Clinical trial NCT01727037: Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema
Official title: A Feasibility and Safety Study of Bronchoscopic Intrabullous Autologous Blood Instillation for the Treatment of Severe Bullous Emphysema (BIABI Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bullous Emphysema
Keywords: Emphysema
Chronic obstructive pulmonary disease
COPD
Bulla
Interventional bronchoscopy
Lung volume reduction
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Residual Volume (RV) following treatment
timeFrame: 6 months
Secondary outcomes:
measure: Change in TLC 6 months following treatment
timeFrame: 6 months
measure: Change in RV/TLC ratio 6 months following treatment
timeFrame: 6 months
measure: Changes in FEV1 and FVC 6 months following treatment
timeFrame: 6 months
measure: Change in the intrathoracic gas volume 6 months following treatment
timeFrame: 6 months
measure: Change in DLCOc 6 months following treatment
timeFrame: 6 months
measure: Change in the SGRQ score 6 months following treatment
timeFrame: 6 months
measure: Change in the mMRC score 6 months following treatment
timeFrame: 6 months
measure: Change in the 6MWD 6 months following treatment
timeFrame: 6 months
measure: Change in CT measured lung volumes 6 months following treatment
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 monhts
Other outcomes:
Locations:
city: Mansfield,
country: United Kingdom
facility: Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust
state: Nottinghamshire,
city: London
country: United Kingdom
facility: The Royal Brompton and Harefield NHS Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation trust
Study officials:
affiliation: Royal Brompton and Chelsea and Westminster Hospitals
name: Pallav L Shah, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References: