Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01727037

Acronym

BIABI

Enrollment

Registered

2012-11-15

Start date

2012-10-31

Completion date

Unknown

Last updated

2012-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bullous Emphysema

Keywords

Emphysema, Chronic obstructive pulmonary disease, COPD, Bulla, Interventional bronchoscopy, Lung volume reduction

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.

Interventions

PROCEDUREBronchoscopic intrabullous autologous blood instillation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 TLC 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
Change in the SGRQ score 6 months following treatment	6 months

Countries

United Kingdom

Contacts

Primary ContactZaid Zoumot, MBBS MRCP MSc

zzoumot@doctors.org.uk+442073518029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026