<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/NCT03033758</url>
  </required_header>
  <id_info>
    <org_study_id>2016-HAL-EL-69</org_study_id>
    <nct_id>NCT03033758</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effectiveness and Quality of Life With the Administration of the Fixed Combination of Budesonide Formoterol in Greek Patients With Asthma During Routine Clinical Practice.</brief_title>
  <acronym>BOREAS</acronym>
  <official_title>Observational Study to Evaluate the Clinical Efficacy and Improved Quality of Life With the Administration of the Fixed Combination of Budesonide Formoterol, in Approximately 2000 Patients With Asthma</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>
      This study will be conducted in Greek population. The patients who will be selected for study&#xD;
      enrollment will receive inhaled combination of budesonide and formoterol fumarate dihydrate&#xD;
      at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg through Elpenhlaler® device. The study end points&#xD;
      will be efficacy and safety in patients with asthma.Additional study objectives will be&#xD;
      quality of life, patient satisfaction, severe exacerbation and comorbidities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is a heterogeneous disease, usually characterized by chronic inflammation of the&#xD;
      airways. Characterized by a history of respiratory symptoms such as wheezing, chest heaviness&#xD;
      and cough symptoms that fluctuate over time, as well as variable airway obstruction.&#xD;
&#xD;
      Asthma is a common disease worldwide, the rates of which are increasing in children and&#xD;
      adults. It is estimated that asthma affects 1-18% of the population in different countries.&#xD;
      In Greece, which is a country with lower rates of asthma, it is estimated that 8.6% of the&#xD;
      population suffers from the disease.&#xD;
&#xD;
      The diagnosis of asthma should be based on: Background with characteristic symptoms, signs&#xD;
      variable airway obstruction, with tests for reversal of bronchial obstruction or other tests.&#xD;
&#xD;
      Long-term treatment of asthma has the following objectives 1. symptom control: achieve&#xD;
      adequate control of symptoms and maintain normal activity levels 2. Risk Reduction: minimize&#xD;
      risk of future exacerbations, permanent airflow obstruction and side effects from medication&#xD;
      Pulmoton® is an inhaled combination of budesonide and formoterol fumarate dihydrate in&#xD;
      portions 100 / 6mcg, 200 / 6mcg, 400/12 mcg, administered through Elpenhlaler® device,&#xD;
      developed by ELPEN. It is approved as a bronchodilator in the treatment of asthma where&#xD;
      administration of the combination (inhaled corticosteroid and long-beta2-agonist action) is&#xD;
      appropriate in patients not adequately controlled with inhaled corticosteroids and 'as&#xD;
      needed' inhaled beta2-agonists short-acting or patients already adequately controlled with&#xD;
      both inhaled corticosteroids and long-acting beta2-agonists.&#xD;
&#xD;
      Pulmoton® not recommended for the initial treatment of asthma. The dosage of the individual&#xD;
      components of Pulmoton® is separate and must be adjusted according to the severity of the&#xD;
      condition. This should be considered not only at the beginning of therapy with fixed&#xD;
      combination products, but also when adjusting the maintenance dosage.&#xD;
&#xD;
      The dose should be adjusted to the lowest possible, to achieve and maintain effective control&#xD;
      of symptoms. Patients should be regularly reassessed by a doctor, so that the dose of&#xD;
      Pulmoton® receiving remains optimal. When you achieve long-term control of symptoms with the&#xD;
      lowest recommended dose, then the next step may be testing single administration of inhaled&#xD;
      corticosteroid.&#xD;
&#xD;
      There are two alternatives for the treatment of asthma with Pulmoton®:&#xD;
&#xD;
      A. Pulmoton® maintenance therapy: Pulmoton® taken as regular maintenance treatment with a&#xD;
      separate rapid-acting bronchodilator for relief of symptoms.&#xD;
&#xD;
      B. Pulmoton® maintenance and reliever therapy: Pulmoton® taken as regular maintenance and 'on&#xD;
      demand' therapy to treat the symptoms.&#xD;
&#xD;
      A. Pulmoton® maintenance therapy:&#xD;
&#xD;
      Patients should be advised to always carry with them their fast-acting bronchodilator to use&#xD;
      when there is a need for relief.&#xD;
&#xD;
      More information on the effectiveness and safety of the study drug, reported in the Summary&#xD;
      of Product Characteristics (Summary of Product Characteristics (SmPC)&#xD;
&#xD;
      This prospective observational study aims to collect data regarding Pulmoton® from everyday&#xD;
      clinical practice, improve the quality of life of patients and disease progression. The&#xD;
      centers where the study will be approximately 100, both hospital and private pulmonary&#xD;
      clinics will be held. Data will be collected for a period of 6 months from patients diagnosed&#xD;
      with asthma not adequately controlled with inhaled corticosteroids and 'as needed' inhaled&#xD;
      beta2-agonists short-acting or patients already adequately controlled on both inhaled&#xD;
