<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/NCT02978703</url>
  </required_header>
  <id_info>
    <org_study_id>2016-HAL-EL-67</org_study_id>
    <nct_id>NCT02978703</nct_id>
  </id_info>
  <brief_title>EvAluation of Clinical Effectiveness Of RoLenium Administered With Elpenhaler in Chronic Obstructive Pulmonary Disease (COPD) patientS in Daily Clinical Practice, in Greece</brief_title>
  <acronym>AEOLOS</acronym>
  <official_title>Non Interventional, Observational, Multi-center Study to Evaluate the Efficacy and Safety of Fluticasone/Salmeterol (Rolenium / Elpenhaler Administration in Greek COPD Pattients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elpen Pharmaceutical Co. Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elpen Pharmaceutical Co. Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational study for the evaluation of clinical effectiveness in daily clinical practice&#xD;
      of inhaled combination of propionic Fluticasone and Salmeterol in doses (500+50)mcg -&#xD;
      Rolenium- administered with Elpenhaler device in approximately 2000 COPD (Chronic Obstructive&#xD;
      Pulmonary Disease) patients with a FEV1 &lt;50% predicted normal (pre-bronchodilator), a history&#xD;
      of repeated exacerbations and who have significant symptoms despite regular bronchodilator&#xD;
      therapy in Greece.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The scientific Objectives are to study in the Greek population the real-life patient&#xD;
      characteristics of patients selected for treatment with the inhaled combination of propionic&#xD;
      Fluticasone and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device and&#xD;
      the performance of this inhaled combination in terms of effectiveness and safety in&#xD;
      approximately 2500 COPD (Chronic Obstructive Pulmonary Disease) patients with a FEV1 &lt;50%&#xD;
      predicted normal (pre-bronchodilator), a history of repeated exacerbations and who have&#xD;
      significant symptoms despite regular bronchodilator therapy treated in Hospital and&#xD;
      outpatient specialist ward settings, in the daily clinical practice&#xD;
&#xD;
      The primary endpoints for the study are:&#xD;
&#xD;
      • Change in FEV1, FVC, FEV1/FVC from baseline to 12 months (±2 weeks) from starting taking&#xD;
      Rolenium®.&#xD;
&#xD;
      The Secondary endpoints for the study are:&#xD;
&#xD;
        -  Change in lung function parameters from baseline to month 6 (±2 weeks) from start of&#xD;
           Rolenium® treatment&#xD;
&#xD;
        -  Incidence and frequency of exacerbations&#xD;
&#xD;
        -  Hospitalizations due to COPD exacerbation&#xD;
&#xD;
        -  Change in MRC Dyspnea index.&#xD;
&#xD;
        -  Patient's satisfaction with the use of Elpenhaler device assessed with FSI 10&#xD;
           Questionnaire after 6 months and after 12 months (±2 weeks).&#xD;
&#xD;
        -  Concomitant administration of inhaled bronchodilators&#xD;
&#xD;
        -  ADRs during the treatment period (only via the post-marketing procedure). Methodology&#xD;
           The study will be a purely observational, prospective study, collecting data on patient&#xD;
           treated with the inhaled combination of propionic Fluticasone and Salmeterol (500+50)&#xD;
           mcg,- administered with Elpenhaler device in Greece without any interference with the&#xD;
           treatment practices of the physicians involved in the data collection. Thus patients&#xD;
           will only be considered for inclusion after the decision has been taken to treat them&#xD;
           with inhaled combination of propionic Fluticasone and Salmeterol (500+50) mcg&#xD;
           administered with Elpenhaler device and no visits, diagnostic procedures or monitoring&#xD;
           will take place which would not happen had the patient not been included in the study.&#xD;
           This means that only data generated in usual daily clinical practice will be collected&#xD;
           in the study, so that no extra examinations or study visits will take place due to the&#xD;
           study. The study will not be comparative; only inhaled combination of propionic&#xD;
           Fluticasone and Salmeterol (500+50)mcg,- administered with Elpenhaler device will be&#xD;
           included. Consecutive patients who are to start the inhaled combination of propionic&#xD;
           Fluticasone and Salmeterol (500+50) mcg,- administered with Elpenhaler device treatment&#xD;
           shall be informed about the study and asked for consent. Following usual practice the&#xD;
           patients will be followed after 6 months and after 12 months (±2 weeks) of the inhaled&#xD;
           treatment.&#xD;
&#xD;
      The patients' selection criteria will be according to SmPC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy assessed by Spirometry</measure>
    <time_frame>12 months</time_frame>
    <description>Spirometry: Change in FEV1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy assessed by MRC dyspnea questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>MRC Dyspnea questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by number of exacerbations</measure>
    <time_frame>0,6,12 months</time_frame>
    <description>Incidence of exacerbations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction assessed by FSI-10 questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>FSI-10 questionnaire score per patient per study visit</description>
  </secondary_outcome>
  <enrollment type="Actual">1730</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>COPD Pharmacologic Substance</intervention_name>
    <description>COPD patients treated by Fluticasone / Salmetrol via Elpenhaler device</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        COPD patients will be recruited in the study. The patients will be diagnosed with COPD with&#xD;
        a FEV1 &lt;50% predicted normal (pre-bronchodilator) in need of symptomatic treatment and a&#xD;
        history of repeated exacerbations, who have significant symptoms despite regular&#xD;
        bronchodilator therapy.&#xD;
&#xD;
        The study will be conducted in about 100 sites in Greece. 5 study sites will be Hospitals&#xD;
        and 75 study sites will be pulmonologists in private practice.&#xD;
&#xD;
        The investigators will be Pulmonologists.&#xD;
&#xD;
        Patients that are to start treatment with the inhaled combination of propionic Fluticazone&#xD;
        and Salmeterol in doses (250+50)mcg, (500+50)mcg are eligible for inclusion in the study.&#xD;
        In accordance with the approved labelling these patients should:&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients selected for treatment with the inhaled combination of propionic Fluticasone&#xD;
             and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device&#xD;
&#xD;
          -  FEV1 &lt;50% predicted normal (pre-bronchodilator),&#xD;
&#xD;
          -  a history of repeated exacerbations who have significant symptoms despite regular&#xD;
             bronchodilator therapy treated in Hospital outpatient specialist ward settings, in the&#xD;
             daily clinical practice&#xD;
&#xD;
          -  have signed informed consent&#xD;
&#xD;
          -  be compliant with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - patients not selected for treatment with the inhaled combination of propionic&#xD;
&#xD;
          -  FEV1 &gt;50% predicted normal (pre-bronchodilator),&#xD;
&#xD;
          -  no history of repeated exacerbations&#xD;
&#xD;
          -  not signed informed consent&#xD;
&#xD;
          -  will not be compliant with study procedures&#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>Nikolaos Tzanakis, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Herakleion, Crete</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Crete</name>
      <address>
        <city>Iraklion</city>
        <state>Crete</state>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Herakleion</name>
      <address>
        <city>Irákleion</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>May 10, 2019</last_update_submitted>
  <last_update_submitted_qc>May 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</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</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02978703
org study id: 2016-HAL-EL-67
nct id: NCT02978703
lead sponsor: 
has dmc: Yes
Observational study for the evaluation of clinical effectiveness in daily clinical practice
      of inhaled combination of propionic Fluticasone and Salmeterol in doses (500+50)mcg -
      Rolenium- administered with Elpenhaler device in approximately 2000 COPD (Chronic Obstructive
      Pulmonary Disease) patients with a FEV1 <50% predicted normal (pre-bronchodilator), a history
      of repeated exacerbations and who have significant symptoms despite regular bronchodilator
      therapy in Greece.
The scientific Objectives are to study in the Greek population the real-life patient
      characteristics of patients selected for treatment with the inhaled combination of propionic
      Fluticasone and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device and
      the performance of this inhaled combination in terms of effectiveness and safety in
      approximately 2500 COPD (Chronic Obstructive Pulmonary Disease) patients with a FEV1 <50%
      predicted normal (pre-bronchodilator), a history of repeated exacerbations and who have
      significant symptoms despite regular bronchodilator therapy treated in Hospital and
      outpatient specialist ward settings, in the daily clinical practice

