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Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema (BIABI)

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ClinicalTrials.gov Identifier: NCT01727037
Recruitment Status : Unknown
Verified November 2012 by Chelsea and Westminster NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : November 15, 2012
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bullous Emphysema Procedure: Bronchoscopic intrabullous autologous blood instillation Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility and Safety Study of Bronchoscopic Intrabullous Autologous Blood Instillation for the Treatment of Severe Bullous Emphysema (BIABI Study)
Study Start Date : October 2012
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BIABI arm
Patients will undergo intrabullous autologous blood instillation
Procedure: Bronchoscopic intrabullous autologous blood instillation
Other Name: BIABI


Outcome Measures

Primary Outcome Measures :
  1. Change in the Residual Volume (RV) following treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in TLC 6 months following treatment [ Time Frame: 6 months ]
  2. Change in RV/TLC ratio 6 months following treatment [ Time Frame: 6 months ]
  3. Changes in FEV1 and FVC 6 months following treatment [ Time Frame: 6 months ]
  4. Change in the intrathoracic gas volume 6 months following treatment [ Time Frame: 6 months ]
  5. Change in DLCOc 6 months following treatment [ Time Frame: 6 months ]
  6. Change in the SGRQ score 6 months following treatment [ Time Frame: 6 months ]
  7. Change in the mMRC score 6 months following treatment [ Time Frame: 6 months ]
  8. Change in the 6MWD 6 months following treatment [ Time Frame: 6 months ]
  9. Change in CT measured lung volumes 6 months following treatment [ Time Frame: 6 months ]
  10. Adverse events [ Time Frame: 6 monhts ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 35 years
  • Large bulla on CT scan where bullectomy is contraindicated or is actively avoided.
  • Hyperinflation - TLC ≥100% predicted, RV ≥150% predicted
  • Exertional breathlessness (mMRC >0)
  • Optimum COPD treatment for at least 6 weeks
  • No COPD exacerbation for at least 6 weeks
  • Fewer than 3 admissions for infective exacerbations in the preceding 12 months
  • Written informed consent

Exclusion Criteria:

  • Inability to obtain informed consent
  • Co-morbidities that would render bronchoscopy or sedation unsafe.
  • Anaemia or other reasons precluding venesection.
  • Clinically significant bronchiectasis
  • Arrhythmia or cardiovascular disease that poses a risk during procedure
  • Lung nodule requiring further investigation or treatment
  • Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727037


Contacts
Contact: Zaid Zoumot, MBBS MRCP MSc +442073518029 zzoumot@doctors.org.uk

Locations
United Kingdom
Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust Recruiting
Mansfield,, Nottinghamshire,, United Kingdom, N
Contact: Samuel V Kemp, MBBs MRCP    +44162362251      
Principal Investigator: Samuel V Kemp, MBBS, MRCP         
The Royal Brompton and Harefield NHS Trust Recruiting
London, United Kingdom, SW3 6NP
Contact: Zaid Zoumot, MBBS MRCP MSc    +442073518029    zzoumot@doctors.otg.uk   
Sub-Investigator: Zaid Zoumot, MBBS MRCP MSc         
Chelsea and Westminster Hospital NHS Foundation trust Recruiting
London, United Kingdom, SW9 0HN
Sub-Investigator: Zaid Zoumot, MBBS MRCP MSc         
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Investigators
Principal Investigator: Pallav L Shah, MD FRCP Royal Brompton and Chelsea and Westminster Hospitals
More Information

Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01727037     History of Changes
Other Study ID Numbers: BIABI v1
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: November 2012

Keywords provided by Chelsea and Westminster NHS Foundation Trust:
Emphysema
Chronic obstructive pulmonary disease
COPD
Bulla
Interventional bronchoscopy
Lung volume reduction

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases