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

A Feasibility and Safety Study of Bronchoscopic Intrabullous Autologous Blood Instillation for the Treatment of Severe Bullous Emphysema (BIABI Study)

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.

Study Overview

• Status: Unknown
• Conditions: Bullous Emphysema
• Intervention / Treatment: Procedure: Bronchoscopic intrabullous autologous blood instillation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zaid Zoumot, MBBS MRCP MSc; Phone Number: +442073518029; Email: zzoumot@doctors.org.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Recruiting
    • The Royal Brompton and Harefield NHS Trust
    • Contact: Zaid Zoumot, MBBS MRCP MSc; Phone Number: +442073518029; Email: zzoumot@doctors.otg.uk
    • Sub-Investigator: Zaid Zoumot, MBBS MRCP MSc
  • London, United Kingdom, SW9 0HN
    • Recruiting
    • Chelsea And Westminster Hospital NHS Foundation Trust
    • Sub-Investigator: Zaid Zoumot, MBBS MRCP MSc
  • Nottinghamshire,
    • Mansfield,, Nottinghamshire,, United Kingdom, N
      • Recruiting
      • Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust
      • Contact: Samuel V Kemp, MBBs MRCP; Phone Number: +44162362251
      • Principal Investigator: Samuel V Kemp, MBBS, MRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIABI arm; Patients will undergo intrabullous autologous blood instillation	Procedure: Bronchoscopic intrabullous autologous blood instillation; Other Names: BIABI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the Residual Volume (RV) following treatment	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in TLC 6 months following treatment	6 months
Change in RV/TLC ratio 6 months following treatment	6 months
Changes in FEV1 and FVC 6 months following treatment	6 months
Change in the intrathoracic gas volume 6 months following treatment	6 months
Change in DLCOc 6 months following treatment	6 months
Change in the SGRQ score 6 months following treatment	6 months
Change in the mMRC score 6 months following treatment	6 months
Change in the 6MWD 6 months following treatment	6 months
Change in CT measured lung volumes 6 months following treatment	6 months
Adverse events	6 monhts

Collaborators and Investigators

• Sponsor: Chelsea and Westminster NHS Foundation Trust
• Investigators: Principal Investigator: Pallav L Shah, MD FRCP, Royal Brompton and Chelsea and Westminster Hospitals

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: November 12, 2012
• First Submitted That Met QC Criteria: November 12, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Estimate): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 19, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: COPD; Chronic obstructive pulmonary disease; Emphysema; Bulla; Interventional bronchoscopy; Lung volume reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: BIABI v1