<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/NCT01703416</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-RBG-ATC-2012/1</org_study_id>
    <nct_id>NCT01703416</nct_id>
  </id_info>
  <brief_title>Correlation Between Patient Perception and Findings on Clinical Examination in Chronic Obstructive Pulmonary Disease (COPD) Patients</brief_title>
  <acronym>RELIEF</acronym>
  <official_title>CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients Receiving Inhaled Combined Therapy (Corticosteroid/Long Acting ß2-agonist) - RELIEF Study</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>
      This is a multi-center, prospective, non-interventional study that aims to evaluate in daily&#xD;
      clinical practice the possible correlation between patient perception of the ability to&#xD;
      perform morning activities and the physician's assessment during a regular physical exam in&#xD;
      patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CorRELation between PatIent PErception of the Ability to Perform Morning Activities and&#xD;
      Findings on Clinical Examination in COPD Patients receiving inhaled combined therapy&#xD;
      (corticosteroid/long acting ß2-agonist) - RELIEF Study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 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 CDLM (Capacity of Daily Living during the Morning) questionnaire.</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of patient's general health status upon physical evaluation - visual scale</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)</measure>
    <time_frame>Day 0 (visit 1)</time_frame>
    <description>Descriptive statistics will be calculated for this outcome measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of daily walking steps (by using pedometers)</measure>
    <time_frame>up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient adherence to treatment (by using visual 5 point scale)</measure>
    <time_frame>up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of unscheduled visit (exacerbations, emergency visits)</measure>
    <time_frame>up to 3 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic Obstructive Pulmonary Disease (COPD) patients group C and D&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), group C and D according to&#xD;
             GOLD Guidelines, 2011&#xD;
&#xD;
          -  Receive inhaled combined therapy for COPD (inhaled corticosteroid / long acting&#xD;
             ß2-agonist); this treatment should have been initiated for at least one month before&#xD;
             entering the study&#xD;
&#xD;
          -  Current or past smokers, of at least 10 pack years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of exacerbation of COPD symptoms within the last month before visit 1,&#xD;
             inclusive.&#xD;
&#xD;
          -  History of asthma or allergic rhinitis.&#xD;
&#xD;
          -  History of lung carcinoma or any other respiratory condition that may limit the&#xD;
             airflow circulation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Varna</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>April 24, 2013</last_update_submitted>
  <last_update_submitted_qc>April 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>GOLD group C and D</keyword>
  <keyword>CDLM questionnaire</keyword>
  <keyword>visual scale - physician evaluation</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/NCT01703416
org study id: NIS-RBG-ATC-2012/1
nct id: NCT01703416
lead sponsor: 
has dmc: No
This is a multi-center, prospective, non-interventional study that aims to evaluate in daily
      clinical practice the possible correlation between patient perception of the ability to
      perform morning activities and the physician's assessment during a regular physical exam in
      patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.
CorRELation between PatIent PErception of the Ability to Perform Morning Activities and
      Findings on Clinical Examination in COPD Patients receiving inhaled combined therapy
      (corticosteroid/long acting ß2-agonist) - RELIEF Study
observational model: Cohort
time perspective: Prospective
measure: Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire.
time frame: Baseline and 3 months
measure: Change from baseline of patient's general health status upon physical evaluation - visual scale
time frame: Baseline and 3 months
measure: Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)
time frame: Day 0 (visit 1)
description: Descriptive statistics will be calculated for this outcome measure
measure: Number of daily walking steps (by using pedometers)
time frame: up to 3 months
measure: Patient adherence to treatment (by using visual 5 point scale)
time frame: up to 3 months
measure: Number of unscheduled visit (exacerbations, emergency visits)
time frame: up to 3 months
arm group label: 1
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Bulgaria
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive