Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema

Study Overview
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Brief Summary
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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.

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

Conditions
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Bullous Emphysema

Intervention / Treatment
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* Procedure: Bronchoscopic intrabullous autologous blood instillation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIABI arm<br>Patients will undergo intrabullous autologous blood instillation | Procedure: Bronchoscopic intrabullous autologous blood instillation<br> <br> * Other names: BIABI;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emphysema, Chronic obstructive pulmonary disease, COPD, Bulla, Interventional bronchoscopy, Lung volume reduction