<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/NCT01700296</url>
  </required_header>
  <id_info>
    <org_study_id>34431</org_study_id>
    <nct_id>NCT01700296</nct_id>
  </id_info>
  <brief_title>COPD, Inflammation and Rehabilitation</brief_title>
  <official_title>COPD, Inflammation and Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with chronic obstructive pulmonary disease, also known as COPD or emphysema, is like&#xD;
      any other with a chronic illness not only affected by the physical discomfort the illness&#xD;
      gives. For COPD patients that is: accelerated loss of lung function, conditioning and&#xD;
      increased mortality: 25% of patients hospitalized with COPD exacerbation die 12 months later.&#xD;
&#xD;
      Patients are also characterized by various psychological factors such as reduced quality of&#xD;
      life, depression, etc.&#xD;
&#xD;
      Therefore, everywhere in the country newly diagnosed COPD patients are offered rehabilitation&#xD;
      in Region Zealand which consists of 10 weeks of classes 2 hours, 2 times a week with physical&#xD;
      exercise, smoking cessation, medication, nutrition education and psychosocial support and&#xD;
      patient education based on the National Health Service and international recommendations.&#xD;
&#xD;
      In the literature, the effect of rehabilitation on quality of life was measured using a&#xD;
      questionnaire (St. George Respiratory Questionnaire (SGRQ)), and the increase in function has&#xD;
      been measured using a walk test, but there are no studies which look at the effect on&#xD;
      inflammation lungs.&#xD;
&#xD;
      It is important for COPD patients is to prevent exacerbations of the disease, which sometimes&#xD;
      requires hospitalization and sometimes treated by their own doctor. It has been proven that&#xD;
      inflammation in the lungs is associated with disease severity and exacerbation frequency, and&#xD;
      therefore we would like to investigate whether both rehabilitation, close monitoring of&#xD;
      patients with time in the pulmonary clinic every 3 months, and instruction in&#xD;
      self-administration of medication (antibiotics and corticosteroids) have an effect on&#xD;
      especially inflammation in the lungs, number of exacerbations, mortality, lung function and&#xD;
      walking capacity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IL-8 in Sputum</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>IL-8 in serum IL-8 in the BAL fluid</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>walking distance</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>exacerbation frequency</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>&quot;Standard Care&quot;: finishing treatment for AECOPD in hospital and after hospital discharge to further control by the GP. In case of severe symptoms and / or airway obstruction (measured by FEV1) refer patients for follow-up in lung clinic. The subjects are recorded with the same subjective, clinical, paraclinical and invasive parameters as the &quot;Best care&quot; group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Best care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;Best Care&quot;: subjects are randomly assigned to the &quot;Best care&quot; regardless MRC class and severity of symptoms through:&#xD;
10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25)&#xD;
Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Best care</intervention_name>
    <description>&quot;Best Care&quot;: subjects are randomly assigned to the &quot;Best care&quot; regardless MRC class and severity of symptoms through:&#xD;
10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25)&#xD;
Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.</description>
    <arm_group_label>Best care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study includes consecutive patients over 18 years admitted to the Medical dept,&#xD;
             Næstved hospital with AECOPD (2 of 3 symptoms: increased breathlessness, sputum or&#xD;
             purulens thereof) on the basis of known COPD (post-bronchodilator FEV1 &lt;80% and&#xD;
             FEV1/FVC &lt;70% ; measured in stable phase, ie. earlier than 4 weeks after AECOPD).&#xD;
             Patients included during hospitalization for AECOPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients can not participate if they have asthma (post-bronchodilator FEV1 increased&#xD;
             by&gt; 15%), are pregnant, nursing, has known serious comorbidities (eg cancer, chronic&#xD;
             liver cirrhosis or hepatitis) or cannot give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Naestved Sygehus</name>
      <address>
        <city>Næstved</city>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>April 6, 2017</last_update_submitted>
  <last_update_submitted_qc>April 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Naestved Hospital</investigator_affiliation>
    <investigator_full_name>Mimi Christiansen</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</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/NCT01700296
org study id: 34431
nct id: NCT01700296
lead sponsor: 
has dmc: No
Patients with chronic obstructive pulmonary disease, also known as COPD or emphysema, is like
      any other with a chronic illness not only affected by the physical discomfort the illness
      gives. For COPD patients that is: accelerated loss of lung function, conditioning and
      increased mortality: 25% of patients hospitalized with COPD exacerbation die 12 months later.

      Patients are also characterized by various psychological factors such as reduced quality of
      life, depression, etc.

      Therefore, everywhere in the country newly diagnosed COPD patients are offered rehabilitation
      in Region Zealand which consists of 10 weeks of classes 2 hours, 2 times a week with physical
      exercise, smoking cessation, medication, nutrition education and psychosocial support and
      patient education based on the National Health Service and international recommendations.

      In the literature, the effect of rehabilitation on quality of life was measured using a
      questionnaire (St. George Respiratory Questionnaire (SGRQ)), and the increase in function has
      been measured using a walk test, but there are no studies which look at the effect on
      inflammation lungs.

      It is important for COPD patients is to prevent exacerbations of the disease, which sometimes
      requires hospitalization and sometimes treated by their own doctor. It has been proven that
      inflammation in the lungs is associated with disease severity and exacerbation frequency, and
      therefore we would like to investigate whether both rehabilitation, close monitoring of
      patients with time in the pulmonary clinic every 3 months, and instruction in
      self-administration of medication (antibiotics and corticosteroids) have an effect on
      especially inflammation in the lungs, number of exacerbations, mortality, lung function and
      walking capacity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: IL-8 in Sputum
time frame: 1 year
measure: IL-8 in serum IL-8 in the BAL fluid
time frame: 1 year
measure: walking distance
time frame: 1 year
measure: exacerbation frequency
time frame: 1 year
arm group label: Standard Care
arm group type: No Intervention
description: "Standard Care": finishing treatment for AECOPD in hospital and after hospital discharge to further control by the GP. In case of severe symptoms and / or airway obstruction (measured by FEV1) refer patients for follow-up in lung clinic. The subjects are recorded with the same subjective, clinical, paraclinical and invasive parameters as the "Best care" group
arm group label: Best care
arm group type: Experimental
description: "Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through:
10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25)
Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.
intervention type: Behavioral
intervention name: Best care
description: "Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through:
10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25)
Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.
arm group label: Best care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Naestved Hospital
investigator full name: Mimi Christiansen
investigator title: Medical Doctor
mesh term: Inflammation