<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/NCT03261219</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201700115</org_study_id>
    <nct_id>NCT03261219</nct_id>
  </id_info>
  <brief_title>IPV vs CPT for Airway Clearance During CF Exacerbation</brief_title>
  <official_title>Intrapulmonary Percussive Ventilation vs Chest Physiotherapy Vest in Airway Clearance During Cystic Fibrosis Pulmonary Exacerbation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intrapulmonary Percussive Ventilation (IPV) will show greater improvements in Forced&#xD;
      Expiatory Volume in 1 second (FEV1) shorter duration of stay, and greater time to next&#xD;
      pulmonary exacerbation in pediatric Cystic Fibrosis patients admitted for pulmonary&#xD;
      exacerbation.&#xD;
&#xD;
      FEV1 is a measurement of obstruction in the airway which is seen to be elevated in CF&#xD;
      patients with worsening lung disease. FEV1 is used as a primary endpoint in pulmonary trials&#xD;
      because it is an acute indicator of worsening or improving lung function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be a prospective randomized clinical trial. All Cystic Fibrosis (CF) patients&#xD;
      five years and above who are being admitted to University of Florida (UF) Shands Children's&#xD;
      Hospital with the diagnosis of CF acute pulmonary exacerbations will be approached for study&#xD;
      consent on day one of hospitalization.&#xD;
&#xD;
      Each patient will be randomized to receive either IPV (metaneb) or Chest Physiotherapy (CPT)&#xD;
      vest (Incourage) therapy. Treatments will be administered by in-house respiratory therapists&#xD;
      four times daily according to standard protocol, and the respiratory therapist will document&#xD;
      each treatment in the patient's electronic medical record (EPIC). Each patient will also&#xD;
      receive mucolytic agents (dornase alpha, hypertonic saline) and antibiotic therapy as per&#xD;
      routine inpatient protocol per the attending pulmonologist on service. If the patient's&#xD;
      clinical status worsens during their admission the attending pulmonologist will be allowed to&#xD;
      change the airway clearance regimen or antibiotic coverage at their discretion.&#xD;
&#xD;
      If a patient is enrolled and has another admission for pulmonary exacerbation after their&#xD;
      initial admission, we will attempt to randomize them to the other arm and utilize this data&#xD;
      to see if there is a difference in outcome parameters for the same patient if they are&#xD;
      randomized to both arms.&#xD;
&#xD;
      The degree of improvement in FEV1 defined as absolute difference between admission FEV1 and&#xD;
      discharge FEV1 will be used as primary outcome measure to compare effectiveness between both&#xD;
      modalities. This measure is commonly used in the Cystic Fibrosis community of clinicians and&#xD;
      researchers as measure of airway obstruction and disease severity. We will perform spirometry&#xD;
      at least twice, at admission and discharge, on these patients. The patient's spirometry from&#xD;
      their office visit on the same day of admission or first spirometry during their admission&#xD;
      will count as the initial spirometry. Last spirometry obtained before discharge will be the&#xD;
      discharge spirometry. Additional spirometry may be performed during the patient's admission&#xD;
      at the attending provider's clinical discretion. We will also use data from these additional&#xD;
      spirometry measurements if they take place.&#xD;
&#xD;
      There will be no additional cost incurred by using the IPV device as opposed to standard of&#xD;
      care (CPT vest).There is also no increased effort performing IPV treatments from the&#xD;
      respiratory therapist performing the treatment or from the patient.&#xD;
&#xD;
      Length of hospital stay in days will be used as a secondary outcome.&#xD;
&#xD;
      Another secondary outcome measure will be the length of time between discharge and subsequent&#xD;
      admissions for CF pulmonary exacerbation. We will follow the subject for an additional 6&#xD;
      months after they are enrolled to ascertain the time to next admission and total number of&#xD;
      admissions in that time.&#xD;
&#xD;
      Other information that will be accessed through EPIC records will be number of admissions for&#xD;
      CF pulmonary exacerbations, airway clearance regimen, radiological data, laboratory results&#xD;
      (respiratory cultures, Respiratory Viral Panels, Acid Fast Bacilli cultures, complete Blood&#xD;
      counts), vital signs, weight measurements, Bronchoscopy reports, medications used (Orkambi,&#xD;
      Kalydeco, antibiotics), and oxygen requirement. All of this information will be collected in&#xD;
      the time period of 1 year before study and throughout study,&#xD;
&#xD;
      We will also administer a 2 question questionnaire at the beginning and end of admission to&#xD;
      the hospital in order to evaluate the patient/family opinion of the therapy they received&#xD;
      during their participation in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not renewed with IRB&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2018</start_date>
  <completion_date type="Anticipated">October 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FEV1 change</measure>
    <time_frame>duration of hospital stay (usually 10-14 days)</time_frame>
    <description>change in FEV1 from baseline at admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time to next admission</measure>
    <time_frame>from discharge to 6 months after discharge</time_frame>
    <description>time in days to next hospital admission for CF Pulmonary Exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction with airway clearance modality</measure>
    <time_frame>10 minutes after each discharge during study period</time_frame>
    <description>survey of satisfaction with prescribed airway clearance modality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of admission</measure>
    <time_frame>usually 10-14 days</time_frame>
    <description>length of admission in days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cystic Fibrosis</condition>
  <condition>Airway Clearance Impairment</condition>
  <arm_group>
    <arm_group_label>Intrapulmonary Percussive ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Chest Physiotherapy vest</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intrapulmonary Percussive ventilation</intervention_name>
    <description>mode of airway clearance using mouthpiece and alternating air currents applied directly to the airway</description>
    <arm_group_label>Intrapulmonary Percussive ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Chest Physiotherapy Vest (Incourage)</intervention_name>
    <description>mode of airway clearance using external vibratory vest</description>
    <arm_group_label>Chest Physiotherapy vest</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CF patient admitted for pulmonary exacerbation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not able to perform spirometry, patients with neurological impairment&#xD;
             (Cerebral Palsy) or severe behavioral problems that precludes consistent use of IPV,&#xD;
             patients with pneumothorax or significant hemoptysis, patients who require&#xD;
             supplemental oxygen or ventilatory support, or patients whose parents/guardians are&#xD;
             not willing to consent will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>October 17, 2018</last_update_submitted>
  <last_update_submitted_qc>October 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT03261219
org study id: IRB201700115
nct id: NCT03261219
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Intrapulmonary Percussive Ventilation (IPV) will show greater improvements in Forced
      Expiatory Volume in 1 second (FEV1) shorter duration of stay, and greater time to next
      pulmonary exacerbation in pediatric Cystic Fibrosis patients admitted for pulmonary
      exacerbation.

      FEV1 is a measurement of obstruction in the airway which is seen to be elevated in CF
      patients with worsening lung disease. FEV1 is used as a primary endpoint in pulmonary trials
      because it is an acute indicator of worsening or improving lung function.
The study will be a prospective randomized clinical trial. All Cystic Fibrosis (CF) patients
      five years and above who are being admitted to University of Florida (UF) Shands Children's
      Hospital with the diagnosis of CF acute pulmonary exacerbations will be approached for study
      consent on day one of hospitalization.

      Each patient will be randomized to receive either IPV (metaneb) or Chest Physiotherapy (CPT)
      vest (Incourage) therapy. Treatments will be administered by in-house respiratory therapists
      four times daily according to standard protocol, and the respiratory therapist will document
      each treatment in the patient's electronic medical record (EPIC). Each patient will also
      receive mucolytic agents (dornase alpha, hypertonic saline) and antibiotic therapy as per
      routine inpatient protocol per the attending pulmonologist on service. If the patient's
      clinical status worsens during their admission the attending pulmonologist will be allowed to
      change the airway clearance regimen or antibiotic coverage at their discretion.

      If a patient is enrolled and has another admission for pulmonary exacerbation after their
      initial admission, we will attempt to randomize them to the other arm and utilize this data
      to see if there is a difference in outcome parameters for the same patient if they are
      randomized to both arms.

      The degree of improvement in FEV1 defined as absolute difference between admission FEV1 and
      discharge FEV1 will be used as primary outcome measure to compare effectiveness between both
      modalities. This measure is commonly used in the Cystic Fibrosis community of clinicians and
      researchers as measure of airway obstruction and disease severity. We will perform spirometry
      at least twice, at admission and discharge, on these patients. The patient's spirometry from
      their office visit on the same day of admission or first spirometry during their admission
      will count as the initial spirometry. Last spirometry obtained before discharge will be the
      discharge spirometry. Additional spirometry may be performed during the patient's admission
      at the attending provider's clinical discretion. We will also use data from these additional
      spirometry measurements if they take place.

      There will be no additional cost incurred by using the IPV device as opposed to standard of
      care (CPT vest).There is also no increased effort performing IPV treatments from the
      respiratory therapist performing the treatment or from the patient.

      Length of hospital stay in days will be used as a secondary outcome.

      Another secondary outcome measure will be the length of time between discharge and subsequent
      admissions for CF pulmonary exacerbation. We will follow the subject for an additional 6
      months after they are enrolled to ascertain the time to next admission and total number of
      admissions in that time.

      Other information that will be accessed through EPIC records will be number of admissions for
      CF pulmonary exacerbations, airway clearance regimen, radiological data, laboratory results
      (respiratory cultures, Respiratory Viral Panels, Acid Fast Bacilli cultures, complete Blood
      counts), vital signs, weight measurements, Bronchoscopy reports, medications used (Orkambi,
      Kalydeco, antibiotics), and oxygen requirement. All of this information will be collected in
      the time period of 1 year before study and throughout study,

      We will also administer a 2 question questionnaire at the beginning and end of admission to
      the hospital in order to evaluate the patient/family opinion of the therapy they received
      during their participation in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: FEV1 change
time frame: duration of hospital stay (usually 10-14 days)
description: change in FEV1 from baseline at admission
measure: time to next admission
time frame: from discharge to 6 months after discharge
description: time in days to next hospital admission for CF Pulmonary Exacerbation
measure: Patient Satisfaction with airway clearance modality
time frame: 10 minutes after each discharge during study period
description: survey of satisfaction with prescribed airway clearance modality
measure: Length of admission
time frame: usually 10-14 days
description: length of admission in days
arm group label: Intrapulmonary Percussive ventilation
arm group type: Experimental
arm group label: Chest Physiotherapy vest
arm group type: Active Comparator
intervention type: Device
intervention name: Intrapulmonary Percussive ventilation
description: mode of airway clearance using mouthpiece and alternating air currents applied directly to the airway
arm group label: Intrapulmonary Percussive ventilation
intervention type: Device
intervention name: Chest Physiotherapy Vest (Incourage)
description: mode of airway clearance using external vibratory vest
arm group label: Chest Physiotherapy vest
criteria: 
gender: All
minimum age: 5 Years
maximum age: 21 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No