PT  - JOURNAL ARTICLE
AU  - Claire Davey
AU  - Zaid Zoumot
AU  - William McNulty
AU  - Simon Jordan
AU  - Denis Carr
AU  - Michael Rubens
AU  - David Hansell
AU  - Michael Polkey
AU  - Pallav Shah
AU  - Nicholas Hopkinson
TI  - Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (BeLieVeR-HIFi)
DP  - 2014 Sep 01
TA  - European Respiratory Journal
PG  - 1773
VI  - 44
IP  - Suppl 58
4099  - http://erj.ersjournals.com/content/44/Suppl_58/1773.short
4100  - http://erj.ersjournals.com/content/44/Suppl_58/1773.full
SO  - Eur Respir J2014 Sep 01; 44
AB  - BackgroundEndobronchial valve (EBV) placement for patients with emphysema is effective in some individuals but overall group responses have been modest in clinical trials. We evaluated whether prospectively selecting patients with heterogeneous emphysema and intact interlobar fissures could improve outcomes.The trial was supported by the NIHR EME program and registered (ISRCTN04761234).MethodA double-blind randomised controlled trial comparing complete lobar occlusion with EBV against sham bronchoscopy.Inclusion:(1) GOLD III or IV COPD with hyperinflation (TLC>100% & RV>150%) and limited exercise capacity (6 minute walk (6MW) <450m) (2) Heterogeneous emphysema and intact interlobar fissures CT thorax.Primary endpoint was change in FEV1 at 3 months.Results50 participants were randomised. Participants were well matched at baseline.View this table:Baseline CharacteristicsThere were 2 deaths in the treatment arm (not related to EBV placement) and 1 patient in the control arm missed their final visit (in hospital with spontaneous pneumonthorax). Values for these 3 subjects were imputed.View this table:Lung Function OutcomesConclusionThis is the first prospective double-blind, randomised controlled trial of bronchoscopic therapy for emphysema to demonstrate clinically significant improvements in lung function.