Bronchoscopic Lung Volume Reduction Using Blood

Launched by CHELSEA AND WESTMINSTER NHS FOUNDATION TRUST · Feb 3, 2012

Keywords

ClinConnect Summary

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 r...

Gender

ALL

Eligibility criteria

• 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