Status:
COMPLETED
Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Heterogeneous Emphysema
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive re...
Eligibility Criteria
Inclusion
- Age 18-80 years
- Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels
- Moderate to severe airflow obstruction FEV1 \<50% Predicted
- Severe dyspnoea - mMRC ≥2
- Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
- SWT ≥75m
- Optimum COPD treatment for at least 6 weeks
- No COPD exacerbation for at least 6 weeks
- Less than 4 admissions for exacerbation in the preceding 12 months
Exclusion
- Patient unable to provide informed consent
- Patient without clear targets for airflow re-distribution
- Total lung CO uptake (TLCO) \<15% predicted and FEV1 \<15% predicted
- pO2 on air \<6.0kPa
- pCO2 on air \>8.0kPa
- Neurological, rheumatological or other cause of exercise limitation
- Other major medical illness, e.g. lung cancer that will limit participation
- Production of purulent sputum more often than not (more than 50% of days)
- 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 or exercise
- Prednisolone dose greater than 15mg a day
- Significant pulmonary hypertension - RVSP ≥45mmHg
- Left ventricular failure - left ventricular ejection fraction \<45% or left ventricular fraction shortening \<23%
- Prior LVRS or lobectomy
- Lung nodule requiring surgery
- Subject completed or is participating in a standard pulmonary rehabilitation program within 3 months of enrolment
- 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 :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00825578
Start Date
January 1 2009
End Date
December 1 2010
Last Update
February 6 2012
Active Locations (1)
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1
Royal Brompton Hospital
London, United Kingdom, SW3 6NP