<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/NCT02982876</url>
  </required_header>
  <id_info>
    <org_study_id>2016P000246</org_study_id>
    <nct_id>NCT02982876</nct_id>
  </id_info>
  <brief_title>Airway Stents for Excessive Dynamic Airway Collapse</brief_title>
  <official_title>Airway Stents for Excessive Dynamic Airway Collapse: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Association of Broncology and Interventional Pulmonology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Curetbm.org Fundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hood Laboratories</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Medical products inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Airway stents are used as standard of care to identify which patients with excessive dynamic&#xD;
      airway collapse will benefit from a definitive surgical treatment. However, the specific way&#xD;
      in which these stents are effective has not been tested. The purpose of this research study&#xD;
      is to determine the effectiveness of airway stents when used in the airways of patients with&#xD;
      severe symptomatic excessive dynamic airway collapse compared to patients with severe&#xD;
      symptomatic excessive dynamic airway collapse that do not receive airway stent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design&#xD;
&#xD;
      This randomized controlled trial will be conducted at Beth Israel Deaconess Medical Center&#xD;
      (BIDMC) in accordance with Good Clinical Practice Standards and under IRB supervision. We&#xD;
      plan to enroll total of 48 patients with EDAC randomized by a computer generated system to&#xD;
      either intervention group (airway stent) or medical management group.&#xD;
&#xD;
      Description of the study&#xD;
&#xD;
      Previous to appointment all patients will have Airway CT scan, 6 minute walk test and&#xD;
      pulmonary function test as per protocol and standard of care.&#xD;
&#xD;
      Enrollment&#xD;
&#xD;
      Patients with severe EDAC who remain symptomatic despite optimal medical management will be&#xD;
      informed about the trial and if interested will be recruited for the study.&#xD;
&#xD;
      Operative Technique&#xD;
&#xD;
      Patients in the treatment group (stent) will undergo bronchoscopy under light sedation and&#xD;
      rigid bronchoscopy under general anesthesia. The treatment group will undergo a bronchial&#xD;
      wash and placement of an airway stent.Patients assigned to the medical management group will&#xD;
      not undergo bronchoscopy.&#xD;
&#xD;
      Stents&#xD;
&#xD;
      Based on the patient's airway anatomy an uncovered self-expanding metallic stent (Ultraflex™&#xD;
      Single-Use Tracheobronchial Stent System) or a silicone Y-stent(Endoxane, Novatech S.A.,&#xD;
      Aubagne-France or Channick Hood Laboratories, Pembroke, MA, 02359) will be used in the study.&#xD;
&#xD;
      During Stent Trial&#xD;
&#xD;
      After bronchoscopy, patients in the treatment group will receive a standardized medication&#xD;
      regimen to include mucolytics, cough suppressors and expectorants in order to decrease the&#xD;
      risk of potential complications following the procedure.&#xD;
&#xD;
      Follow-up&#xD;
&#xD;
      All participants will be scheduled for a follow-up visit in the following 14 days either&#xD;
      after rigid bronchoscopy (treatment group) or after first visit (medical management group)&#xD;
      with 6MWTs and PFTs. In this visit all patients will be asked to complete the SGRQ, CQLQ and&#xD;
      mMRC questionnaires by the research team. All this data will be recorded in an encrypted&#xD;
      database. Afterwards, the patients in the medical management arm will be offered a stent&#xD;
      trial as part of standard of care.&#xD;
&#xD;
      Stent removal&#xD;
&#xD;
      The patients from the treatment arm will be scheduled for a rigid bronchoscopy, stent removal&#xD;
      and bronchial lavage under anesthesia in the operating room.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>St. George's Respiratory Questionnaire</measure>
    <time_frame>7-14 days</time_frame>
    <description>Index designed to measure health status in patients with respiratory symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>modified Medical Research Council scale of dyspnea</measure>
    <time_frame>7-14 days</time_frame>
    <description>Shortness of breath scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cough Quality of life Questionnaire</measure>
