<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/NCT02187926</url>
  </required_header>
  <id_info>
    <org_study_id>RO-2455-401-GR</org_study_id>
    <nct_id>NCT02187926</nct_id>
  </id_info>
  <brief_title>Evaluation of Clinical Effectiveness of Roflumilast in Routine Practice, in Chronic Obstructive Pulmonary Disease (COPD) Patients in Greece</brief_title>
  <acronym>ATLAS</acronym>
  <official_title>Observational Study for the Evaluation of Clinical Effectiveness in Routine Practice of Daxas® (Roflumilast), in Approximately 2700 Patients With Severe and Very Severe COPD (Chronic Obstructive Pulmonary Disease) in Greece</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to examine the characteristics of patients selected for&#xD;
      treatment with roflumilast and the effectiveness and safety of roflumilast in patients with&#xD;
      severe or very severe COPD treated in Hospital and outpatient specialist ward settings in&#xD;
      Greece.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being observed in this study is called roflumilast. Roflumilast is used to treat&#xD;
      people who have chronic obstructive pulmonary disease (COPD) associated with chronic&#xD;
      bronchitis with a history of worsening symptoms. This study looked at side effects and the&#xD;
      lung function of people who take roflumilast. The study enrolled 2577 patients who were&#xD;
      already prescribed roflumilast as an add on to bronchiodilator treatment by their healthcare&#xD;
      provider. This multi-centre trial was conducted in Greece. The overall time to participate in&#xD;
      this study was up to 6 months. Participants were evaluated during routine appointments with&#xD;
      their healthcare provider.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Forced Vital Capacity (FVC) at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Chronic Obstructive Pulmonary Disease (COPD) Exacerbations</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>A COPD exacerbation is an event characterised by a worsening in the patient's baseline dyspnoea, or cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management, and may be accompanied by increased wheeze, chest tightness, purulent sputum and symptoms of cold and/or fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants requiring Hospitalizations due to Exacerbations of COPD</measure>
    <time_frame>Up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Clinical COPD Questionnaire (CCQ) Total Score</measure>
    <time_frame>Baseline and Months 3 and 6</time_frame>
    <description>Quality of life will be evaluated using the Clinical COPD Questionnaire (CCQ) 10-item questionnaire. The questions in the CCQ are divided into three area's, or domains: Symptoms: items 1, 2, 5 and 6; Functional state: items 7, 8, 9 and 10; Mental state: items 3 and 4. Individual items within the CCQ are equally weighted. The total score is calculated by adding the scores of the ten items and dividing that number by ten (= number of items). The total CCQ score, and the score on each of the three domains, varies between 0 (very good health status) to 6 (extremely poor health status).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in MRC Dyspnea Scale</measure>
    <time_frame>Baseline and Months 3 and 6</time_frame>
    <description>The Medical Research Council (MRC) breathlessness (dyspnea) scale comprises five statements that describe almost the entire range of respiratory disability: 1 - Not troubled by breathlessness except on strenuous exercise; 2 - Short of breath when hurrying or walking up a slight hill; 3 - Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace; 4 - Stops for breath after walking about 100m or after a few minutes on level ground; 5 - Too breathless to leave the house, or breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Satisfaction with Roflumilast</measure>
    <time_frame>Baseline and Months 3 and 6</time_frame>
    <description>Is the perception of the participant according to the scale provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician's Satisfaction with Roflumilast</measure>
    <time_frame>Baseline and Months 3 and 6</time_frame>
    <description>Is the perception of Physician taking into consideration the effectiveness and the tolerability of the drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Forced Vital Capacity (FVC) at Month 3</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 3</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to treatment</measure>
    <time_frame>6 months</time_frame>
    <description>According to physician's judgment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse drug reactions (ADR)</measure>
    <time_frame>6 months</time_frame>
    <description>An ADR is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases or for the restoration, correction or modification of physiological function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concomitant administration of inhaled bronchodilators and corticosteroids</measure>
    <time_frame>6 months</time_frame>
    <description>Concomitant administration of inhaled bronchodilators and corticosteroids, either separately or in combination.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2577</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Roflumilast</arm_group_label>
    <description>Roflumilast will be administered according to the prescribing information of the approved label in Greece.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        COPD patients prescribed roflumilast in Greece.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Be diagnosed with COPD at stages 3 or 4 according to the Global Initiative for Chronic&#xD;
             Obstructive Lung Disease (GOLD) guidelines.&#xD;
&#xD;
          -  Have the clinical phenotype of chronic bronchitis with cough and sputum production&#xD;
             (with or without emphysema).&#xD;
&#xD;
          -  Already be receiving treatment for their disease (inhaled bronchodilators (long-acting&#xD;
             beta2-agonists (LABA), long-acting muscarinic antagonists (LAMA), short-acting&#xD;
             beta2-agonists (SABA), short-acting muscarinic antagonist (SAMA)), inhaled&#xD;
             corticosteroids (ICS), combination of inhaled bronchodilators and corticosteroids.&#xD;
&#xD;
          -  Be aged over 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AstraZeneca AstraZeneca</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>April 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</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>
  <!-- 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/NCT02187926
org study id: RO-2455-401-GR
nct id: NCT02187926
lead sponsor: 
has dmc: No
The purpose of this study was to examine the characteristics of patients selected for
      treatment with roflumilast and the effectiveness and safety of roflumilast in patients with
      severe or very severe COPD treated in Hospital and outpatient specialist ward settings in
      Greece.
