<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/NCT01695265</url>
  </required_header>
  <id_info>
    <org_study_id>AC26392COPD</org_study_id>
    <nct_id>NCT01695265</nct_id>
  </id_info>
  <brief_title>Feel Breathe, Restriction Device Ventilatory Nasal (COPD)</brief_title>
  <acronym>BreatheCOPD</acronym>
  <official_title>Feel Breathe, Restriction Device Ventilatory Nasal (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cadiz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Regional Development Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cadiz</source>
  <oversight_info>
    <has_dmc>No</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>
      FEELBREATHE®, a nasal ventilatory restriction device, used during an exercise test in&#xD;
      treadmill produces changes on breathing efficiency in patients with Chronic Obstructive&#xD;
      Pulmonary Disease (COPD). 20 men with COPD with a forced expiratory volume in the first&#xD;
      second between 30% and 70% of its predicted value were selected. Then, a maximal incremental&#xD;
      cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters.&#xD;
      During the second day, each participant conducted two tests with 30 min of rest between them.&#xD;
      Exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at&#xD;
      50% of VO2peak. Each test was performed randomnly in two different conditions: 1) oronasal&#xD;
      breathing (ONB); and 2) nasal breathing through the FB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: A device called FeelBreahte (FB)® has been designed, developed and patented for&#xD;
      inspiratory muscle training in dynamic situations.&#xD;
&#xD;
      Objetive: To examine the effects of FB on lung ventilation, gas exchange and heart rate&#xD;
      during exercise in patients with COPD.&#xD;
&#xD;
      Methods: 20 men with COPD with a forced expiratory volume in the first second between 30% and&#xD;
      70% of its predicted value were selected. In the first visit to the laboratory, baseline&#xD;
      static maximum inspiratory pressure and spirometry were performed previous to the exercise.&#xD;
      Then, a maximal incremental cardiopulmonary exercise test was performed to determine&#xD;
      ventilatory and cardiac parameters. During the second day, each participant conducted two&#xD;
      tests with 30 min of rest between them. Exercise protocol was an identical walk on a&#xD;
      treadmill for 10 minutes at a constant rate at 50% of VO2peak. Each test was performed&#xD;
      randomnly in two different conditions: 1) oronasal breathing (ONB); and 2) nasal breathing&#xD;
      through the FB.&#xD;
&#xD;
      Results: Lung ventilation and gas exchange during exercise in COPD patients was modified&#xD;
      during exercise using FB. Our results showed a positive effects of FB vs ONB on dynamic&#xD;
      hyperinflation, an improved breathing pattern and breathing efficiency, higher expiratory and&#xD;
      inspiratory time and higher perceived effort. Despite these differences, blood oxygen&#xD;
      saturation percentage, oxygen uptake and heart rate showed similar response between both&#xD;
      conditions.&#xD;
&#xD;
      Conclusions: The new device FB used during exercise in COPD patients influenced ventilatory&#xD;
      responses to an efficiency breathing compared to oronasal mode.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD</measure>
    <time_frame>Subjects were assessed during 8 weeks</time_frame>
    <description>The investigators measure minute ventilation, peak oxygen uptake (VO2p), peak carbon dioxide production (VCO2p), breathing frequency (BF), ventilatory equivalent for carbon dioxide (CO2 Eq), ventilatory equivalent for oxygen (Eq O2), expiratory tidal volume (Vtexp), inspiratory tidal volume (Vtins), end-tidal carbon dioxide tension (PETCO2), end-tidal oxygen tension (PETO2), inspiratory time (T.in), ratio of inspiratory duration to total breath duration (ti/t), expiratory time (Tex), oxygen saturation measure by pulse-oximetry SpO2), heart rate (HR), duration of the test and dyspnea and leg fatigue measures by Borg scale. Each subject performed two identical submaximal exercises at 50% of VO2peak under different breathing conditions: 1) nasal breathing with FB and 2) oronasal breathing without FB. Incremental exercise tests were performed on a treadmill ergometer using a one minute step protocol to a symptom-limited maximum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximal Oxygen uptake</measure>
    <time_frame>Subjects were assessed during 8 weeks</time_frame>
    <description>Before experimental trials each subject performed an incremental protocol on a treadmill ergometer (MONARK, Hamburg, Germany) for the determination of gas exchange. The test was stopped upon volitional fatigue of the subject. Gas-exchange data were measured breath by breath using an Oxycon cardiopulmonary exercise system (Jaeger, Hoechberg, Germany).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum static inspiratory pressure (PImax)</measure>
    <time_frame>Subjects were assessed during 8 weeks</time_frame>
    <description>Inspiratory muscle testing was performed using a mouth pressure meter (Micro Medical Inc., Chatham, Kent, UK). The manufacturer states that the test-retest reliability of this device is ±3%. PImax was measured at residual volume and the best result from three inspiratory attempts was taken. Al least one minute was allowed between attempts to minimize the effects of muscle fatigue.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Exercie oronasal breathing (ONB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise protocol was walking on a treadmill for 10 minutes at a constant rate at 50% of VO2peak with oronasal breathing (ONB) (Without FeelBreathe device)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercie nasal breathing through the FB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise protocol was walking on a treadmill for 10 minutes at a constant rate at 50% of VO2peak with nasal restriction using FeelBreathe device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercie oronasal breathing (ONB)</intervention_name>
