<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/NCT02209974</url>
  </required_header>
  <id_info>
    <org_study_id>IC-COPD-2014</org_study_id>
    <nct_id>NCT02209974</nct_id>
  </id_info>
  <brief_title>Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD</brief_title>
  <official_title>Inhaled Corticosteroids do Not Modify the Systemic Inflammation Induced by Exercise in Patients With Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Son Llatzer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sociedad Española de Neumología y Cirugía Torácica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Son Espases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Spanish Research Center for Respiratory Diseases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundació d'investigació Sanitària de les Illes Balears</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Son Llatzer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic&#xD;
      inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is&#xD;
      controversial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical exercise produces a systemic inflammatory response, both in the healthy individual&#xD;
      and in the COPD patient (Rabinovitch et al ERJ 2003; van Helvoort et al Respir Med 2005;&#xD;
      Davidson WJ et al. J Appl Physiol). Nevertheless, although it has been described that some of&#xD;
      the systemic biomarkers related with COPD (Protein C-Reactive (PCR), interleukin [IL]-8) are&#xD;
      associated with a lower tolerance to exercise in COPD patients (García-Río et al. Respir Res&#xD;
      2010), the role of IC on systemic inflammation triggered by exercise in COPD patients remains&#xD;
      unknown.&#xD;
&#xD;
      This study explores the hypothesis that the inflammatory response induced by exercise in COPD&#xD;
      patients could be with IC treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2004</start_date>
  <completion_date type="Actual">November 2009</completion_date>
  <primary_completion_date type="Actual">November 2009</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in response to exercise between healthy and COPD patients</measure>
    <time_frame>1 month</time_frame>
    <description>16 COPD patients were compared with 7 healthy, sedentary and nonsmoker controls. All of them carried out an incremental cycle exercise test (ICET) limited by symptoms.&#xD;
1 month later, ICET was repeated only by COPD patients.&#xD;
Venous blood samples were obtained at rest and during peak exercise.&#xD;
Anthropometric, functional and response characteristics to exercise:&#xD;
Age, years&#xD;
BMI, m2.kg-1&#xD;
FEV1/FVC, %&#xD;
FEV1, % reference&#xD;
Peak charge, watts&#xD;
VO2 peak, mL.min-1&#xD;
Respiratory quotient&#xD;
VE peak, L.min-1&#xD;
Fc peak, lpm&#xD;
Lactic acid peak, mmol.L-1&#xD;
SaO2 basal, %&#xD;
SaO2 peak, %</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Inhaled Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Inhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inhaled corticosteroids (Fluticasone, 0.5 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhaled corticosteroids administered to the other half (n=8) of COPD patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone</intervention_name>
    <description>Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.</description>
    <arm_group_label>Inhaled corticosteroids (Fluticasone, 0.5 mg)</arm_group_label>
    <other_name>Inhaled Corticosteroids</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inhaled Placebo</intervention_name>
    <arm_group_label>Inhaled Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ex-smokers (&gt; 10 packets-year) with moderate-severe COPD patients&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>58 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonia Fuster, PhD Medicine</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Son Llatzer</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaume Sauleda, PhD Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Son Espases</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catalina Balaguer, Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Son Espases</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bernardí Barceló, PhD Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Son Espases</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angel Rios, Nursing</last_name>
    <role>Study Chair</role>
    <affiliation>FISIB Fundació Investigació de les Illes Balears</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amanda Iglesias, Biology</last_name>
    <role>Study Chair</role>
    <affiliation>FISIB Fundació Investigació de les Illes Balears</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aina Noguera, Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Son Espases</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bernat Togores, Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Son Espases</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alvar Agustí, PhD Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>IDIBAPS Hospital Clínic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ernest Sala-Llinàs, PhD Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Son Espases</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Son Llatzer</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Baleares</state>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Son Llatzer</investigator_affiliation>
    <investigator_full_name>Antonia Fuster</investigator_full_name>
    <investigator_title>Medicine PhD</investigator_title>
  </responsible_party>
  <keyword>emphysema</keyword>
  <keyword>CRP</keyword>
  <keyword>interleukin-8</keyword>
  <keyword>dynamic hyperinflation</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>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
  </intervention_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/NCT02209974
org study id: IC-COPD-2014
nct id: NCT02209974
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic
      inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is
      controversial.
Physical exercise produces a systemic inflammatory response, both in the healthy individual
      and in the COPD patient (Rabinovitch et al ERJ 2003; van Helvoort et al Respir Med 2005;
      Davidson WJ et al. J Appl Physiol). Nevertheless, although it has been described that some of
      the systemic biomarkers related with COPD (Protein C-Reactive (PCR), interleukin [IL]-8) are
      associated with a lower tolerance to exercise in COPD patients (García-Río et al. Respir Res
      2010), the role of IC on systemic inflammation triggered by exercise in COPD patients remains
      unknown.

      This study explores the hypothesis that the inflammatory response induced by exercise in COPD
      patients could be with IC treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Differences in response to exercise between healthy and COPD patients
time frame: 1 month
description: 16 COPD patients were compared with 7 healthy, sedentary and nonsmoker controls. All of them carried out an incremental cycle exercise test (ICET) limited by symptoms.
1 month later, ICET was repeated only by COPD patients.
Venous blood samples were obtained at rest and during peak exercise.
Anthropometric, functional and response characteristics to exercise:
Age, years
BMI, m2.kg-1
FEV1/FVC, %
FEV1, % reference
Peak charge, watts
VO2 peak, mL.min-1
Respiratory quotient
VE peak, L.min-1
Fc peak, lpm
Lactic acid peak, mmol.L-1
SaO2 basal, %
SaO2 peak, %
arm group label: Inhaled Placebo
arm group type: Placebo Comparator
description: Inhaled placebo administered to healthy (n=7) and to a half (n=8) of COPD patients
arm group label: Inhaled corticosteroids (Fluticasone, 0.5 mg)
arm group type: Experimental
description: Inhaled corticosteroids administered to the other half (n=8) of COPD patients
intervention type: Drug
intervention name: Fluticasone
description: Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.
arm group label: Inhaled corticosteroids (Fluticasone, 0.5 mg)
other name: Inhaled Corticosteroids
intervention type: Drug
intervention name: Inhaled Placebo
arm group label: Inhaled Placebo
criteria: 
gender: Male
minimum age: 58 Years
maximum age: 72 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Antonia Fuster, PhD Medicine
role: Principal Investigator
affiliation: Hospital Son Llatzer
last name: Jaume Sauleda, PhD Medicine
role: Study Chair
affiliation: Hospital Son Espases
last name: Catalina Balaguer, Medicine
role: Study Chair
affiliation: Hospital Son Espases
last name: Bernardí Barceló, PhD Medicine
role: Study Chair
affiliation: Hospital Son Espases
last name: Angel Rios, Nursing
role: Study Chair
affiliation: FISIB Fundació Investigació de les Illes Balears
last name: Amanda Iglesias, Biology
role: Study Chair
affiliation: FISIB Fundació Investigació de les Illes Balears
last name: Aina Noguera, Medicine
role: Study Chair
affiliation: Hospital Son Espases
last name: Bernat Togores, Medicine
role: Study Chair
affiliation: Hospital Son Espases
last name: Alvar Agustí, PhD Medicine
role: Study Chair
affiliation: IDIBAPS Hospital Clínic
last name: Ernest Sala-Llinàs, PhD Medicine
role: Study Chair
affiliation: Hospital Son Espases
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Son Llatzer
investigator full name: Antonia Fuster
investigator title: Medicine PhD
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Inflammation
mesh term: Fluticasone