<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/NCT03031093</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 57946516.0.0000.5537</org_study_id>
    <nct_id>NCT03031093</nct_id>
  </id_info>
  <brief_title>Aerosol Therapy in Obese COPD Patients.</brief_title>
  <official_title>Aerosol Therapy With High Flow Nasal Cannula (HFNC) in Obese COPD Patients. Aerosol Deposition Pattern and Predictive Values.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio Grande do Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study has the objective to clarify the factors that directly influence the effectiveness&#xD;
      of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease&#xD;
      (COPD) and suggest the use of High Flow Nasal Cannula (HFNC) during their inhalation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has the objective to clarify the factors that directly influence the effectiveness&#xD;
      of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease&#xD;
      (COPD) and then formulate specific strategies to control the evolution of this disease. The&#xD;
      suggested strategy in order to implement the aerosol therapy is the use of High Flow Nasal&#xD;
      Cannula (HFNC) during these patient´s inhalation therapy.&#xD;
&#xD;
      It will consist in a cross-over clinical trial. The population will be composed by volunteers&#xD;
      of both genders, aged between 45-70 years old. Four distinct groups will be formed: obese&#xD;
      participants without copd; obese participants with copd; non obese participants without copd;&#xD;
      non-obese participants with copd.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2017</start_date>
  <completion_date type="Actual">May 5, 2018</completion_date>
  <primary_completion_date type="Actual">April 3, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pattern of aerosol lung deposition.</measure>
    <time_frame>during the following 25 minutes post inhalation protocol</time_frame>
    <description>The pattern of aerosol lung deposition will be compared between obese and non obese participants (with and without COPD) as well as between inhalation with HFNC and without HFNC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of pulmonary function after bronchodilators administration. (with and without HFNC)</measure>
    <time_frame>Change from Baseline Pulmonary Function at 5 minutes after scintigraphy.</time_frame>
    <description>pulmonary function will be evaluated previously to the inhalation protocol. After the inhalation protocol, this measurement will be assessed again in order to check the effect of bronchodilator drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper airways anatomical variables CT scans</measure>
    <time_frame>first day of study</time_frame>
    <description>Upper airways anatomical variables will be measured by CT scans.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mallampati Score</measure>
    <time_frame>first day of study</time_frame>
    <description>Mallampati Score (from 1 to 4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>first day of study</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Mass</measure>
    <time_frame>first day of study</time_frame>
    <description>Muscle Mass percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat</measure>
    <time_frame>first day of study</time_frame>
    <description>Body fat percentage</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease Moderate</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Healthy, non obese + HFNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy, non obese participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy, non obese</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy, non obese participants will perform the following inhalation protocol: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD, non obese + HFNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>non obese COPD participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD, non obese</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>non obese COPD participants will perform the following inhalation protocol: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy, obese + HFNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy obese participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy, obese</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy obese participants will perform the following inhalation protocol: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD, obese + HFNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Obese COPD participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD, obese</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Obese COPD participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>inhalation protocol</intervention_name>
    <description>technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution</description>
    <arm_group_label>COPD, non obese</arm_group_label>
    <arm_group_label>COPD, non obese + HFNC</arm_group_label>
    <arm_group_label>COPD, obese</arm_group_label>
    <arm_group_label>COPD, obese + HFNC</arm_group_label>
    <arm_group_label>Healthy, non obese</arm_group_label>
    <arm_group_label>Healthy, non obese + HFNC</arm_group_label>
    <arm_group_label>healthy, obese</arm_group_label>
    <arm_group_label>healthy, obese + HFNC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High Flow Nasal Cannula</intervention_name>
    <description>aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula will deliver the aerosol at a 30L/min flow of oxigen.</description>
    <arm_group_label>COPD, non obese + HFNC</arm_group_label>
    <arm_group_label>COPD, obese + HFNC</arm_group_label>
    <arm_group_label>Healthy, non obese + HFNC</arm_group_label>
    <arm_group_label>healthy, obese + HFNC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        HEALTHY, non obese&#xD;
&#xD;
          -  no history of respiratory disease&#xD;
&#xD;
          -  non smokers&#xD;
&#xD;
          -  self declared sedentary&#xD;
&#xD;
          -  Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted&#xD;
&#xD;
          -  Forced Vital capacity (FVC) equal or higher than 80% of predicted;&#xD;
&#xD;
          -  FEV1/FVC higher than 70% of predicted.&#xD;
&#xD;
          -  BMI lower than 30 kg/m2&#xD;
&#xD;
        HEALTHY, obese&#xD;
&#xD;
          -  no history of respiratory disease&#xD;
&#xD;
          -  non smokers&#xD;
&#xD;
          -  self declared sedentary&#xD;
&#xD;
          -  Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted&#xD;
&#xD;
