<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/NCT02195375</url>
  </required_header>
  <id_info>
    <org_study_id>FLT3510</org_study_id>
    <nct_id>NCT02195375</nct_id>
  </id_info>
  <brief_title>Flutiform® Compared With Seretide® in the Treatment of COPD</brief_title>
  <official_title>A Randomised Double-blind, Double-dummy Parallel Group Study to Compare the Efficacy and Safety of Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 500/20 µg BID and 250/10 µg BID Versus Salmeterol / Fluticasone (Seretide®) 50/500 µg BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mundipharma Research Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mundipharma Research Limited</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether flutiform® is effective and safe in the&#xD;
      treatment of chronic obstructive pulmonary disease (COPD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group&#xD;
      study in male and female subjects conducted to assess the efficacy and safety of flutiform in&#xD;
      the treatment of COPD. Subjects will be randomised to one of three treatment groups in a&#xD;
      1:1:1 ratio. Throughout the study subjects will be assessed on a mixture of symptom based and&#xD;
      lung function measurements to monitor their progress in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average pre-dose FEV1</measure>
    <time_frame>26 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average 1 hour Post dose FEV1, FVC, FEV6</measure>
    <time_frame>26 Weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Moderate and Severe COPD Exacerbations</measure>
    <time_frame>26 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>COPD Assessment Test</measure>
    <time_frame>Change from baseline to week 8, week 14, week 26</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Average capacity of daily living during the morning score</measure>
    <time_frame>26 weeks</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">923</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Flutiform 500/20 µg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Flutiform 250/10 (2 puffs BID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flutiform 250/10 µg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Flutiform 125/5 (2 puffs BID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Seretide Accuhaler 50/500 µg BID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Seretide Accuhaler 50/500 (BID)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flutiform 500/20 µg BID</intervention_name>
    <arm_group_label>Flutiform 500/20 µg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flutiform 250/10 µg BID</intervention_name>
    <arm_group_label>Flutiform 250/10 µg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Seretide Accuhaler 50/500 µg BID</intervention_name>
    <arm_group_label>Seretide Accuhaler 50/500 µg BID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          1. Male or Female subjects aged ≥ 40 years at screening visit.&#xD;
&#xD;
          2. Diagnosis of COPD&#xD;
&#xD;
          3. Willing and able to replace current COPD therapy with study medication.&#xD;
&#xD;
          4. Able to demonstrate correct use of a pMDI with or without a spacer and Accuhaler.&#xD;
&#xD;
          5. Willing and able to attend all study visits and complete study assessments.&#xD;
&#xD;
          6. Able to provide signed informed consent.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          1. Ongoing moderate or severe exacerbation of COPD in the 2 weeks before screening.&#xD;
&#xD;
          2. Current diagnosis of asthma.&#xD;
&#xD;
          3. Documented evidence of α1-antitrypsin deficiency as the underlying cause of COPD.&#xD;
&#xD;
          4. Other active respiratory disease such as active tuberculosis, lung cancer,&#xD;
             bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung&#xD;
             disease, cystic fibrosis, bronchiolitis obliterans.&#xD;
&#xD;
          5. Previous lung resection.&#xD;
&#xD;
          6. Use of long-term oxygen therapy (LTOT) or mechanical ventilation. Note: LTOT is&#xD;
             defined as &gt;15 hours use per day&#xD;
&#xD;
          7. Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities&#xD;
             not believed to be due to COPD.&#xD;
&#xD;
          8. Evidence of uncontrolled cardiovascular disease.&#xD;
&#xD;
          9. Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric&#xD;
             disease.&#xD;
&#xD;
         10. Current malignancy or a previous history of cancer which has been in remission for &lt; 5&#xD;
             years (basal cell or squamous cell carcinoma of the skin which has been resected is&#xD;
             not excluded).&#xD;
&#xD;
         11. Clinically significant sleep apnoea requiring use of continuous positive airway&#xD;
             pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.&#xD;
&#xD;
         12. Participation in the acute phase of a pulmonary rehabilitation programme within 4&#xD;
             weeks prior to screening or during the study.&#xD;
&#xD;
         13. Known or suspected history of drug or alcohol abuse in the last 2 years.&#xD;
&#xD;
         14. Requiring treatment with any of the prohibited concomitant medications.&#xD;
&#xD;
         15. Known or suspected hypersensitivity to study drug or excipients.&#xD;
&#xD;
         16. Received an investigational drug within 30 days of the screening visit (12 weeks if an&#xD;
             oral or injectable steroid).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Fitzroy</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wellington</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>China</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>March 27, 2017</last_update_submitted>
  <last_update_submitted_qc>March 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <keyword>FEV1 ≤ 50%</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <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>Fluticasone-Salmeterol Drug Combination</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 28, 2019</submitted>
    <returned>June 20, 2019</returned>
  </pending_results>
  <!-- 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/NCT02195375
org study id: FLT3510
nct id: NCT02195375
lead sponsor: 
The purpose of this study is to investigate whether flutiform® is effective and safe in the
      treatment of chronic obstructive pulmonary disease (COPD).
A multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group
      study in male and female subjects conducted to assess the efficacy and safety of flutiform in
      the treatment of COPD. Subjects will be randomised to one of three treatment groups in a
      1:1:1 ratio. Throughout the study subjects will be assessed on a mixture of symptom based and
      lung function measurements to monitor their progress in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Average pre-dose FEV1
time frame: 26 weeks
measure: Average 1 hour Post dose FEV1, FVC, FEV6
time frame: 26 Weeks
measure: Moderate and Severe COPD Exacerbations
time frame: 26 weeks
measure: COPD Assessment Test
time frame: Change from baseline to week 8, week 14, week 26
measure: Average capacity of daily living during the morning score
time frame: 26 weeks
arm group label: Flutiform 500/20 µg BID
arm group type: Experimental
description: Flutiform 250/10 (2 puffs BID)
arm group label: Flutiform 250/10 µg BID
arm group type: Experimental
description: Flutiform 125/5 (2 puffs BID)
arm group label: Seretide Accuhaler 50/500 µg BID
arm group type: Active Comparator
description: Seretide Accuhaler 50/500 (BID)
intervention type: Drug
intervention name: Flutiform 500/20 µg BID
arm group label: Flutiform 500/20 µg BID
intervention type: Drug
intervention name: Flutiform 250/10 µg BID
arm group label: Flutiform 250/10 µg BID
intervention type: Drug
intervention name: Seretide Accuhaler 50/500 µg BID
arm group label: Seretide Accuhaler 50/500 µg BID
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: China
country: Korea, Republic of
country: New Zealand
country: Taiwan
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Fluticasone-Salmeterol Drug Combination
submitted: March 28, 2019
returned: June 20, 2019