    <description>10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using oronasal breathing (ONB)</description>
    <arm_group_label>Exercie oronasal breathing (ONB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exercie nasal breathing through the FB</intervention_name>
    <description>Device: Feel Breathe, restriction device ventilatory nasal The Feel Breathe (FB) consisted of a small adhesive strip that is place across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacture's directions, while the placebo nasal, was placed over the nostrils of the subject, without interfering nasal breathing; thus, nasal airflow resistance was not increase. 10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using FeelBreathe device (FB)</description>
    <arm_group_label>Exercie nasal breathing through the FB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients diagnosed of Chronic Obstructive Pulmonary Disease (COPD) at least 6 months&#xD;
        before, with a forced expiratory volume in the first second (FEV1) between 70 and 30% of&#xD;
        predicted value&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffer other illness.&#xD;
&#xD;
          -  Unwillingness to complete the study requirements.&#xD;
&#xD;
          -  Cardiovascular diseases (resting electrocardiogram and during exercise).&#xD;
&#xD;
          -  Elevated resting blood pressure (&gt;130/85 mmHg). All inclusion and exclusion criteria&#xD;
             were assessed by a detailed medical history and, where noted, by specific&#xD;
             measurements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aurelio Arnedillo Muñoz, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Puerta del Mar Cádiz Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carmen Vaz Pardal, MD</last_name>
    <role>Study Director</role>
    <affiliation>Centro de Medicina del Deporte. Junta de Andalucía. Cádiz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose Lopez Chicharro, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Autonoma de Madrid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pelayo Arroyo García, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Cadiz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose Castro Piñero, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Cadiz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jorge dR Fernández Santos, PhD Student</last_name>
    <role>Study Chair</role>
    <affiliation>University of Cadiz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Davinia Vicente Campos, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad Complutense de Madrid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José L. González Montesinos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cadiz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julio Conde Caveda, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Cadiz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jesús G Ponce González, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Cadiz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Andaluz Medicina del Deporte</name>
      <address>
        <city>San Fernándo</city>
        <state>Cádiz</state>
        <zip>11100</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>May 31, 2018</last_update_submitted>
  <last_update_submitted_qc>May 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cadiz</investigator_affiliation>
    <investigator_full_name>Jose Luis Gonzalez Montesinos</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Airflow Obstruction</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>
    <ipd_description>All researchers included in this study could access to the database</ipd_description>
  </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/NCT01695265
org study id: AC26392COPD
nct id: NCT01695265
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
FEELBREATHE®, a nasal ventilatory restriction device, used during an exercise test in
      treadmill produces changes on breathing efficiency in patients with Chronic Obstructive
      Pulmonary Disease (COPD). 20 men with COPD with a forced expiratory volume in the first
      second between 30% and 70% of its predicted value were selected. Then, a maximal incremental
      cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters.
      During the second day, each participant conducted two tests with 30 min of rest between them.
      Exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at
      50% of VO2peak. Each test was performed randomnly in two different conditions: 1) oronasal
      breathing (ONB); and 2) nasal breathing through the FB.
Rationale: A device called FeelBreahte (FB)® has been designed, developed and patented for
      inspiratory muscle training in dynamic situations.

      Objetive: To examine the effects of FB on lung ventilation, gas exchange and heart rate
      during exercise in patients with COPD.

      Methods: 20 men with COPD with a forced expiratory volume in the first second between 30% and
      70% of its predicted value were selected. In the first visit to the laboratory, baseline
      static maximum inspiratory pressure and spirometry were performed previous to the exercise.
      Then, a maximal incremental cardiopulmonary exercise test was performed to determine
      ventilatory and cardiac parameters. During the second day, each participant conducted two
      tests with 30 min of rest between them. Exercise protocol was an identical walk on a
      treadmill for 10 minutes at a constant rate at 50% of VO2peak. Each test was performed
      randomnly in two different conditions: 1) oronasal breathing (ONB); and 2) nasal breathing
      through the FB.

