
             (&lt;0.75) for at least 12 weeks&#xD;
&#xD;
          -  Ability to provide informed consent and do spirometry following ATS guideline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pulmonary infection or exacerbation within the last 12 weeks before enrolment&#xD;
&#xD;
          -  Patients with preceding taken systemic steroid 12 week before enrolment&#xD;
&#xD;
          -  Additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung&#xD;
             disease)&#xD;
&#xD;
          -  A history of smoking &gt;= 10 pack-year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Narongwit Nakwan</name>
      <address>
        <city>Hat Yai</city>
        <state>Songkhla</state>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>January 14, 2021</last_update_submitted>
  <last_update_submitted_qc>January 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hat Yai Medical Education Center</investigator_affiliation>
    <investigator_full_name>Narongwit Nakwan</investigator_full_name>
    <investigator_title>Asst.prof Narongwit Nakwan</investigator_title>
  </responsible_party>
  <keyword>FeNO</keyword>
  <keyword>Blood eosinophil</keyword>
  <keyword>Pulmonary function test</keyword>
  <keyword>Well controlled asthma</keyword>
  <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>


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/NCT04454385
org study id: 56/2563
nct id: NCT04454385
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Asthma, the levels of exhaled FeNO is correlated to sputum eosinophils particularly in the
      patient with poor controlled asthma or severe asthma. Moreover, the blood eosinophils had
      been studied that are also correlated to sputum eosinophils in similar patients group.
      According to well controlled asthma, althoug hin clinical practice guidelines recommend that
      the stepping down therapy should be considered to those patients due to the risks or costs of
      daily treatment, there is previous study has been shown that the airway hyperresponsiveness
      and sputum eosinophilia are predictors of loss of control during dose reduction. And, these
      tests are not readily available in primary care. However, there is limit number of clinical
      study to study the correlation of biologic markers among the patients with well controlled
      level before the stepping down management.
This is a single prospective trial. Enrollment will continue until 50 patients with well
      controlled asthma have been entered into this trial and have completed blood tests and
      spirometry. In this trial, the following parameters are to be evaluated:

      Blood eosinophils (absolute and relative) FeNO Pulmonary lung function test: FEV1, FVC, PF,
      MMEF 25-75%, % reversibility
observational model: Cohort
time perspective: Prospective
measure: Assessment of eosinophilic inflammation by correlating blood eosinophil count, FeNO measurement and lung function test
time frame: 3 months
description: Correlation of FeNO, blood eosinophils, lung function test in patients with well controlled asthma before stepping down medication
intervention type: Diagnostic Test
intervention name: Patients with well controlled asthma
description: Patients with well controlled asthma
The following parameters are to be evaluated:
Blood eosinophils FeNO Findings on lung function test
Blood for CBC analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Hat Yai Medical Education Center
investigator full name: Narongwit Nakwan
investigator title: Asst.prof Narongwit Nakwan
mesh term: Asthma