A Feasibility and Safety Study of Bronchoscopic Intrabullous Autologous Blood Instillation for the Treatment of Severe Bullous Emphysema (BIABI Study)
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- Change in the Residual Volume (RV) following treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BIABI arm
Patients will undergo intrabullous autologous blood instillation
Intervention: Bronchoscopic intrabullous autologous blood instillation (Procedure)
Outcomes
Primary Outcomes
Change in the Residual Volume (RV) following treatment
Time Frame: 6 months
Secondary Outcomes
- Change in RV/TLC ratio 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)
- Change in TLC 6 months following treatment(6 months)
- Change in the intrathoracic gas volume 6 months following treatment(6 months)
- Adverse events(6 monhts)
- Changes in FEV1 and FVC 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 DLCOc 6 months following treatment(6 months)