<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/NCT04447664</url>
  </required_header>
  <id_info>
    <org_study_id>TMED_SPIRO_001</org_study_id>
    <nct_id>NCT04447664</nct_id>
  </id_info>
  <brief_title>Telemonitoring of Lung Function by Spirometry</brief_title>
  <official_title>Telespirometry: Home Monitoring of Asthmatic Patients With Spirometer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szeged University</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>
      Asthma is the most common respiratory disorder in children that causes breathing problems.&#xD;
      The patients may have respiratory symptoms such as cough, wheeze, or short of breath. Asthma&#xD;
      can be mild or severe when daily activities become compromised. Generally, by application of&#xD;
      proper treatment, asthma symptoms can be well controlled. However, the exacerbation of the&#xD;
      disease often leads to acute respiratory adverse events that require hospitalization and&#xD;
      school absenteeism.&#xD;
&#xD;
      In this study, we plan the remote monitoring of lung function parameters in asthmatic&#xD;
      children (under 18 years of age). We hypothesize that the daily home monitoring of&#xD;
      respiratory indices will predict the occurrence of exacerbation and the hospitalization can&#xD;
      be lowered.&#xD;
&#xD;
      Asthmatic children arriving for the regular examinations to the Department of Pediatrics and&#xD;
      Pediatric Health Care Center of the University of Szeged will be involved. The patients are&#xD;
      randomly divided into two treatment groups, telemonitoring and control.&#xD;
&#xD;
      For both groups, general patient characteristics will be recorded, and lung function&#xD;
      parameters will be measured with a clinical spirometer.&#xD;
&#xD;
      Patients in the telemedicine group receive the home mobile controlled spirometer and trained&#xD;
      by a pediatric pulmonologist for home examination. The spirometers are handed for 12 months,&#xD;
      and children are asked to perform measurements minimum 4 times per week (at least one day a&#xD;
      week in the morning and in the evening). In the case of asthma attacks, more frequent&#xD;
      measurements repeated several times a day are required. Children in the telemedicine group&#xD;
      complete the Asthma Control Test (ACT) after each measurement, which provides a numerical&#xD;
      score related to the severity of asthma symptoms. Lung function parameters measured by&#xD;
      children and the ACT results are automatically uploaded to a clinical server where the&#xD;
      pulmonologists and built-in algorithms are monitoring the quality of the data. In case of&#xD;
      deterioration of the lung function parameters, the patients are called for a personal visit&#xD;
      and their treatment can be revised.&#xD;
&#xD;
      Every three months, members of both groups come to the outpatient clinic for a personal&#xD;
      visit, where the same examinations are performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is the most common respiratory disorder in children characterized by periodic airway&#xD;
      obstruction, bronchial hyper-responsiveness, and airway inflammation. The symptoms of asthma&#xD;
      may include cough, wheeze, or bronchoconstriction with airflow limitation. The severity of&#xD;
      asthma may vary from mild to severe. Mild asthma is associated with rear events of short of&#xD;
      breath. However, the exacerbation of the disease often leads to acute respiratory adverse&#xD;
      events with severe hypoxia that requires hospitalization. The hospital care involves travel&#xD;
      costs for the children and parents, school and work absenteeism.&#xD;
&#xD;
      The primary objective of the study is to investigate whether the annual occurrence of asthma&#xD;
      exacerbation can be decreased by the use of the telespirometry system. Another objective is&#xD;
      to determine which lung function parameters are best to predict asthma exacerbation.&#xD;
&#xD;
      To address these aims we plan to involve two groups (telemonitoring and control) of asthmatic&#xD;
      children with GINA 2-5 stage under 18 years of age. Poor general condition, any disease which&#xD;
      endangers the health of the volunteer or contraindicates the study and lack of parental&#xD;
      consent are defined as the exclusion criteria.&#xD;
&#xD;
      The lung function in the children in both groups will be monitored by conventional&#xD;
      spirometric assessment performed at the Department of Pediatrics and Pediatric Health Care&#xD;
      Center of the University of Szeged. After each lung function assessments children will be&#xD;
      asked to fill the Asthma Control Test (ACT).&#xD;
&#xD;
      Patients in the telemedicine group receive the home mobile controlled spirometer and trained&#xD;
      by a pediatric pulmonologist for home examination. The spirometers are handed for 12 months,&#xD;
