<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/NCT03258749</url>
  </required_header>
  <id_info>
    <org_study_id>KY2017-009</org_study_id>
    <nct_id>NCT03258749</nct_id>
  </id_info>
  <brief_title>Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD</brief_title>
  <acronym>FACT</acronym>
  <official_title>Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD: a Randomised, Open-label, Multicentre Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huashan Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is a disease state characterized by persistent&#xD;
      airflow limitation and associated with an accelerated decline in lung function, impaired&#xD;
      quality of life, hospitalization, and increased mortality. As a major public health problem,&#xD;
      COPD is predicted to rank as the fifth burden of diseases in the world by 2020. Thus,&#xD;
      prevention of exacerbations is a important goal in the management of COPD. The Global&#xD;
      Initiative for Chronic Obstructive Lung Disease (GOLD) Scientific Committee launched a joint&#xD;
      project in 1998. Its goals were to raise awareness of COPD and to improve prevention and&#xD;
      treatment of COPD patients around the world. In the 2017 GOLD guidelines, inhaled long-acting&#xD;
      bronchodilators, including inhaled long-acting muscarinic antagonists (LAMAs) and inhaled&#xD;
      long-acting beta-agonists (LABAs), are recommended for the management of all stable COPD&#xD;
      patients. However, it is not known whether LABA or LAMA will be more effective for initial&#xD;
      relief of symptoms in patients with GOLD A/B COPD. In this multicenter, randomized study, the&#xD;
      investigators evaluate the efficacy of formoterol(LABA) and tiotropium(LAMA) in the treatment&#xD;
      of patients with GOLD A/B COPD. The primary endpoint is postbronchodilator FEV1, and the&#xD;
      secondary endpoints include the frequency of COPD exacerbation, other lung function&#xD;
      parameters, CCQ score and mMRC/CAT score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postbronchodilator FEV1</measure>
    <time_frame>12 months</time_frame>
    <description>a post-bronchodilator forced expiratory volume in one second</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the frequency of COPD exacerbation</measure>
    <time_frame>12 months</time_frame>
    <description>the frequency of COPD exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>other lung function parameters</measure>
    <time_frame>12 months</time_frame>
    <description>other lung function parameters(%FEV1, FEV1/FVC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CCQ score</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical COPD Questionnaire score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mMRC score</measure>
    <time_frame>12 months</time_frame>
    <description>modified Medical Research Council score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CAT score</measure>
    <time_frame>12 months</time_frame>
    <description>COPD Assessment Test score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Formoterol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>inhaled formoterol(4.5μg, bid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tiotropium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>inhaled Tiotropium(18μg, qd)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tiotropium</intervention_name>
    <description>inhaled Tiotropium(18μg, qd)</description>
    <arm_group_label>Tiotropium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formoterol</intervention_name>
    <description>inhaled formoterol(4.5μg, bid)</description>
    <arm_group_label>Formoterol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of group A or group B stable COPD. Must be able to inhale Formoterol or&#xD;
        Tiotropium.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Asthma. Cystic fibrosis. Bronchiectasis. Lung cancer. Glaucoma. Tachyarrhythmia or other&#xD;
        serious heart diseases. Prostatic hyperplasia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shengqing Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huashan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shengqing Li, PhD</last_name>
    <phone>+8602152887072</phone>
    <email>shengqingli@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Peng Zhang, MD</last_name>
    <phone>+8602152887073</phone>
    <email>chang0311@foxmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Huashan hospital,Fudan university</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Shengqing Li, PhD</last_name>
      <phone>+8602152887072</phone>
      <email>shengqingli@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Peng Zhang, MD</last_name>
      <phone>+8602152887073</phone>
      <email>chang0311@foxmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huashan Hospital</investigator_affiliation>
    <investigator_full_name>Shengqing Li</investigator_full_name>
    <investigator_title>Chief Physician,Professor</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>GOLD</keyword>
  <keyword>formoterol</keyword>
  <keyword>tiotropium</keyword>
  <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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Formoterol Fumarate</mesh_term>
    <mesh_term>Tiotropium Bromide</mesh_term>
  </intervention_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/NCT03258749
org study id: KY2017-009
nct id: NCT03258749
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Chronic obstructive pulmonary disease (COPD) is a disease state characterized by persistent
      airflow limitation and associated with an accelerated decline in lung function, impaired
      quality of life, hospitalization, and increased mortality. As a major public health problem,
      COPD is predicted to rank as the fifth burden of diseases in the world by 2020. Thus,
      prevention of exacerbations is a important goal in the management of COPD. The Global
      Initiative for Chronic Obstructive Lung Disease (GOLD) Scientific Committee launched a joint
      project in 1998. Its goals were to raise awareness of COPD and to improve prevention and
      treatment of COPD patients around the world. In the 2017 GOLD guidelines, inhaled long-acting
      bronchodilators, including inhaled long-acting muscarinic antagonists (LAMAs) and inhaled
      long-acting beta-agonists (LABAs), are recommended for the management of all stable COPD
      patients. However, it is not known whether LABA or LAMA will be more effective for initial
      relief of symptoms in patients with GOLD A/B COPD. In this multicenter, randomized study, the
      investigators evaluate the efficacy of formoterol(LABA) and tiotropium(LAMA) in the treatment
      of patients with GOLD A/B COPD. The primary endpoint is postbronchodilator FEV1, and the
      secondary endpoints include the frequency of COPD exacerbation, other lung function
      parameters, CCQ score and mMRC/CAT score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: postbronchodilator FEV1
time frame: 12 months
description: a post-bronchodilator forced expiratory volume in one second
measure: the frequency of COPD exacerbation
time frame: 12 months
description: the frequency of COPD exacerbation
measure: other lung function parameters
time frame: 12 months
description: other lung function parameters(%FEV1, FEV1/FVC)
measure: CCQ score
time frame: 12 months
description: Clinical COPD Questionnaire score
measure: mMRC score
time frame: 12 months
description: modified Medical Research Council score
measure: CAT score
time frame: 12 months
description: COPD Assessment Test score
arm group label: Formoterol
arm group type: Active Comparator
description: inhaled formoterol(4.5μg, bid)
arm group label: Tiotropium
arm group type: Experimental
description: inhaled Tiotropium(18μg, qd)
intervention type: Drug
intervention name: Tiotropium
description: inhaled Tiotropium(18μg, qd)
arm group label: Tiotropium
intervention type: Drug
intervention name: Formoterol
description: inhaled formoterol(4.5μg, bid)
arm group label: Formoterol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shengqing Li, PhD
role: Principal Investigator
affiliation: Huashan Hospital
last name: Shengqing Li, PhD
phone: +8602152887072
email: shengqingli@hotmail.com
last name: Peng Zhang, MD
phone: +8602152887073
email: chang0311@foxmail.com
facility: 
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Shengqing Li
investigator title: Chief Physician,Professor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Formoterol Fumarate
mesh term: Tiotropium Bromide