      corticosteroids and beta2-long-acting stimulants.&#xD;
&#xD;
      Data will be collected during the period of three (3) and six (6) months (± 2 weeks) from the&#xD;
      initiation of treatment with inhaled combination include spirometry data, (FEV1, FVC, FEV /&#xD;
      FVC), checklist ACQ, AQLQ questionnaire and questionnaire FSI 10, and details of any existing&#xD;
      comorbidities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</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>ACQ (change)</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of asthma control by varying the ACQ questionnaire from the start of treatment with Pulmoton® up over 6 months (± 2 weeks)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FEV1 (change)</measure>
    <time_frame>6 months</time_frame>
    <description>The change in FEV1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (change)</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of the quality of life of patients by changing the AQLQ questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FSI-10 (change)</measure>
    <time_frame>3 months</time_frame>
    <description>Satisfaction of the patient to treatment with the inhaled combination budesonide formoterol through Elpenhlaler® device in either of the two dosages, after 3 months of treatment via FSI questionnaire 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of Adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>The incidence and frequency of exacerbations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comorbidities</measure>
    <time_frame>6 months</time_frame>
    <description>Recording of comorbidities which may exist and are known and the estimated change in the respective biochemical markers where they exist and are available)</description>
  </secondary_outcome>
  <enrollment type="Actual">980</enrollment>
  <condition>Asthma</condition>
  <condition>Quality of Life</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Budesonide/Formoterol treated patients</intervention_name>
    <description>patients who are eligible to start their treatment with budesonide/formoterol therapy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients about to start treatment with the inhaled combination of budesonide and formoterol&#xD;
        fumarate dihydrate at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg, through Elpenhlaler device&#xD;
        may be included in the study. Under current SPC, the Pulmoton indicated in the regular&#xD;
        treatment of asthma, wherein the administration of the combination (inhaled corticosteroid&#xD;
        and long-action beta2-agonist) is appropriate :&#xD;
&#xD;
          -  in patients not adequately controlled with inhaled corticosteroids and 'as needed'&#xD;
             inhaled beta2-agonists short-acting&#xD;
&#xD;
          -  in patients already adequately controlled on both inhaled corticosteroids and&#xD;
             long-acting beta2-agonists.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and Female&#xD;
&#xD;
          -  Patients about to start treatment with the inhaled combination of budesonide and&#xD;
             formoterol fumarate dihydrate at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg, through&#xD;
             Elpenhlaler device&#xD;
&#xD;
          -  Regular treatment of asthma, wherein the administration of the combination (inhaled&#xD;
             corticosteroid and long-action beta2-agonist) is appropriate&#xD;
&#xD;
          -  Patients not adequately controlled with inhaled corticosteroids and 'as needed'&#xD;
             inhaled beta2-agonists short-acting&#xD;
&#xD;
          -  Patients who signed Informed Consent Patients eligible to follow the study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who will be treated out of SpC&#xD;
&#xD;
          -  Patients without Informed Consent&#xD;
&#xD;
          -  Patients not eligible to follow the 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>
  <location>
    <facility>
      <name>7th Pulmonary Dept, Athens Chest Hospital</name>
      <address>
        <city>Athens</city>
        <state>Mesogion Ave. 152</state>
        <zip>Athens 11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.18332/pne/144485</url>
    <description>DOI: https://doi.org/10.18332/pne/144485</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>comorbidities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
    <mesh_term>Formoterol Fumarate</mesh_term>
  </intervention_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/NCT03033758
org study id: 2016-HAL-EL-69
nct id: NCT03033758
lead sponsor: 
has dmc: Yes
This study will be conducted in Greek population. The patients who will be selected for study
      enrollment will receive inhaled combination of budesonide and formoterol fumarate dihydrate
      at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg through Elpenhlaler® device. The study end points
      will be efficacy and safety in patients with asthma.Additional study objectives will be
      quality of life, patient satisfaction, severe exacerbation and comorbidities.
Asthma is a heterogeneous disease, usually characterized by chronic inflammation of the
      airways. Characterized by a history of respiratory symptoms such as wheezing, chest heaviness
      and cough symptoms that fluctuate over time, as well as variable airway obstruction.