      and children are asked to perform measurements minimum 4 times per week (at least one day a&#xD;
      week in the morning and in the evening). In the case of asthma exacerbation, more frequent&#xD;
      measurements repeated several times a day are required. Children in the telemedicine group&#xD;
      complete the ACT after each measurement, which provides a numerical score related to the&#xD;
      severity of asthma symptoms. Lung function parameters measured by children and the ACT test&#xD;
      results are automatically uploaded to a clinical server where the pulmonologists and built-in&#xD;
      algorithms are monitoring the quality of the data. In case of deterioration of the lung&#xD;
      function parameters, the patients are called for a personal visit and their treatment can be&#xD;
      revised.&#xD;
&#xD;
      Every three months, members of both groups come to the outpatient clinic for a personal&#xD;
      visit, where the same examinations are performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 30, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of asthma exacerbations per year</measure>
    <time_frame>12 months</time_frame>
    <description>Change of the incidence of asthma exacerbations per year using telespirometry system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>expiratory Forced Vital Capacity (FVC), the maximum amount of air that can forcibly be blown out after full inspiration</measure>
    <time_frame>12 months</time_frame>
    <description>Lung function parameters to predict asthma exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in one second (FEV1), is the volume of air that can forcibly be blown out in first 1 second after full inspiration</measure>
    <time_frame>12 months</time_frame>
    <description>Lung function parameters to predict asthma exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1/FVC ratio (FEV1%)</measure>
    <time_frame>12 months</time_frame>
    <description>Lung function parameters to predict asthma exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow (PEF), peak expiratory flow rate during expiration</measure>
    <time_frame>12 months</time_frame>
    <description>Lung function parameters to predict asthma exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Flow at 25-75% of FVC (FEF25-75%), mean of forced expiratory flow over the middle half of the FVC</measure>
    <time_frame>12 months</time_frame>
    <description>Lung function parameters to predict asthma exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of absenteeism days from work/school</measure>
    <time_frame>12 months</time_frame>
    <description>Effect of the use of telemedicinal system for the asthma control</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Asthma in Children</condition>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Telemedicine arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inclouded telespirometry system</intervention_name>
    <description>Components of the system: Portable digital ultrasonic spirometer (Uscom SpiroSonic MOBILE), android mobile application, clinical web cloud application</description>
    <arm_group_label>Telemedicine arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years&#xD;
&#xD;
          -  signed ICF&#xD;
&#xD;
          -  asthmatic children with 2-5 GINA score&#xD;
&#xD;
          -  The children is open-minded for telespirometric measurements at home and is capable&#xD;
             for those measurements&#xD;
&#xD;
          -  Parent understands and supports the investigation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Withdrawal of consent&#xD;
&#xD;
          -  Any disease which, by the investigators opinion, is a risk for the patients health&#xD;
             and/or is contraindicating the participation in the study&#xD;
&#xD;
          -  Bad general condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Katalin Kapus, MD</last_name>
    <phone>+3662545331</phone>
    <email>kapus.katalin@med.u-szeged.hu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Szeged</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <contact>
      <last_name>Balázs Bende, Md</last_name>
      <phone>+36-62-546-895</phone>
      <email>bende.balazs@med.u-szeged.hu</email>
    </contact>
    <investigator>
      <last_name>Zoltán Novák, Prof. MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spirometry</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/NCT04447664
org study id: TMED_SPIRO_001
nct id: NCT04447664
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Asthma is the most common respiratory disorder in children that causes breathing problems.
      The patients may have respiratory symptoms such as cough, wheeze, or short of breath. Asthma
      can be mild or severe when daily activities become compromised. Generally, by application of
      proper treatment, asthma symptoms can be well controlled. However, the exacerbation of the
      disease often leads to acute respiratory adverse events that require hospitalization and
      school absenteeism.

