<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/NCT04456205</url>
  </required_header>
  <id_info>
    <org_study_id>201908041RIND</org_study_id>
    <nct_id>NCT04456205</nct_id>
  </id_info>
  <brief_title>Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <official_title>The Clinical Effect of Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University 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>
      According to the WISDOM study, withdraw of inhaled steroids has no effect on the acute&#xD;
      exacerbation of chronic obstructive pulmonary disease (COPD), but the lung function of&#xD;
      patients with COPD is significantly reclined. In the subgroup analysis of this study,&#xD;
      patients with COPD were found to have continued to use inhaled steroids in patients with&#xD;
      eosinophilic leukocytes greater than 400 cells/ul or whom has more than two episodes of&#xD;
      exacerbation per year. However, in SUNSET study, it was pointed out that withdraw of inhaled&#xD;
      steroids had no effect on lung function in patients with COPD, but it was also found that in&#xD;
      patients with COPD, eosinophilic leukocytes in the blood were greater than 300 cells/ul, have&#xD;
      a better therapeutic response in steroid inhalation. In addition, some studies have shown&#xD;
      that in patients with COPD, a decline in lung function after discontinuation of inhaled&#xD;
      steroids can make the patient's clinical symptoms worse and increase the risk of acute&#xD;
      exacerbations. However, in other comprehensive analytical studies, there are different&#xD;
      outcomes. There is no statistically significant difference in the risk of acute exacerbation&#xD;
      in patients with COPD after discontinuation of inhaled steroids.&#xD;
&#xD;
      In past studies, it was noted that inhaled steroids cause an increased risk of pneumonia in&#xD;
      patients with COPD. However, in these studies, the diagnosis of pneumonia was only from the&#xD;
      clinician's suspicion without clear symptom assessment, laboratory examination,&#xD;
      microbiological evidence or imaging assessment. Therefore, further research is needed to&#xD;
      assess whether patients are suitable for the reduction of inhaled steroids and the impact of&#xD;
      COPD in clinical treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary Function Test (FEV1)</measure>
    <time_frame>6 months</time_frame>
    <description>Spirometry test with forced expiratory volume in one second (FEV1)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulmonary Function Test (FVC)</measure>
    <time_frame>6 months</time_frame>
    <description>Spirometry test with forced vital capacity (FVC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulmonary Function Test (FEV1/FVC)</measure>
    <time_frame>6 months</time_frame>
    <description>Spirometry test with FEV1/FVC ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Acute Exacerbation</measure>
    <time_frame>6 months</time_frame>
    <description>Sudden worsening of COPD symptoms with out-patient clinic and emergency department visit or hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COPD Assessment Test (CAT) score</measure>
    <time_frame>6 months</time_frame>
    <description>COPD Assessment Test (CAT) score ( a patient-completed questionnaire assessing all aspects of the impact of COPD, including cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels) provides a score of 0-40 to indicate the impact of COPD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Medical Research Council (mMRC) Dyspnea Scale</measure>
    <time_frame>6 months</time_frame>
    <description>Modified Medical Research Council (mMRC) Dyspnea Scale is consisting of just five items containing statements about the impact of breathlessness on the individual and leading to a grade from 1 to 5. (1. Not troubled by breathless except on strenuous exercise; 2. Short of breath when hurrying on a level or when walking up a slight hill; 3. Walks slower than most people on the level, stops after a mile or so, or stops after 15 min walking at own pace; 4. Stops for breath after walking 100 yards, or after a few minutes on level ground; 5. Too breathless to leave the house, or breathless when dressing/undressing).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>COPD</condition>
  <condition>Inhaled Corticosteroid</condition>
  <arm_group>
    <arm_group_label>Dual Therapy</arm_group_label>
    <description>Dual Therapy (long-acting muscarinic antagonist [LAMA] + long-acting beta-agonist [LABA])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triple Therapy</arm_group_label>
    <description>Triple Therapy (inhaled corticosteroid [ICS]/ long-acting beta-agonist [LABA] + long-acting muscarinic antagonist [LAMA])</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Conformed COPD patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed patients with COPD (at least one lung function test post bronchodilator&#xD;
             FEV1/FVC &lt;70% before the start of the study)&#xD;
&#xD;
          -  Age ≥ 40 years old&#xD;
&#xD;
          -  No acute attack record within half a year&#xD;
