ISRCTN04761234CompletedNot Applicable
Bronchoscopic Lung Volume Reduction with endobronchial valves for patients with Heterogeneous emphysema and intact Interlobar FIssures
Imperial College London (UK)0 sites50 target enrollmentStarted: February 29, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Adult patients with stable severe COPD (GOLD stage III or IV with FEV1<50%pred)
- •2. Medical Research Council (MRC) dyspnoea score between 3 and 5
- •3. Total lung capacity (TLC)>100%predicted, residual volume (RV)>150% predicted
- •4. Six minute walk distance of <450m
- •5. Patients will be on optimum medical therapy including inhaled corticosteroids and long acting beta 2 agonist and anti-cholinergic agents unless they are intolerant or decline to use them
- •6. CT thorax must demonstrate heterogeneous emphysema with a defined target lobe with lung destruction and intact adjacent interlobar fissures. Scans will be reviewed by 2 radiologists independently and a third will adjudicate on any disagreements. Radiologists will have to agree that the worst affected lobe of the lung has an emphysema score of >2 (according to the NETT study scoring system), that it is at least 1 point higher than ipsilateral lobes and that it has intact fissures visible on at least one projection
Exclusion Criteria
- •1. Significant co morbidity which limits their exercise capacity or prognosis
- •2. Significant daily sputum production
- •3. Hypoxia (i.e. PO2<6.5Pa)
Investigators
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