<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/NCT03300076</url>
  </required_header>
  <id_info>
    <org_study_id>2017-HAL-EL-74</org_study_id>
    <nct_id>NCT03300076</nct_id>
  </id_info>
  <brief_title>COMPLliancE and qualiTy of lifE in Asthma</brief_title>
  <acronym>COMPLETE</acronym>
  <official_title>Multicenter, Open-label, Non Interventional, Prospective, Observational Clinical Trial to Assess the Compliance and Quality of Life in Greek Asthmatic Patients</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>
      A multicenter, open, non-interventional, prospective, clinical observational study on&#xD;
      Conformity to Therapy and Quality of Life in Asthma in patients living in Greece&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dry powder devices, available since 1970, have been developed to make inhalation simpler than&#xD;
      pMDIs and relieve the need for co-ordination of spraying and inhalation, which is&#xD;
      particularly important for patient groups such as the elderly and children. In addition, dry&#xD;
      powder devices do not contain propellant gases potentially hostile to the environment as they&#xD;
      are activated by inhalation of the patient and do not cause cold sensation upon inhalation.&#xD;
&#xD;
      Today, the combination of inhaled corticosteroid (ICS) and long-acting β2-inducer with an&#xD;
      inhaler is the basic treatment for asthma6.&#xD;
&#xD;
      The addition of long-acting β2-inducer (LABA) to a daily inhaled corticosteroid regimen1:&#xD;
&#xD;
        -  Improves the symptoms,&#xD;
&#xD;
        -  Reduces nightly asthma symptoms,&#xD;
&#xD;
        -  Improves pulmonary function,&#xD;
&#xD;
        -  Reduces the use of β2-agonists for rapid action,&#xD;
&#xD;
        -  Reduces the number of seizures,&#xD;
&#xD;
        -  Does not increase the risk of hospitalizations due to asthma,&#xD;
&#xD;
        -  Achieves clinical asthma control in more patients, faster and with less ICS than would&#xD;
           be required if ICS were administered alone.&#xD;
&#xD;
      The greater effectiveness of combination therapy has led to the development of stable&#xD;
      combination inhalers that both glucocorticosteroids and LABA (eg, fluticasone-salmeterol,&#xD;
      budesonide-formoterol stable compounds) are concomitantly conveyed.&#xD;
&#xD;
      Stable combinations are more user-friendly for patients, potentially increasing compliance,&#xD;
      and ensure that LABA is always accompanied by glucocorticosteroid1. Of the combinations&#xD;
      available, the budesonide-formoterol combination can be used both as maintenance therapy and&#xD;
      symptom relief due to the rapid onset of formoterol compared to salmeterol. Both components&#xD;
      of the budesonide-formoterol combination when administered are helpful in enhancing&#xD;
      protection from severe seizures in patients receiving combination therapy for maintenance and&#xD;
      improve the control of asthma at relatively low ICS doses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 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>6 months</time_frame>
    <description>Change in mini AQLQ scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>6 months</time_frame>
    <description>Change in MMAS-8 scale</description>
  </secondary_outcome>
  <enrollment type="Actual">800</enrollment>
  <condition>Asthma</condition>
  <condition>Compliance, Patient</condition>
  <condition>Quality of Life</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Asthmatic adult patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female asthma 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;
          -  Patients not satisfactorily controlled with inhaled corticosteroids and the use of&#xD;
             inhaled short-acting β2-primers or patients already adequately controlled with both&#xD;
             inhaled corticosteroids and long-acting β2-stimulants:&#xD;
&#xD;
               1. Patients receiving ICS inhaled and SABA invoked&#xD;
&#xD;
               2. Patients receiving inhaled ICS and LABA with separate devices each&#xD;
&#xD;
               3. Patients receiving periodic and not continuously stable combination of ICS and&#xD;
                  LABA but not being treated for at least 1 month&#xD;
&#xD;
               4. Patients who did not receive any treatment and the doctor decides to immediately&#xD;
                  start the fixed combination of ICS and LABA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male or female asthma patients under 18 years of age&#xD;
&#xD;
          -  Unsigned patient consent&#xD;
&#xD;
          -  Non-compliance with treatment&#xD;
&#xD;
          -  Non-compliance in study procedures&#xD;
&#xD;
          -  COPD patients (at any stage)&#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>Sotiria Pulmonary Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>March 2018</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>Asthma</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/NCT03300076
org study id: 2017-HAL-EL-74
nct id: NCT03300076
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A multicenter, open, non-interventional, prospective, clinical observational study on
      Conformity to Therapy and Quality of Life in Asthma in patients living in Greece
Dry powder devices, available since 1970, have been developed to make inhalation simpler than
      pMDIs and relieve the need for co-ordination of spraying and inhalation, which is
      particularly important for patient groups such as the elderly and children. In addition, dry
      powder devices do not contain propellant gases potentially hostile to the environment as they
      are activated by inhalation of the patient and do not cause cold sensation upon inhalation.

      Today, the combination of inhaled corticosteroid (ICS) and long-acting β2-inducer with an
      inhaler is the basic treatment for asthma6.

      The addition of long-acting β2-inducer (LABA) to a daily inhaled corticosteroid regimen1:

        -  Improves the symptoms,

        -  Reduces nightly asthma symptoms,

        -  Improves pulmonary function,

        -  Reduces the use of β2-agonists for rapid action,

        -  Reduces the number of seizures,

        -  Does not increase the risk of hospitalizations due to asthma,

        -  Achieves clinical asthma control in more patients, faster and with less ICS than would
           be required if ICS were administered alone.

      The greater effectiveness of combination therapy has led to the development of stable
      combination inhalers that both glucocorticosteroids and LABA (eg, fluticasone-salmeterol,
      budesonide-formoterol stable compounds) are concomitantly conveyed.

      Stable combinations are more user-friendly for patients, potentially increasing compliance,
      and ensure that LABA is always accompanied by glucocorticosteroid1. Of the combinations
      available, the budesonide-formoterol combination can be used both as maintenance therapy and
      symptom relief due to the rapid onset of formoterol compared to salmeterol. Both components
      of the budesonide-formoterol combination when administered are helpful in enhancing
      protection from severe seizures in patients receiving combination therapy for maintenance and
      improve the control of asthma at relatively low ICS doses.
observational model: Other
time perspective: Prospective
measure: Quality of Life
time frame: 6 months
description: Change in mini AQLQ scale
measure: Compliance
time frame: 6 months
description: Change in MMAS-8 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: Asthma