Title: Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures - a proof of concept study
Funder: Department of Health (England)

Abstract: BACKGROUND - Patients with COPD often remain breathless despite optimum pharmacological therapy. Bronchoscopic lung volume reduction (BLVR) involves placing valves to occlude airways leading to the most affected area of lung causing it to collapse and so improve operating lung volumes and exercise capacity. Response is highly variable but our data suggest that where successful it may lead to a significant survival benefit. A multicentre trial (VENT) has confirmed that valve placement can improve lung function. Mean group benefits were modest because in many patients there is collateral ventilation between the target lobe and adjacent areas of lung meaning that the target area remains inflated. However post hoc analysis of this trial suggested that the benefit in patients with intact interlobar fissures and correct valve placement was similar to that seen in lung volume reduction surgery (LVRS).HYPOTHESIS AND AIMS - The aim of this study is to establish whether an approach treating only the subgroup of patients with intact fissures and the most heterogeneous pattern of disease will lead to a large and consistent benefit.METHODS - A single centre double-blind randomised controlled trial of BLVR aimed to achieve lobar occlusion in COPD selecting only patients with heterogeneous emphysema and intact interlobar fissures. A control group who will receive a sham procedure (bronchoscopy without valve placement). Primary endpoint will be change in FEV1 90 days post-procedure. We will also measure lung volume changes endurance exercise capacity with measurement of dynamic hyperinflation as well as health related quality of life and 6 minute walk distance. 50 patients will be enrolled to have 90% power to detect a 15% difference in FEV1 response between the two study arms ECONOMIC BENEFIT - BLVR is significantly cheaper with fewer complications than LVRS but a reliable estimate of benefit remains to be established. Confirming that a consistent beneficial response can occur in a clearly defined subgroup of patients with COPD will be a significant step forward in management potentially leading to a reduction in long term health-care utilisation.THE TEAM – The advanced COPD service at Royal Brompton Hospital led by dr Hopkinson has considerable expertise in the field of BLVR having published the first trial in The Lancet in 2003. Our multidisciplinary team receives both secondary and tertiary referrals for interventions including LVRS and transpleural airway bypass. The Clinical Trials and Evaluation Unit (CTEU) which is part of the Imperial College Clinical Trials Unit will support the study. Professor Polkey leads the COPD consortium of the NIHR Respiratory BRU at Royal Brompton and Imperial College and dr Pallav Shah is founding chair of the bronchoscopy advisory group for the British Thoracic Society and has enormous interventional bronchoscopy experience. Our patient representative Allan Stone is chair of our local British Lung Foundation Breathe Easy Group. Winston Banya an experienced statistician working with CTEU and the BRU will assist with analysis.


Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RESPIRATORY