Bullous Emphysema Clinical Trial
— BIABIOfficial title:
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 90 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Chelsea and Westminster Hospital NHS Foundation trust | London | |
| United Kingdom | The Royal Brompton and Harefield NHS Trust | London | |
| United Kingdom | Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust | Mansfield, | Nottinghamshire, |
| Lead Sponsor | Collaborator |
|---|---|
| Chelsea and Westminster NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in the Residual Volume (RV) following treatment | 6 months | No | |
| Secondary | Change in TLC 6 months following treatment | 6 months | No | |
| Secondary | Change in RV/TLC ratio 6 months following treatment | 6 months | No | |
| Secondary | Changes in FEV1 and FVC 6 months following treatment | 6 months | No | |
| Secondary | Change in the intrathoracic gas volume 6 months following treatment | 6 months | No | |
| Secondary | Change in DLCOc 6 months following treatment | 6 months | No | |
| Secondary | Change in the SGRQ score 6 months following treatment | 6 months | No | |
| Secondary | Change in the mMRC score 6 months following treatment | 6 months | No | |
| Secondary | Change in the 6MWD 6 months following treatment | 6 months | No | |
| Secondary | Change in CT measured lung volumes 6 months following treatment | 6 months | No | |
| Secondary | Adverse events | 6 monhts | No |