    <time_frame>7-14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 minute walk test</measure>
    <time_frame>7-14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1</measure>
    <time_frame>7-14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak flow</measure>
    <time_frame>7-14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported symptoms</measure>
    <time_frame>7-14 days</time_frame>
    <description>dyspnea, inability to clear secretions, cough, recurrent infection and wheezing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>7-14 days</time_frame>
    <description>Airway infections</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Tracheobronchomalacia</condition>
  <condition>Excessive Dynamic Airway Collapse</condition>
  <arm_group>
    <arm_group_label>Medical Management Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients assigned to the medical management group will be placed on a scheduled institution protocol using mucolytic and expectorant therapy (nebulizer treatments using mucolytic (N-acetylcysteine) for 15 minutes BID, Guafenesin (Mucinex®) 1200 mg BID, codeine as needed and Flutter valve BID.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dynamic Flexible Bronchoscopy</intervention_name>
    <description>The bronchoscope will be introduced into the proximal trachea at the level of the cricoid. At that point, patients will be instructed to take a deep breath, hold it and then blow it out (forced expiratory maneuver). Maneuvers will be done at the following six sites: proximal trachea at the level of the cricoid; mid-trachea 5 cm proximal to the carina; distal trachea 2 cm proximal to the carina; right main stem bronchus at the right tracheobronchial angle; bronchus intermedius and left main bronchus at the left tracheobronchial angle</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rigid Bronchoscopy</intervention_name>
    <description>Under general anesthesia, a rigid bronchoscope (Bryan-Dumon Series II; Bryan Corporation; Woburn, MA) will be introduced, and respiration will be maintained through jet ventilation.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stent placement</intervention_name>
    <description>Silicone Y stent or uncovered self-expanding metallic stent will be placed in the standard fashion and good fit will be confirmed visually.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with sever symptomatic EDAC (collapse &gt;90% of the airway during exhalation at&#xD;
             dynamic CT scan)&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have not been well managed from their respiratory comorbidities (asthma,&#xD;
             COPD, obstructed sleep apnea, GERD, relapsing polychondritis)&#xD;
&#xD;
          -  Current respiratory infection&#xD;
&#xD;
          -  Resting bradycardia (&lt;50 beats/min), frequent multifocal PVCs, complex ventricular&#xD;
             arrhythmia, sustained SVT&#xD;
&#xD;
          -  Dysrhythmia that might pose a risk during exercise or training&#xD;
&#xD;
          -  Any disease or condition that interferes with completion of initial or follow-up&#xD;
             assessments&#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>Adnan Majid, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
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  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>April 14, 2023</last_update_submitted>
  <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Adnan Majid, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Silicone Airway stent</keyword>
  <keyword>Metallic Airway stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tracheobronchomalacia</mesh_term>
    <mesh_term>Bronchomalacia</mesh_term>
    <mesh_term>Shock</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/NCT02982876
org study id: 2016P000246
nct id: NCT02982876
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Airway stents are used as standard of care to identify which patients with excessive dynamic
      airway collapse will benefit from a definitive surgical treatment. However, the specific way
      in which these stents are effective has not been tested. The purpose of this research study
      is to determine the effectiveness of airway stents when used in the airways of patients with
      severe symptomatic excessive dynamic airway collapse compared to patients with severe
      symptomatic excessive dynamic airway collapse that do not receive airway stent.
Study Design

      This randomized controlled trial will be conducted at Beth Israel Deaconess Medical Center
      (BIDMC) in accordance with Good Clinical Practice Standards and under IRB supervision. We
      plan to enroll total of 48 patients with EDAC randomized by a computer generated system to
      either intervention group (airway stent) or medical management group.

      Description of the study

      Previous to appointment all patients will have Airway CT scan, 6 minute walk test and
      pulmonary function test as per protocol and standard of care.

      Enrollment

      Patients with severe EDAC who remain symptomatic despite optimal medical management will be
      informed about the trial and if interested will be recruited for the study.

      Operative Technique

      Patients in the treatment group (stent) will undergo bronchoscopy under light sedation and
      rigid bronchoscopy under general anesthesia. The treatment group will undergo a bronchial
      wash and placement of an airway stent.Patients assigned to the medical management group will
      not undergo bronchoscopy.

      Stents

      Based on the patient's airway anatomy an uncovered self-expanding metallic stent (Ultraflex™
      Single-Use Tracheobronchial Stent System) or a silicone Y-stent(Endoxane, Novatech S.A.,
      Aubagne-France or Channick Hood Laboratories, Pembroke, MA, 02359) will be used in the study.

      During Stent Trial

      After bronchoscopy, patients in the treatment group will receive a standardized medication
      regimen to include mucolytics, cough suppressors and expectorants in order to decrease the
      risk of potential complications following the procedure.

      Follow-up

      All participants will be scheduled for a follow-up visit in the following 14 days either
      after rigid bronchoscopy (treatment group) or after first visit (medical management group)
      with 6MWTs and PFTs. In this visit all patients will be asked to complete the SGRQ, CQLQ and
      mMRC questionnaires by the research team. All this data will be recorded in an encrypted
      database. Afterwards, the patients in the medical management arm will be offered a stent
      trial as part of standard of care.

      Stent removal

      The patients from the treatment arm will be scheduled for a rigid bronchoscopy, stent removal
      and bronchial lavage under anesthesia in the operating room.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: St. George's Respiratory Questionnaire
time frame: 7-14 days
description: Index designed to measure health status in patients with respiratory symptoms
measure: modified Medical Research Council scale of dyspnea
time frame: 7-14 days
description: Shortness of breath scale
measure: Cough Quality of life Questionnaire
time frame: 7-14 days
measure: 6 minute walk test
time frame: 7-14 days
measure: FEV1
time frame: 7-14 days
measure: Peak flow
time frame: 7-14 days
measure: Self-reported symptoms
time frame: 7-14 days
description: dyspnea, inability to clear secretions, cough, recurrent infection and wheezing.
measure: Complications
time frame: 7-14 days
description: Airway infections
arm group label: Medical Management Group
arm group type: No Intervention
description: The patients assigned to the medical management group will be placed on a scheduled institution protocol using mucolytic and expectorant therapy (nebulizer treatments using mucolytic (N-acetylcysteine) for 15 minutes BID, Guafenesin (Mucinex®) 1200 mg BID, codeine as needed and Flutter valve BID.
arm group label: Treatment group
arm group type: Active Comparator
description: The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement
intervention type: Procedure
intervention name: Dynamic Flexible Bronchoscopy
description: The bronchoscope will be introduced into the proximal trachea at the level of the cricoid. At that point, patients will be instructed to take a deep breath, hold it and then blow it out (forced expiratory maneuver). Maneuvers will be done at the following six sites: proximal trachea at the level of the cricoid; mid-trachea 5 cm proximal to the carina; distal trachea 2 cm proximal to the carina; right main stem bronchus at the right tracheobronchial angle; bronchus intermedius and left main bronchus at the left tracheobronchial angle
arm group label: Treatment group
intervention type: Procedure
intervention name: Rigid Bronchoscopy
description: Under general anesthesia, a rigid bronchoscope (Bryan-Dumon Series II; Bryan Corporation; Woburn, MA) will be introduced, and respiration will be maintained through jet ventilation.
arm group label: Treatment group
intervention type: Device
intervention name: Stent placement
description: Silicone Y stent or uncovered self-expanding metallic stent will be placed in the standard fashion and good fit will be confirmed visually.
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adnan Majid, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
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responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Adnan Majid, MD
investigator title: MD
mesh term: Tracheobronchomalacia
mesh term: Bronchomalacia
mesh term: Shock
sharing ipd: No