      Results: Lung ventilation and gas exchange during exercise in COPD patients was modified
      during exercise using FB. Our results showed a positive effects of FB vs ONB on dynamic
      hyperinflation, an improved breathing pattern and breathing efficiency, higher expiratory and
      inspiratory time and higher perceived effort. Despite these differences, blood oxygen
      saturation percentage, oxygen uptake and heart rate showed similar response between both
      conditions.

      Conclusions: The new device FB used during exercise in COPD patients influenced ventilatory
      responses to an efficiency breathing compared to oronasal mode.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD
time frame: Subjects were assessed during 8 weeks
description: The investigators measure minute ventilation, peak oxygen uptake (VO2p), peak carbon dioxide production (VCO2p), breathing frequency (BF), ventilatory equivalent for carbon dioxide (CO2 Eq), ventilatory equivalent for oxygen (Eq O2), expiratory tidal volume (Vtexp), inspiratory tidal volume (Vtins), end-tidal carbon dioxide tension (PETCO2), end-tidal oxygen tension (PETO2), inspiratory time (T.in), ratio of inspiratory duration to total breath duration (ti/t), expiratory time (Tex), oxygen saturation measure by pulse-oximetry SpO2), heart rate (HR), duration of the test and dyspnea and leg fatigue measures by Borg scale. Each subject performed two identical submaximal exercises at 50% of VO2peak under different breathing conditions: 1) nasal breathing with FB and 2) oronasal breathing without FB. Incremental exercise tests were performed on a treadmill ergometer using a one minute step protocol to a symptom-limited maximum.
measure: Maximal Oxygen uptake
time frame: Subjects were assessed during 8 weeks
description: Before experimental trials each subject performed an incremental protocol on a treadmill ergometer (MONARK, Hamburg, Germany) for the determination of gas exchange. The test was stopped upon volitional fatigue of the subject. Gas-exchange data were measured breath by breath using an Oxycon cardiopulmonary exercise system (Jaeger, Hoechberg, Germany).
measure: Maximum static inspiratory pressure (PImax)
time frame: Subjects were assessed during 8 weeks
description: Inspiratory muscle testing was performed using a mouth pressure meter (Micro Medical Inc., Chatham, Kent, UK). The manufacturer states that the test-retest reliability of this device is ±3%. PImax was measured at residual volume and the best result from three inspiratory attempts was taken. Al least one minute was allowed between attempts to minimize the effects of muscle fatigue.
arm group label: Exercie oronasal breathing (ONB)
arm group type: Experimental
description: Exercise protocol was walking on a treadmill for 10 minutes at a constant rate at 50% of VO2peak with oronasal breathing (ONB) (Without FeelBreathe device)
arm group label: Exercie nasal breathing through the FB
arm group type: Experimental
description: Exercise protocol was walking on a treadmill for 10 minutes at a constant rate at 50% of VO2peak with nasal restriction using FeelBreathe device.
intervention type: Other
intervention name: Exercie oronasal breathing (ONB)
description: 10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using oronasal breathing (ONB)
arm group label: Exercie oronasal breathing (ONB)
intervention type: Device
intervention name: Exercie nasal breathing through the FB
description: Device: Feel Breathe, restriction device ventilatory nasal The Feel Breathe (FB) consisted of a small adhesive strip that is place across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacture's directions, while the placebo nasal, was placed over the nostrils of the subject, without interfering nasal breathing; thus, nasal airflow resistance was not increase. 10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using FeelBreathe device (FB)
arm group label: Exercie nasal breathing through the FB
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Aurelio Arnedillo Muñoz, PhD
role: Study Director
affiliation: Hospital Puerta del Mar Cádiz Spain
last name: Carmen Vaz Pardal, MD
role: Study Director
affiliation: Centro de Medicina del Deporte. Junta de Andalucía. Cádiz
last name: Jose Lopez Chicharro, PhD
role: Study Director
affiliation: Universidad Autonoma de Madrid
last name: Pelayo Arroyo García, PhD
role: Study Chair
affiliation: University of Cadiz
last name: Jose Castro Piñero, PhD
role: Study Director
affiliation: University of Cadiz
last name: Jorge dR Fernández Santos, PhD Student
role: Study Chair
affiliation: University of Cadiz
last name: Davinia Vicente Campos, PhD
role: Study Chair
affiliation: Universidad Complutense de Madrid
last name: José L. González Montesinos, PhD
role: Principal Investigator
affiliation: University of Cadiz
last name: Julio Conde Caveda, PhD
role: Study Chair
affiliation: University of Cadiz
last name: Jesús G Ponce González, PhD
role: Study Director
affiliation: University of Cadiz
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Cadiz
investigator full name: Jose Luis Gonzalez Montesinos
investigator title: Principal Investigator
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No
ipd description: All researchers included in this study could access to the database