<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/NCT02990247</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2015/04</org_study_id>
    <nct_id>NCT02990247</nct_id>
  </id_info>
  <brief_title>Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study</brief_title>
  <acronym>AsthmaDom</acronym>
  <official_title>Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Asthma exacerbations account for a significant morbidity and disproportionate health care&#xD;
      costs. However, there is no currently available biomarker or lung function parameter that can&#xD;
      accurately predict the risk of future exacerbations. The current work aims at evaluating the&#xD;
      resting ventilatory flow by applying a new technique called anharmonic morphological analysis&#xD;
      of the respiratory signals (AMARS). We hypothesize that monitoring AMARS is potentially able&#xD;
      to detect an increased risk of asthma exacerbations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma exacerbations represent an acute or sub-acute worsening in symptoms and lung function&#xD;
      from the patient's usual status. Early detection of exacerbations is a major public health&#xD;
      issue. In clinic, management of asthma involves asthma control questionnaires and pulmonary&#xD;
      function tests (Forced Expiratory Volume (FEV1), Fractional exhaled nitric oxide or FeNO). At&#xD;
      home, the peak expiratory flow rate (PEFR) measured by the peak flow meter is an aid to&#xD;
      monitor asthma but its ability to predict asthma exacerbations remains controversial.&#xD;
      Anharmonic morphological analysis of the respiratory signals (AMARS) is a new&#xD;
      morpho-mathematic biomarker that produces objective and accurate measures of the shape of the&#xD;
      ventilatory flow. The current study aims at monitoring the resting spontaneous breathing at&#xD;
      home in asthmatics. Changes in AMARS may be a predictor of early symptoms of asthma&#xD;
      exacerbations. We will recruit 120 asthmatic patients. Patients will be given a portable&#xD;
      device for telemonitoring. Resting spontaneous breathing will be measured during 2-3 min in&#xD;
      the morning and in the evening, twice a week at least for 12 months. Three visits will be&#xD;
      scheduled in Clinical Investigation Center before (V1), after 6-month (V2) and 12-month (V3)&#xD;
      telemonitoring period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2016</start_date>
  <completion_date type="Actual">November 6, 2018</completion_date>
  <primary_completion_date type="Actual">November 6, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensibility parameters resting breath parameter to predict asthma exacerbation</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity of resting breath parameters to predict asthma exacerbation</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive predictive value of resting breath parameters to predict asthma exacerbation</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Negative predictive value of resting breath parameters to predict asthma exacerbation</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>FEV1</measure>
    <time_frame>Day 1</time_frame>
    <description>Volume that has been exhaled at the end of the first second of forced expiration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1</measure>
    <time_frame>6 months</time_frame>
    <description>Volume that has been exhaled at the end of the first second of forced expiration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1</measure>
    <time_frame>12 months</time_frame>
    <description>Volume that has been exhaled at the end of the first second of forced expiration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma exacerbation severity</measure>
    <time_frame>Day 1</time_frame>
    <description>The number of asthma exacerbations between Day 1 and month 12 will be quoted and defined according to the protocol (abnormal asthma symptoms increase requiring change in asthma medication). Each exacerbation will be quoted according to its severity as mild (requiring increased in inhaled beta2 agonists use for 7 days as assessed by item6 of the Asthma Control Questionnaire (ACQ)), moderate (requiring short course of oral steroid and/or antibiotics) or severe (i.e., requiring hospitalization).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma exacerbation severity</measure>
    <time_frame>12 months</time_frame>
    <description>The number of asthma exacerbations between Day 1 and month 12 will be quoted and defined according to the protocol (abnormal asthma symptoms increase requiring change in asthma medication). Each exacerbation will be quoted according to its severity as mild (requiring increased in inhaled beta2 agonists use for 7 days as assessed by item6 of the Asthma Control Questionnaire (ACQ)), moderate (requiring short course of oral steroid and/or antibiotics) or severe (i.e., requiring hospitalization).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma quality of life questionnaires</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma quality of life questionnaires</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma quality of life questionnaires</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control Test questionnaires</measure>
    <time_frame>day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control Test questionnaires</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control Test questionnaires</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Vital Capacity (FVC)</measure>
    <time_frame>day 1</time_frame>
    <description>Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FVC</measure>
    <time_frame>6 months</time_frame>
    <description>Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FVC</measure>
    <time_frame>12 months</time_frame>
    <description>Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1/FVC ratio</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1/FVC ratio</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1/FVC ratio</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Flow (FEF25-75%)</measure>
    <time_frame>Day 1</time_frame>
    <description>Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEF25-75%</measure>
    <time_frame>6 months</time_frame>
    <description>Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEF25-75%</measure>
    <time_frame>12 months</time_frame>
    <description>Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEF</measure>
    <time_frame>Day 1</time_frame>
    <description>Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEF</measure>
    <time_frame>6 months</time_frame>
    <description>Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEF</measure>
    <time_frame>12 months</time_frame>
    <description>Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>AMARS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>anharmonic morphological analysis of the respiratory signals (AMARS)</intervention_name>
    <arm_group_label>AMARS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female aged more than 18 yrs&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  diagnosis of asthma according to Global Initiative For Asthma (GINA) criteria&#xD;
&#xD;
          -  history of at least one moderate to severe exacerbation in the previous 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoker or former smoker (&gt; 10 packs-year)&#xD;
&#xD;
          -  concomitant asthma exacerbation (at V1)&#xD;
&#xD;
          -  prisoners&#xD;
&#xD;
          -  protected adults&#xD;
&#xD;
          -  no affiliation to the French Social Security System&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Berger, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grenoble University Hospital</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bordeaux University Hospital</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Exacerbations</keyword>
  <keyword>Telemonitoring</keyword>
  <keyword>Biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT02990247
org study id: CHUBX 2015/04
nct id: NCT02990247
lead sponsor: 
has dmc: Yes
Asthma exacerbations account for a significant morbidity and disproportionate health care
      costs. However, there is no currently available biomarker or lung function parameter that can
      accurately predict the risk of future exacerbations. The current work aims at evaluating the
      resting ventilatory flow by applying a new technique called anharmonic morphological analysis
      of the respiratory signals (AMARS). We hypothesize that monitoring AMARS is potentially able
      to detect an increased risk of asthma exacerbations.
Asthma exacerbations represent an acute or sub-acute worsening in symptoms and lung function
      from the patient's usual status. Early detection of exacerbations is a major public health
      issue. In clinic, management of asthma involves asthma control questionnaires and pulmonary
      function tests (Forced Expiratory Volume (FEV1), Fractional exhaled nitric oxide or FeNO). At
      home, the peak expiratory flow rate (PEFR) measured by the peak flow meter is an aid to
      monitor asthma but its ability to predict asthma exacerbations remains controversial.
      Anharmonic morphological analysis of the respiratory signals (AMARS) is a new
      morpho-mathematic biomarker that produces objective and accurate measures of the shape of the
      ventilatory flow. The current study aims at monitoring the resting spontaneous breathing at
      home in asthmatics. Changes in AMARS may be a predictor of early symptoms of asthma
      exacerbations. We will recruit 120 asthmatic patients. Patients will be given a portable
      device for telemonitoring. Resting spontaneous breathing will be measured during 2-3 min in
      the morning and in the evening, twice a week at least for 12 months. Three visits will be
      scheduled in Clinical Investigation Center before (V1), after 6-month (V2) and 12-month (V3)
      telemonitoring period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Sensibility parameters resting breath parameter to predict asthma exacerbation
time frame: 12 months
measure: Specificity of resting breath parameters to predict asthma exacerbation
time frame: 12 months
measure: Positive predictive value of resting breath parameters to predict asthma exacerbation
time frame: 12 months
measure: Negative predictive value of resting breath parameters to predict asthma exacerbation
time frame: 12 months
measure: FEV1
time frame: Day 1
description: Volume that has been exhaled at the end of the first second of forced expiration
measure: FEV1
time frame: 6 months
description: Volume that has been exhaled at the end of the first second of forced expiration
measure: FEV1
time frame: 12 months
description: Volume that has been exhaled at the end of the first second of forced expiration
measure: Asthma exacerbation severity
time frame: Day 1
description: The number of asthma exacerbations between Day 1 and month 12 will be quoted and defined according to the protocol (abnormal asthma symptoms increase requiring change in asthma medication). Each exacerbation will be quoted according to its severity as mild (requiring increased in inhaled beta2 agonists use for 7 days as assessed by item6 of the Asthma Control Questionnaire (ACQ)), moderate (requiring short course of oral steroid and/or antibiotics) or severe (i.e., requiring hospitalization).
measure: Asthma exacerbation severity
time frame: 12 months
description: The number of asthma exacerbations between Day 1 and month 12 will be quoted and defined according to the protocol (abnormal asthma symptoms increase requiring change in asthma medication). Each exacerbation will be quoted according to its severity as mild (requiring increased in inhaled beta2 agonists use for 7 days as assessed by item6 of the Asthma Control Questionnaire (ACQ)), moderate (requiring short course of oral steroid and/or antibiotics) or severe (i.e., requiring hospitalization).
measure: Asthma quality of life questionnaires
time frame: Day 1
measure: Asthma quality of life questionnaires
time frame: 6 months
measure: Asthma quality of life questionnaires
time frame: 12 months
measure: Asthma Control Test questionnaires
time frame: day 1
measure: Asthma Control Test questionnaires
time frame: 6 months
measure: Asthma Control Test questionnaires
time frame: 12 months
measure: Forced Vital Capacity (FVC)
time frame: day 1
description: Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
measure: FVC
time frame: 6 months
description: Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
measure: FVC
time frame: 12 months
description: Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
measure: FEV1/FVC ratio
time frame: Day 1
measure: FEV1/FVC ratio
time frame: 6 months
measure: FEV1/FVC ratio
time frame: 12 months
measure: Forced Expiratory Flow (FEF25-75%)
time frame: Day 1
description: Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled
measure: FEF25-75%
time frame: 6 months
description: Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled
measure: FEF25-75%
time frame: 12 months
description: Forced expiratory flow related to some portion of the FVC curve; modifiers refer to amount of FVC already exhaled
measure: PEF
time frame: Day 1
description: Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
measure: PEF
time frame: 6 months
description: Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
measure: PEF
time frame: 12 months
description: Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter
arm group label: AMARS
arm group type: Experimental
description: Evaluation the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS).
intervention type: Device
intervention name: anharmonic morphological analysis of the respiratory signals (AMARS)
arm group label: AMARS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Berger, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No