      Asthma is a common disease worldwide, the rates of which are increasing in children and
      adults. It is estimated that asthma affects 1-18% of the population in different countries.
      In Greece, which is a country with lower rates of asthma, it is estimated that 8.6% of the
      population suffers from the disease.

      The diagnosis of asthma should be based on: Background with characteristic symptoms, signs
      variable airway obstruction, with tests for reversal of bronchial obstruction or other tests.

      Long-term treatment of asthma has the following objectives 1. symptom control: achieve
      adequate control of symptoms and maintain normal activity levels 2. Risk Reduction: minimize
      risk of future exacerbations, permanent airflow obstruction and side effects from medication
      Pulmoton® is an inhaled combination of budesonide and formoterol fumarate dihydrate in
      portions 100 / 6mcg, 200 / 6mcg, 400/12 mcg, administered through Elpenhlaler® device,
      developed by ELPEN. It is approved as a bronchodilator in the treatment of asthma where
      administration of the combination (inhaled corticosteroid and long-beta2-agonist action) is
      appropriate in patients not adequately controlled with inhaled corticosteroids and 'as
      needed' inhaled beta2-agonists short-acting or patients already adequately controlled with
      both inhaled corticosteroids and long-acting beta2-agonists.

      Pulmoton® not recommended for the initial treatment of asthma. The dosage of the individual
      components of Pulmoton® is separate and must be adjusted according to the severity of the
      condition. This should be considered not only at the beginning of therapy with fixed
      combination products, but also when adjusting the maintenance dosage.

      The dose should be adjusted to the lowest possible, to achieve and maintain effective control
      of symptoms. Patients should be regularly reassessed by a doctor, so that the dose of
      Pulmoton® receiving remains optimal. When you achieve long-term control of symptoms with the
      lowest recommended dose, then the next step may be testing single administration of inhaled
      corticosteroid.

      There are two alternatives for the treatment of asthma with Pulmoton®:

      A. Pulmoton® maintenance therapy: Pulmoton® taken as regular maintenance treatment with a
      separate rapid-acting bronchodilator for relief of symptoms.

      B. Pulmoton® maintenance and reliever therapy: Pulmoton® taken as regular maintenance and 'on
      demand' therapy to treat the symptoms.

      A. Pulmoton® maintenance therapy:

      Patients should be advised to always carry with them their fast-acting bronchodilator to use
      when there is a need for relief.

      More information on the effectiveness and safety of the study drug, reported in the Summary
      of Product Characteristics (Summary of Product Characteristics (SmPC)

      This prospective observational study aims to collect data regarding Pulmoton® from everyday
      clinical practice, improve the quality of life of patients and disease progression. The
      centers where the study will be approximately 100, both hospital and private pulmonary
      clinics will be held. Data will be collected for a period of 6 months from patients diagnosed
      with asthma not adequately controlled with inhaled corticosteroids and 'as needed' inhaled
      beta2-agonists short-acting or patients already adequately controlled on both inhaled
      corticosteroids and beta2-long-acting stimulants.

      Data will be collected during the period of three (3) and six (6) months (± 2 weeks) from the
      initiation of treatment with inhaled combination include spirometry data, (FEV1, FVC, FEV /
      FVC), checklist ACQ, AQLQ questionnaire and questionnaire FSI 10, and details of any existing
      comorbidities.
observational model: Other
time perspective: Prospective
measure: ACQ (change)
time frame: 6 months
description: Evaluation of asthma control by varying the ACQ questionnaire from the start of treatment with Pulmoton® up over 6 months (± 2 weeks)
measure: FEV1 (change)
time frame: 6 months
description: The change in FEV1
measure: Quality of Life (change)
time frame: 6 months
description: Evaluation of the quality of life of patients by changing the AQLQ questionnaire
measure: FSI-10 (change)
time frame: 3 months
description: Satisfaction of the patient to treatment with the inhaled combination budesonide formoterol through Elpenhlaler® device in either of the two dosages, after 3 months of treatment via FSI questionnaire 10
measure: number of Adverse events
time frame: 6 months
description: The incidence and frequency of exacerbations
measure: Comorbidities
time frame: 6 months
description: Recording of comorbidities which may exist and are known and the estimated change in the respective biochemical markers where they exist and are available)
intervention type: Other
intervention name: Budesonide/Formoterol treated patients
description: patients who are eligible to start their treatment with budesonide/formoterol therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Greece
url: https://doi.org/10.18332/pne/144485
description: DOI: https://doi.org/10.18332/pne/144485
responsible party type: Sponsor
mesh term: Asthma
mesh term: Budesonide
mesh term: Formoterol Fumarate
sharing ipd: No