The drug being observed in this study is called roflumilast. Roflumilast is used to treat
      people who have chronic obstructive pulmonary disease (COPD) associated with chronic
      bronchitis with a history of worsening symptoms. This study looked at side effects and the
      lung function of people who take roflumilast. The study enrolled 2577 patients who were
      already prescribed roflumilast as an add on to bronchiodilator treatment by their healthcare
      provider. This multi-centre trial was conducted in Greece. The overall time to participate in
      this study was up to 6 months. Participants were evaluated during routine appointments with
      their healthcare provider.
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6
time frame: Baseline and Month 6
description: FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
measure: Change From Baseline in Forced Vital Capacity (FVC) at Month 6
time frame: Baseline and Month 6
description: Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
measure: Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 6
time frame: Baseline and Month 6
description: The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.
measure: Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6
time frame: Baseline and Month 6
description: FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
measure: Percentage of Participants with Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
time frame: Month 3 and Month 6
description: A COPD exacerbation is an event characterised by a worsening in the patient's baseline dyspnoea, or cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management, and may be accompanied by increased wheeze, chest tightness, purulent sputum and symptoms of cold and/or fatigue.
measure: Percentage of Participants requiring Hospitalizations due to Exacerbations of COPD
time frame: Up to Month 6
measure: Change from Baseline in Clinical COPD Questionnaire (CCQ) Total Score
time frame: Baseline and Months 3 and 6
description: Quality of life will be evaluated using the Clinical COPD Questionnaire (CCQ) 10-item questionnaire. The questions in the CCQ are divided into three area's, or domains: Symptoms: items 1, 2, 5 and 6; Functional state: items 7, 8, 9 and 10; Mental state: items 3 and 4. Individual items within the CCQ are equally weighted. The total score is calculated by adding the scores of the ten items and dividing that number by ten (= number of items). The total CCQ score, and the score on each of the three domains, varies between 0 (very good health status) to 6 (extremely poor health status).
measure: Change from Baseline in MRC Dyspnea Scale
time frame: Baseline and Months 3 and 6
description: The Medical Research Council (MRC) breathlessness (dyspnea) scale comprises five statements that describe almost the entire range of respiratory disability: 1 - Not troubled by breathlessness except on strenuous exercise; 2 - Short of breath when hurrying or walking up a slight hill; 3 - Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace; 4 - Stops for breath after walking about 100m or after a few minutes on level ground; 5 - Too breathless to leave the house, or breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.
measure: Patient's Satisfaction with Roflumilast
time frame: Baseline and Months 3 and 6
description: Is the perception of the participant according to the scale provided.
measure: Physician's Satisfaction with Roflumilast
time frame: Baseline and Months 3 and 6
description: Is the perception of Physician taking into consideration the effectiveness and the tolerability of the drug.
measure: Change From Baseline in Forced Vital Capacity (FVC) at Month 3
time frame: Baseline and Month 3
description: Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
measure: Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 3
time frame: Baseline and Month 3
description: The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.
measure: Compliance to treatment
time frame: 6 months
description: According to physician's judgment
measure: Number of participants with adverse drug reactions (ADR)
time frame: 6 months
description: An ADR is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases or for the restoration, correction or modification of physiological function.
measure: Concomitant administration of inhaled bronchodilators and corticosteroids
time frame: 6 months
description: Concomitant administration of inhaled bronchodilators and corticosteroids, either separately or in combination.
arm group label: Roflumilast
description: Roflumilast will be administered according to the prescribing information of the approved label in Greece.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: AstraZeneca AstraZeneca
role: Study Director
affiliation: AstraZeneca
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive