<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/NCT03031769</url>
  </required_header>
  <id_info>
    <org_study_id>D5970R00006</org_study_id>
    <nct_id>NCT03031769</nct_id>
  </id_info>
  <brief_title>Symptoms and Physical Activity in COPD Patients in Europe</brief_title>
  <acronym>SPACE</acronym>
  <official_title>Symptoms and Physical Activity in COPD Patients in Europe</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>
      An observational, multinational, cross sectional study to describe 24-hs symptoms, physical&#xD;
      activity and their relationship in stable COPD patients in Europe&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a multi-centre, multi country, observational prospective cross sectional study&#xD;
      to determine the prevalence and severity of early morning, day and night-time symptoms and&#xD;
      physical activity patterns and to evaluate their correlation between each other and with&#xD;
      disease severity, adherence to respiratory medications, direct costs and PROs in patients&#xD;
      with stable COPD in Europe.&#xD;
&#xD;
      Approximately 2000 patients will be enrolled in convenient sites in several (9-12) selected&#xD;
      countries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2016</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients experiencing symptoms (previous 24 hours) and insufficient physical activity levels (previous month) despite being treated for COPD in real life setting.</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>• Relationship between 24 hours symptoms (Exact, EMSCI &amp; NiSCI questionnaires) and physical activity level (YPAS questionnaire) on day 1</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between 24 hours symptoms (Exact, EMSCI &amp; NiSCI questionnaires) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between 24 hours symptoms (Exact, EMSCI &amp; NiSCI questionnaires) and disease classification (By GOLD recommendation) on day 1</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between 24 hours symptoms (Exact, EMSCI &amp; NiSCI questionnaires) and level of dyspnea level (mMRC) on day 1</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between 24 hours symptoms (Exact, EMSCI &amp; NiSCI questionnaires) and HRQoL (CAT) on day 1</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between 24 hours symptoms (Exact, EMSCI &amp; NiSCI questionnaires) and history of exacerbations (By GOLD definition) in last 12 months</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between physical activity levels (YPAS questionnaire) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between physical activity levels (YPAS questionnaire) and disease classification (By GOLD recommendation) on day 1</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between physical activity levels (YPAS questionnaire) and level of dyspnea level (mMRC) on day 1</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between physical activity levels (YPAS questionnaire) and HRQoL (CAT) on day 1</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Relationship between physical activity levels (YPAS questionnaire) and history of exacerbations (By GOLD definition) in last 12 months</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">2176</enrollment>
  <condition>COPD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female ambulatory patients aged over 40 years diagnosed with stable COPD according&#xD;
        2013 GOLD criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients aged 40 years or older.&#xD;
&#xD;
          2. Patient has diagnosis of COPD for 1 year or more.&#xD;
&#xD;
          3. Patient has at least one spirometry with COPD criteria, fixed ratio &lt;0.70 post BD, in&#xD;
             previous 12 months&#xD;
&#xD;
          4. Patient is a current smoker or an ex-smoker with a smoking history of ≥ 10 pack-&#xD;
             years.&#xD;
&#xD;
          5. Stable patients, as stated in medical records or patient reports during visit, defined&#xD;
             as: without exacerbation treatment at study visit neither in the previous 2 months,&#xD;
             and without changes in maintenance COPD treatment regimen over the preceding 2 months&#xD;
             (avoid first consult patient)&#xD;
&#xD;
          6. Patients must be able and willing to read and comprehend written instructions, and&#xD;
             comprehend and complete the questionnaires required by the protocol&#xD;
&#xD;
          7. After full explanation, patients must have signed an informed consent document&#xD;
             indicating that they understand the purpose of and the procedures required for the&#xD;
             study and are willing to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has diagnosis of sleep apnea syndrome or other chronic respiratory disease&#xD;
             different from chronic obstructive diseases. (except for non-idiopathic pulmonary&#xD;
             fibrosis and ACOS, only if the main diagnosis is COPD)&#xD;
&#xD;
          2. An acute or chronic condition that, in the investigator's opinion, would limit the&#xD;
             patient's ability to complete questionnaires or participate in this study&#xD;
&#xD;
          3. Patient is participating in an ongoing clinical trial that might, in the&#xD;
             investigator's opinion, influence the assessment for SPACE study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florin D Mihaltan, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Institute Marius Nasta, Bucharest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03031769
org study id: D5970R00006
nct id: NCT03031769
lead sponsor: 
has dmc: No
An observational, multinational, cross sectional study to describe 24-hs symptoms, physical
      activity and their relationship in stable COPD patients in Europe
The study is a multi-centre, multi country, observational prospective cross sectional study
      to determine the prevalence and severity of early morning, day and night-time symptoms and
      physical activity patterns and to evaluate their correlation between each other and with
      disease severity, adherence to respiratory medications, direct costs and PROs in patients
      with stable COPD in Europe.

      Approximately 2000 patients will be enrolled in convenient sites in several (9-12) selected
      countries.
observational model: Cohort
time perspective: Cross-Sectional
measure: Proportion of patients experiencing symptoms (previous 24 hours) and insufficient physical activity levels (previous month) despite being treated for COPD in real life setting.
time frame: Day 1
measure: • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and physical activity level (YPAS questionnaire) on day 1
time frame: Day 1
measure: • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1
time frame: Day 1
measure: • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and disease classification (By GOLD recommendation) on day 1
time frame: Day 1
measure: • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and level of dyspnea level (mMRC) on day 1
time frame: Day 1
measure: • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and HRQoL (CAT) on day 1
time frame: Day 1
measure: • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and history of exacerbations (By GOLD definition) in last 12 months
time frame: Day 1
measure: • Relationship between physical activity levels (YPAS questionnaire) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1
time frame: Day 1
measure: • Relationship between physical activity levels (YPAS questionnaire) and disease classification (By GOLD recommendation) on day 1
time frame: Day 1
measure: • Relationship between physical activity levels (YPAS questionnaire) and level of dyspnea level (mMRC) on day 1
time frame: Day 1
measure: • Relationship between physical activity levels (YPAS questionnaire) and HRQoL (CAT) on day 1
time frame: Day 1
measure: • Relationship between physical activity levels (YPAS questionnaire) and history of exacerbations (By GOLD definition) in last 12 months
time frame: Day 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 130 Years
healthy volunteers: No
last name: Florin D Mihaltan, MD,PhD
role: Study Chair
affiliation: Institute Marius Nasta, Bucharest
facility: 
country: Romania
responsible party type: Sponsor