A Randomised, Double Blind, Sham Controlled Trial of Autologous Blood Lung Volume Reduction
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Evidence of scarring and volume loss on CT scanning
Study Overview
Brief Summary
The prupose of this study is to determine the feasibility, effectiveness, and safety of injecting blood into the airways to cause lung volume reduction in people with severe emphysema.
Detailed Description
This will be a randomised, double blind, placebo controlled trial where the response in patients treated with blood LVR will be compared to patients treated with placebo (control group). Analysis will evaluate the mean change in lobar lung volumes as determined by computed tomography (CT) scanning at 6 weeks in two study arms based on subjects' blinded bronchoscopic intervention.
Initial assessment will comprise
- Clinical evaluation
- Full pulmonary function tests (PFTs) - static and dynamic lung volumes and gas transfer
- SGRQ
- Dyspnoea Score
- CT scan
Suitable patients will then be randomised to receive either autologous blood, or normal saline injected into the target airways.
Procedures in all patients will be carried out under conscious sedation and/or anaesthesia. After bronchoscopic examination of the airways, 100ml of the patients own blood will be collected using two 50ml syringes. A balloon catheter will be inserted into the target segment and 25 mls of the blood will be injected via the balloon catheter. The balloon will be inflated and maintained in position for about 6 minutes in order to minimise the risk of overspill of blood into other areas of the lung. The balloon catheter will then be repositioned in the next segment of the target lobe of the lung and the process repeated until all the segments are treated. It is anticipated that the whole procedure will last 45-60 minutes, up to and including balloon removal.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-80 years
- •Moderate to severe airflow obstruction FEV1 <50% Predicted
- •Severe dyspnoea - mMRC ≥2
- •Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
- •Optimum COPD treatment for at least 6 weeks
- •No COPD exacerbation for at least 6 weeks
- •Less than 3 admissions for exacerbation in the preceding 12 months
Exclusion Criteria
- •Patient unable to provide informed consent
- •Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted
- •pO2 on air <6.0kPa
- •pCO2 on air >8.0kPa
- •Other major medical illness, e.g. lung cancer that will limit participation
- •Clinically significant bronchiectasis
- •Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
- •Arrhythmia or cardiovascular disease that poses a risk during procedure
- •Prednisolone dose greater than 10mg a day
- •Prior LVRS or lobectomy
- •Lung nodule requiring surgery
- •Female of childbearing age with positive pregnancy test
- •Subject participated in a research study of investigational drug or device in prior 30 days
- •Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Outcomes
Primary Outcomes
Evidence of scarring and volume loss on CT scanning
Time Frame: 6 weeks
Secondary Outcomes
- To ensure no significant lung function deteriorations at 6 weeks post-procedure(6 weeks)