<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/NCT01727037</url>
  </required_header>
  <id_info>
    <org_study_id>BIABI v1</org_study_id>
    <nct_id>NCT01727037</nct_id>
  </id_info>
  <brief_title>Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema</brief_title>
  <acronym>BIABI</acronym>
  <official_title>A Feasibility and Safety Study of Bronchoscopic Intrabullous Autologous Blood Instillation for the Treatment of Severe Bullous Emphysema (BIABI Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chelsea and Westminster NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chelsea and Westminster NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with large bullae (large empty air sacs in the lung) may benefit from bullectomy&#xD;
      (surgery to resect these bullae), however this is a major surgery with significant potential&#xD;
      morbidity and long hospital stays. Many patients are not well enough to have this surgery, or&#xD;
      may not wish to have it. A less invasive means of attempting to shrink the size of the bullae&#xD;
      is to directly inject the patients' own blood into the bullae (we believe that this can lead&#xD;
      to an inflammatory reaction leading to gradual scarring and volume loss). This can be&#xD;
      performed bronchoscopically in a 20-30 minute procedure using conscious sedation (avoiding&#xD;
      general anaesthesia).&#xD;
&#xD;
      The aim of this study is to assess the effects on lung function, quality of life measures,&#xD;
      functional measures and CT measured lung volumes of bronchoscopic intrabullous blood&#xD;
      instillation in patients with bullous emphysema.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Residual Volume (RV) following treatment</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in TLC 6 months following treatment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in RV/TLC ratio 6 months following treatment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in FEV1 and FVC 6 months following treatment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the intrathoracic gas volume 6 months following treatment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in DLCOc 6 months following treatment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the SGRQ score 6 months following treatment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the mMRC score 6 months following treatment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the 6MWD 6 months following treatment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CT measured lung volumes 6 months following treatment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>6 monhts</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Bullous Emphysema</condition>
  <arm_group>
    <arm_group_label>BIABI arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo intrabullous autologous blood instillation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bronchoscopic intrabullous autologous blood instillation</intervention_name>
    <arm_group_label>BIABI arm</arm_group_label>
    <other_name>BIABI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 35 years&#xD;
&#xD;
          -  Large bulla on CT scan where bullectomy is contraindicated or is actively avoided.&#xD;
&#xD;
          -  Hyperinflation - TLC ≥100% predicted, RV ≥150% predicted&#xD;
&#xD;
          -  Exertional breathlessness (mMRC &gt;0)&#xD;
&#xD;
          -  Optimum COPD treatment for at least 6 weeks&#xD;
&#xD;
          -  No COPD exacerbation for at least 6 weeks&#xD;
&#xD;
          -  Fewer than 3 admissions for infective exacerbations in the preceding 12 months&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to obtain informed consent&#xD;
&#xD;
          -  Co-morbidities that would render bronchoscopy or sedation unsafe.&#xD;
&#xD;
          -  Anaemia or other reasons precluding venesection.&#xD;
&#xD;
          -  Clinically significant bronchiectasis&#xD;
&#xD;
          -  Arrhythmia or cardiovascular disease that poses a risk during procedure&#xD;
&#xD;
          -  Lung nodule requiring further investigation or treatment&#xD;
&#xD;
          -  Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain&#xD;
             for 5 days pre-procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pallav L Shah, MD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton and Chelsea and Westminster Hospitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zaid Zoumot, MBBS MRCP MSc</last_name>
    <phone>+442073518029</phone>
    <email>zzoumot@doctors.org.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust</name>
      <address>
        <city>Mansfield,</city>
        <state>Nottinghamshire,</state>
        <zip>N</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samuel V Kemp, MBBs MRCP</last_name>
      <phone>+44162362251</phone>
    </contact>
    <investigator>
      <last_name>Samuel V Kemp, MBBS, MRCP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Royal Brompton and Harefield NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zaid Zoumot, MBBS MRCP MSc</last_name>
      <phone>+442073518029</phone>
      <email>zzoumot@doctors.otg.uk</email>
    </contact>
    <investigator>
      <last_name>Zaid Zoumot, MBBS MRCP MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital NHS Foundation trust</name>
      <address>
        <city>London</city>
        <zip>SW9 0HN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zaid Zoumot, MBBS MRCP MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 19, 2012</last_update_submitted>
  <last_update_submitted_qc>November 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emphysema</keyword>
  <keyword>Chronic obstructive pulmonary disease</keyword>
  <keyword>COPD</keyword>
  <keyword>Bulla</keyword>
  <keyword>Interventional bronchoscopy</keyword>
  <keyword>Lung volume reduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Emphysema</mesh_term>
    <mesh_term>Emphysema</mesh_term>
  </condition_browse>
  <!-- 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/NCT01727037
org study id: BIABI v1
nct id: NCT01727037
lead sponsor: 
has dmc: No
Patients with large bullae (large empty air sacs in the lung) may benefit from bullectomy
      (surgery to resect these bullae), however this is a major surgery with significant potential
      morbidity and long hospital stays. Many patients are not well enough to have this surgery, or
      may not wish to have it. A less invasive means of attempting to shrink the size of the bullae
      is to directly inject the patients' own blood into the bullae (we believe that this can lead
      to an inflammatory reaction leading to gradual scarring and volume loss). This can be
      performed bronchoscopically in a 20-30 minute procedure using conscious sedation (avoiding
      general anaesthesia).

      The aim of this study is to assess the effects on lung function, quality of life measures,
      functional measures and CT measured lung volumes of bronchoscopic intrabullous blood
      instillation in patients with bullous emphysema.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Residual Volume (RV) following treatment
time frame: 6 months
measure: Change in TLC 6 months following treatment
time frame: 6 months
measure: Change in RV/TLC ratio 6 months following treatment
time frame: 6 months
measure: Changes in FEV1 and FVC 6 months following treatment
time frame: 6 months
measure: Change in the intrathoracic gas volume 6 months following treatment
time frame: 6 months
measure: Change in DLCOc 6 months following treatment
time frame: 6 months
measure: Change in the SGRQ score 6 months following treatment
time frame: 6 months
measure: Change in the mMRC score 6 months following treatment
time frame: 6 months
measure: Change in the 6MWD 6 months following treatment
time frame: 6 months
measure: Change in CT measured lung volumes 6 months following treatment
time frame: 6 months
measure: Adverse events
time frame: 6 monhts
arm group label: BIABI arm
arm group type: Experimental
description: Patients will undergo intrabullous autologous blood instillation
intervention type: Procedure
intervention name: Bronchoscopic intrabullous autologous blood instillation
arm group label: BIABI arm
other name: BIABI
criteria: 
gender: All
minimum age: 35 Years
maximum age: 90 Years
healthy volunteers: No
last name: Pallav L Shah, MD FRCP
role: Principal Investigator
affiliation: Royal Brompton and Chelsea and Westminster Hospitals
last name: Zaid Zoumot, MBBS MRCP MSc
phone: +442073518029
email: zzoumot@doctors.org.uk
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pulmonary Emphysema
mesh term: Emphysema