&#xD;
          -  Triple therapy (dual long-acting inhaled bronchodilator and inhaled steroid) is stable&#xD;
             for more than six months.&#xD;
&#xD;
          -  Eosinophil count in blood &lt;300 cells/ul&#xD;
&#xD;
          -  Clinical symptom assessment CAT score &lt;20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected or diagnosed with asthma&#xD;
&#xD;
          -  Age &lt;40 years&#xD;
&#xD;
          -  Within half a year, there is a record of moderate to severe acute attacks&#xD;
&#xD;
          -  Eosinophil count in blood ≥300 cells/ul&#xD;
&#xD;
          -  Clinical symptom assessment CAT score ≥20&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chung-Yu Chen</name>
      <address>
        <city>Douliu</city>
        <state>Yunlin</state>
        <zip>640</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chung-Yu Chen</last_name>
      <phone>88655323911</phone>
      <phone_ext>5853</phone_ext>
      <email>c8101147@ms16.hinet.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</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>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Respiratory Aspiration</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/NCT04456205
org study id: 201908041RIND
nct id: NCT04456205
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
According to the WISDOM study, withdraw of inhaled steroids has no effect on the acute
      exacerbation of chronic obstructive pulmonary disease (COPD), but the lung function of
      patients with COPD is significantly reclined. In the subgroup analysis of this study,
      patients with COPD were found to have continued to use inhaled steroids in patients with
      eosinophilic leukocytes greater than 400 cells/ul or whom has more than two episodes of
      exacerbation per year. However, in SUNSET study, it was pointed out that withdraw of inhaled
      steroids had no effect on lung function in patients with COPD, but it was also found that in
      patients with COPD, eosinophilic leukocytes in the blood were greater than 300 cells/ul, have
      a better therapeutic response in steroid inhalation. In addition, some studies have shown
      that in patients with COPD, a decline in lung function after discontinuation of inhaled
      steroids can make the patient's clinical symptoms worse and increase the risk of acute
      exacerbations. However, in other comprehensive analytical studies, there are different
      outcomes. There is no statistically significant difference in the risk of acute exacerbation
      in patients with COPD after discontinuation of inhaled steroids.

      In past studies, it was noted that inhaled steroids cause an increased risk of pneumonia in
      patients with COPD. However, in these studies, the diagnosis of pneumonia was only from the
      clinician's suspicion without clear symptom assessment, laboratory examination,
      microbiological evidence or imaging assessment. Therefore, further research is needed to
      assess whether patients are suitable for the reduction of inhaled steroids and the impact of
      COPD in clinical treatment.
observational model: Case-Control
time perspective: Prospective
measure: Pulmonary Function Test (FEV1)
time frame: 6 months
description: Spirometry test with forced expiratory volume in one second (FEV1)
measure: Pulmonary Function Test (FVC)
time frame: 6 months
description: Spirometry test with forced vital capacity (FVC)
measure: Pulmonary Function Test (FEV1/FVC)
time frame: 6 months
description: Spirometry test with FEV1/FVC ratio
measure: Frequency of Acute Exacerbation
time frame: 6 months
description: Sudden worsening of COPD symptoms with out-patient clinic and emergency department visit or hospitalization
measure: COPD Assessment Test (CAT) score
time frame: 6 months
description: COPD Assessment Test (CAT) score ( a patient-completed questionnaire assessing all aspects of the impact of COPD, including cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels) provides a score of 0-40 to indicate the impact of COPD.
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
time frame: 6 months
description: Modified Medical Research Council (mMRC) Dyspnea Scale is consisting of just five items containing statements about the impact of breathlessness on the individual and leading to a grade from 1 to 5. (1. Not troubled by breathless except on strenuous exercise; 2. Short of breath when hurrying on a level or when walking up a slight hill; 3. Walks slower than most people on the level, stops after a mile or so, or stops after 15 min walking at own pace; 4. Stops for breath after walking 100 yards, or after a few minutes on level ground; 5. Too breathless to leave the house, or breathless when dressing/undressing).
arm group label: Dual Therapy
description: Dual Therapy (long-acting muscarinic antagonist [LAMA] + long-acting beta-agonist [LABA])
arm group label: Triple Therapy
description: Triple Therapy (inhaled corticosteroid [ICS]/ long-acting beta-agonist [LABA] + long-acting muscarinic antagonist [LAMA])
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Respiratory Aspiration