          -  Forced Vital capacity (FVC) equal or higher than 80% of predicted&#xD;
&#xD;
          -  FEV1/FVC higher than 70% of predicted.&#xD;
&#xD;
          -  BMI equal or higher than 30 kg/m2&#xD;
&#xD;
        COPD participants, non obese&#xD;
&#xD;
          -  ex smokers&#xD;
&#xD;
          -  clinical stability (six previous weeks)&#xD;
&#xD;
          -  FEV1 lower than 80% of predicted.&#xD;
&#xD;
          -  FEV1/FVC lower than 70 % post bronchodilator.&#xD;
&#xD;
          -  No cardiopulmonary diseases (self declared)&#xD;
&#xD;
          -  BMI lower than 30 kg/m2&#xD;
&#xD;
        COPD participants, obese&#xD;
&#xD;
          -  ex smokers&#xD;
&#xD;
          -  clinical stability (six previous weeks)&#xD;
&#xD;
          -  FEV1 lower than 80% of predicted.&#xD;
&#xD;
          -  FEV1/FVC lower than 70 % post bronchodilator.&#xD;
&#xD;
          -  No cardiopulmonary diseases (self declared)&#xD;
&#xD;
          -  BMI equal or higher than 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficulty to understand verbal commands&#xD;
&#xD;
          -  exacerbations during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Armele Dornelas de Andrade, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Federal de Pernambuco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de Pernambuco</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <zip>50670-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Taciano Dias de Souza Rocha</investigator_full_name>
    <investigator_title>Master in Physiotherapy</investigator_title>
  </responsible_party>
  <keyword>aerosol therapy</keyword>
  <keyword>pulmonary scintigraphy</keyword>
  <keyword>upper airways anatomy</keyword>
  <keyword>High Flow Nasal Cannula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03031093
org study id: CAAE: 57946516.0.0000.5537
nct id: NCT03031093
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study has the objective to clarify the factors that directly influence the effectiveness
      of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease
      (COPD) and suggest the use of High Flow Nasal Cannula (HFNC) during their inhalation therapy.
This study has the objective to clarify the factors that directly influence the effectiveness
      of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease
      (COPD) and then formulate specific strategies to control the evolution of this disease. The
      suggested strategy in order to implement the aerosol therapy is the use of High Flow Nasal
      Cannula (HFNC) during these patient´s inhalation therapy.

      It will consist in a cross-over clinical trial. The population will be composed by volunteers
      of both genders, aged between 45-70 years old. Four distinct groups will be formed: obese
      participants without copd; obese participants with copd; non obese participants without copd;
      non-obese participants with copd.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Pattern of aerosol lung deposition.
time frame: during the following 25 minutes post inhalation protocol
description: The pattern of aerosol lung deposition will be compared between obese and non obese participants (with and without COPD) as well as between inhalation with HFNC and without HFNC
measure: Change of pulmonary function after bronchodilators administration. (with and without HFNC)
time frame: Change from Baseline Pulmonary Function at 5 minutes after scintigraphy.
description: pulmonary function will be evaluated previously to the inhalation protocol. After the inhalation protocol, this measurement will be assessed again in order to check the effect of bronchodilator drug.
measure: Upper airways anatomical variables CT scans
time frame: first day of study
description: Upper airways anatomical variables will be measured by CT scans.
measure: Mallampati Score
time frame: first day of study
description: Mallampati Score (from 1 to 4)
measure: BMI
time frame: first day of study
description: Body mass index
measure: Muscle Mass
time frame: first day of study
description: Muscle Mass percentage
measure: Body fat
time frame: first day of study
description: Body fat percentage
arm group label: Healthy, non obese + HFNC
arm group type: Experimental
description: Healthy, non obese participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).
arm group label: Healthy, non obese
arm group type: Active Comparator
description: Healthy, non obese participants will perform the following inhalation protocol: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).
arm group label: COPD, non obese + HFNC
arm group type: Experimental
description: non obese COPD participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).
arm group label: COPD, non obese
arm group type: Active Comparator
description: non obese COPD participants will perform the following inhalation protocol: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).
arm group label: healthy, obese + HFNC
arm group type: Experimental
description: Healthy obese participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).
arm group label: healthy, obese
arm group type: Active Comparator
description: Healthy obese participants will perform the following inhalation protocol: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).
arm group label: COPD, obese + HFNC
arm group type: Experimental
description: Obese COPD participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).
arm group label: COPD, obese
arm group type: Active Comparator
description: Obese COPD participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).
intervention type: Radiation
intervention name: inhalation protocol
description: technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution
arm group label: COPD, non obese
arm group label: COPD, non obese + HFNC
arm group label: COPD, obese
arm group label: COPD, obese + HFNC
arm group label: Healthy, non obese
arm group label: Healthy, non obese + HFNC
arm group label: healthy, obese
arm group label: healthy, obese + HFNC
intervention type: Device
intervention name: High Flow Nasal Cannula
description: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula will deliver the aerosol at a 30L/min flow of oxigen.
arm group label: COPD, non obese + HFNC
arm group label: COPD, obese + HFNC
arm group label: Healthy, non obese + HFNC
arm group label: healthy, obese + HFNC
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Armele Dornelas de Andrade, PhD
role: Study Director
affiliation: Universidade Federal de Pernambuco
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Taciano Dias de Souza Rocha
investigator title: Master in Physiotherapy
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No