      The primary endpoints for the study are:

      • Change in FEV1, FVC, FEV1/FVC from baseline to 12 months (±2 weeks) from starting taking
      Rolenium®.

      The Secondary endpoints for the study are:

        -  Change in lung function parameters from baseline to month 6 (±2 weeks) from start of
           Rolenium® treatment

        -  Incidence and frequency of exacerbations

        -  Hospitalizations due to COPD exacerbation

        -  Change in MRC Dyspnea index.

        -  Patient's satisfaction with the use of Elpenhaler device assessed with FSI 10
           Questionnaire after 6 months and after 12 months (±2 weeks).

        -  Concomitant administration of inhaled bronchodilators

        -  ADRs during the treatment period (only via the post-marketing procedure). Methodology
           The study will be a purely observational, prospective study, collecting data on patient
           treated with the inhaled combination of propionic Fluticasone and Salmeterol (500+50)
           mcg,- administered with Elpenhaler device in Greece without any interference with the
           treatment practices of the physicians involved in the data collection. Thus patients
           will only be considered for inclusion after the decision has been taken to treat them
           with inhaled combination of propionic Fluticasone and Salmeterol (500+50) mcg
           administered with Elpenhaler device and no visits, diagnostic procedures or monitoring
           will take place which would not happen had the patient not been included in the study.
           This means that only data generated in usual daily clinical practice will be collected
           in the study, so that no extra examinations or study visits will take place due to the
           study. The study will not be comparative; only inhaled combination of propionic
           Fluticasone and Salmeterol (500+50)mcg,- administered with Elpenhaler device will be
           included. Consecutive patients who are to start the inhaled combination of propionic
           Fluticasone and Salmeterol (500+50) mcg,- administered with Elpenhaler device treatment
           shall be informed about the study and asked for consent. Following usual practice the
           patients will be followed after 6 months and after 12 months (±2 weeks) of the inhaled
           treatment.

      The patients' selection criteria will be according to SmPC.
observational model: Other
time perspective: Prospective
measure: Efficacy assessed by Spirometry
time frame: 12 months
description: Spirometry: Change in FEV1
measure: Efficacy assessed by MRC dyspnea questionnaire
time frame: 12 months
description: MRC Dyspnea questionnaire
measure: Safety assessed by number of exacerbations
time frame: 0,6,12 months
description: Incidence of exacerbations
measure: Patient Satisfaction assessed by FSI-10 questionnaire
time frame: 12 months
description: FSI-10 questionnaire score per patient per study visit
intervention type: Drug
intervention name: COPD Pharmacologic Substance
description: COPD patients treated by Fluticasone / Salmetrol via Elpenhaler device
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nikolaos Tzanakis, MD
role: Study Chair
affiliation: University of Herakleion, Crete
facility: 
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No