<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/NCT03299673</url>
  </required_header>
  <id_info>
    <org_study_id>2017-HAL-EL-75</org_study_id>
    <nct_id>NCT03299673</nct_id>
  </id_info>
  <brief_title>AdHerencE to Treatment and quAlity of Life in COPD</brief_title>
  <acronym>AHEAD</acronym>
  <official_title>Observational Study to Investigate the Compliance of Patients With COPD With the 8-item Morisky Medication Adherence Scale and Assessing the Quality of Life of Patients as Shown by the Clinical COPD Questionnaire (CCQ) Questionnaire.</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>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>
      The present non-interventional observational study in the Greek population aims at collecting&#xD;
      the characteristics of COPD patients selected to be given the inhaled combination of&#xD;
      fluticasone propionate and salmeterol in doses of 100 μg mcg (250 μg) mcg (500 g) mcg through&#xD;
      the Elpenhaler® device, to investigate (a) the effectiveness of the treatment for compliance&#xD;
      and the quality of life of the patients; and (b) the safety of the drugs in patients whose&#xD;
      disease is treated either in a hospital or in a private physician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rolenium® is an inhalable combination the active ingredients of which is the inhaled&#xD;
      combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg,&#xD;
      (500 + 50) mcg administered via the Elpenhaler ®, developed by ELPEN. It has been approved as&#xD;
      a bronchodilator therapy for COPD (a fast-exiting volume in the first second (FEV1) after a&#xD;
      bronchodilator less than 60% predicted) with a history of repeated seizures that have&#xD;
      significant symptoms despite regular bronchodilator therapy. For COPD in adults an inhalation&#xD;
      of 500 micrograms of fluticasone propionate and 50 micrograms of salmeterol twice daily is&#xD;
      recommended4. More information on the efficacy and safety of the investigational medicinal&#xD;
      product is provided in the Summary of Product Characteristics (SPC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">December 5, 2018</completion_date>
  <primary_completion_date type="Actual">December 5, 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>Quality of Life</measure>
    <time_frame>3 months</time_frame>
    <description>Change in CCQ scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>3 months</time_frame>
    <description>Change in MMAS-8 item scale</description>
  </secondary_outcome>
  <enrollment type="Actual">600</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Compliance, Patient</condition>
  <condition>Quality of Life</condition>
  <eligibility>
    <study_pop>
      <textblock>
        COPD patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients to be started on Rolenium®, an inhaled combination of fluticasone propionate&#xD;
             and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg, (500 + 50) mcg administered&#xD;
             via the Elpenhaler®&#xD;
&#xD;
          -  Patients who should be diagnosed with severe COPD and FEV1 &lt;60% of the expected normal&#xD;
             rate and a history of repeated exacerbations that have significant symptoms despite&#xD;
             regular bronchodilator therapy:&#xD;
&#xD;
               1. Single LABA bronchoconstriction&#xD;
&#xD;
               2. Under dual bronchoconstriction LABA / LAMA&#xD;
&#xD;
               3. Never have received inhaled or systemic corticosteroids (ICS)&#xD;
&#xD;
               4. Previous ICS use in the past may be present, as long as the patient is not in the&#xD;
                  same treatment for the last three months.&#xD;
&#xD;
          -  Male or female patients over 18 years of age&#xD;
&#xD;
          -  Compliance with treatment&#xD;
&#xD;
          -  Compliance with study procedures&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men or women under 18 years of age&#xD;
&#xD;
          -  Non-compliance with treatment&#xD;
&#xD;
          -  Inappropriate use of inhaled therapies&#xD;
&#xD;
          -  Non-compliance in study procedures&#xD;
&#xD;
          -  Unsigned patient consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Evagelismos hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03299673
org study id: 2017-HAL-EL-75
nct id: NCT03299673
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present non-interventional observational study in the Greek population aims at collecting
      the characteristics of COPD patients selected to be given the inhaled combination of
      fluticasone propionate and salmeterol in doses of 100 μg mcg (250 μg) mcg (500 g) mcg through
      the Elpenhaler® device, to investigate (a) the effectiveness of the treatment for compliance
      and the quality of life of the patients; and (b) the safety of the drugs in patients whose
      disease is treated either in a hospital or in a private physician.
Rolenium® is an inhalable combination the active ingredients of which is the inhaled
      combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg,
      (500 + 50) mcg administered via the Elpenhaler ®, developed by ELPEN. It has been approved as
      a bronchodilator therapy for COPD (a fast-exiting volume in the first second (FEV1) after a
      bronchodilator less than 60% predicted) with a history of repeated seizures that have
      significant symptoms despite regular bronchodilator therapy. For COPD in adults an inhalation
      of 500 micrograms of fluticasone propionate and 50 micrograms of salmeterol twice daily is
      recommended4. More information on the efficacy and safety of the investigational medicinal
      product is provided in the Summary of Product Characteristics (SPC).
observational model: Other
time perspective: Prospective
measure: Quality of Life
time frame: 3 months
description: Change in CCQ scale
measure: Compliance
time frame: 3 months
description: Change in MMAS-8 item scale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Undecided