RT Journal Article
SR Electronic
T1 Results of the ASPIRE endoscopic lung volume reduction trial at study termination
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P3717
VO 44
IS Suppl 58
A1 Carolyn Come
A1 Muhanned Abu-Hijleh
A1 David Berkowitz
A1 Michela Bezzi
A1 Surya Bhatt
A1 Enrique Cases
A1 Alexander Chen
A1 Christopher Cooper
A1 Gerard Criner
A1 Mark Dransfield
A1 Javier Flandes
A1 Thomas Gildea
A1 Mark Gotfried
A1 Kyle Hogarth
A1 Mordechai Kremer
A1 William Leeds
A1 Timothy Liesching
A1 Charles Marquette
A1 Richard Mularski
A1 Victor Pinto-Plata
A1 Michael Pritchett
A1 Samaan Rafeq
A1 Edmundo Rubio
A1 Dirk-Jan Slebos
A1 Grigoris Stratakos
A1 John Walsh
A1 George Washko
A1 J. Michael Wells
A1 Patrick Whitten
A1 Roger Yusen
A1 Javier Zulueta
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P3717.abstract
AB BACKGROUND: ASPIRE, a multicenter randomized controlled trial to evaluate AeriSeal System endoscopic lung volume reduction (LVR) for advanced upper lobe predominant emphysema, was conducted from 9/2012-11/2013. It was terminated for non-regulatory reasons after 95/300 patients were randomized.AIM/METHODS: ASPIRE compared AeriSeal Lung Sealant therapy plus medical treatment to medical treatment alone with a 3:2 randomization and planned 3, 6, 9, and 12 month follow-up. The primary endpoint was 12 month FEV1 improvement. Secondary endpoints included changes in St. George's Respiratory Questionnaire (SGRQ), Medical Research Council Dyspnea score (MRCD), and 6-minute walk test (6MWT). Subjects underwent pulmonary rehabilitation.RESULTS: At termination, safety data were available for 90 patients. Efficacy results were available at 3 months for 57 patients (34 treatment group, TG; 23 control group, CG) and at 6 months for 32 patients (19 TG, 13 CG). Improvements at 3 months persisted at 6 months.View this table:43% of TG and 16% of CG patients experienced AEs requiring hospitalization (P<0.05); the majority were respiratory (39% TG vs. 15% CG). There were 2 deaths in the TG (1 treatment-related); none in the CG.CONCLUSION: Interim results confirm prior open label studies showing hydrogel-based LVR improves physiology and patient reported outcomes compared to optimal medical therapy in patients with advanced emphysema, but with increased AE risk requiring hospitalization.