Status:
COMPLETED
Bronchoscopic Lung Volume Reduction Using Blood
Lead Sponsor:
Chelsea and Westminster NHS Foundation Trust
Conditions:
Emphysema
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01528267
Start Date
November 1 2009
End Date
March 1 2013
Last Update
December 20 2013
Active Locations (1)
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1
Chelsea and Westminster NHS Foundation Trust
London, United Kingdom