      In this study, we plan the remote monitoring of lung function parameters in asthmatic
      children (under 18 years of age). We hypothesize that the daily home monitoring of
      respiratory indices will predict the occurrence of exacerbation and the hospitalization can
      be lowered.

      Asthmatic children arriving for the regular examinations to the Department of Pediatrics and
      Pediatric Health Care Center of the University of Szeged will be involved. The patients are
      randomly divided into two treatment groups, telemonitoring and control.

      For both groups, general patient characteristics will be recorded, and lung function
      parameters will be measured with a clinical spirometer.

      Patients in the telemedicine group receive the home mobile controlled spirometer and trained
      by a pediatric pulmonologist for home examination. The spirometers are handed for 12 months,
      and children are asked to perform measurements minimum 4 times per week (at least one day a
      week in the morning and in the evening). In the case of asthma attacks, more frequent
      measurements repeated several times a day are required. Children in the telemedicine group
      complete the Asthma Control Test (ACT) after each measurement, which provides a numerical
      score related to the severity of asthma symptoms. Lung function parameters measured by
      children and the ACT results are automatically uploaded to a clinical server where the
      pulmonologists and built-in algorithms are monitoring the quality of the data. In case of
      deterioration of the lung function parameters, the patients are called for a personal visit
      and their treatment can be revised.

      Every three months, members of both groups come to the outpatient clinic for a personal
      visit, where the same examinations are performed.
Asthma is the most common respiratory disorder in children characterized by periodic airway
      obstruction, bronchial hyper-responsiveness, and airway inflammation. The symptoms of asthma
      may include cough, wheeze, or bronchoconstriction with airflow limitation. The severity of
      asthma may vary from mild to severe. Mild asthma is associated with rear events of short of
      breath. However, the exacerbation of the disease often leads to acute respiratory adverse
      events with severe hypoxia that requires hospitalization. The hospital care involves travel
      costs for the children and parents, school and work absenteeism.

      The primary objective of the study is to investigate whether the annual occurrence of asthma
      exacerbation can be decreased by the use of the telespirometry system. Another objective is
      to determine which lung function parameters are best to predict asthma exacerbation.

      To address these aims we plan to involve two groups (telemonitoring and control) of asthmatic
      children with GINA 2-5 stage under 18 years of age. Poor general condition, any disease which
      endangers the health of the volunteer or contraindicates the study and lack of parental
      consent are defined as the exclusion criteria.

      The lung function in the children in both groups will be monitored by conventional
      spirometric assessment performed at the Department of Pediatrics and Pediatric Health Care
      Center of the University of Szeged. After each lung function assessments children will be
      asked to fill the Asthma Control Test (ACT).

      Patients in the telemedicine group receive the home mobile controlled spirometer and trained
      by a pediatric pulmonologist for home examination. The spirometers are handed for 12 months,
      and children are asked to perform measurements minimum 4 times per week (at least one day a
      week in the morning and in the evening). In the case of asthma exacerbation, more frequent
      measurements repeated several times a day are required. Children in the telemedicine group
      complete the ACT after each measurement, which provides a numerical score related to the
      severity of asthma symptoms. Lung function parameters measured by children and the ACT test
      results are automatically uploaded to a clinical server where the pulmonologists and built-in
      algorithms are monitoring the quality of the data. In case of deterioration of the lung
      function parameters, the patients are called for a personal visit and their treatment can be
      revised.

      Every three months, members of both groups come to the outpatient clinic for a personal
      visit, where the same examinations are performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Incidence of asthma exacerbations per year
time frame: 12 months
description: Change of the incidence of asthma exacerbations per year using telespirometry system
measure: expiratory Forced Vital Capacity (FVC), the maximum amount of air that can forcibly be blown out after full inspiration
time frame: 12 months
description: Lung function parameters to predict asthma exacerbation
measure: Forced Expiratory Volume in one second (FEV1), is the volume of air that can forcibly be blown out in first 1 second after full inspiration
time frame: 12 months
description: Lung function parameters to predict asthma exacerbation
measure: FEV1/FVC ratio (FEV1%)
time frame: 12 months
description: Lung function parameters to predict asthma exacerbation
measure: Peak Expiratory Flow (PEF), peak expiratory flow rate during expiration
time frame: 12 months
description: Lung function parameters to predict asthma exacerbation
measure: Forced Expiratory Flow at 25-75% of FVC (FEF25-75%), mean of forced expiratory flow over the middle half of the FVC
time frame: 12 months
description: Lung function parameters to predict asthma exacerbation
measure: The change of absenteeism days from work/school
time frame: 12 months
description: Effect of the use of telemedicinal system for the asthma control
arm group label: Telemedicine arm
arm group type: Experimental
arm group label: Control arm
arm group type: No Intervention
intervention type: Device
intervention name: Inclouded telespirometry system
description: Components of the system: Portable digital ultrasonic spirometer (Uscom SpiroSonic MOBILE), android mobile application, clinical web cloud application
arm group label: Telemedicine arm
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Katalin Kapus, MD
phone: +3662545331
email: kapus.katalin@med.u-szeged.hu
facility: 
contact: 
investigator: 
country: Hungary
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No