PT  - JOURNAL ARTICLE
AU  - Carolyn Come
AU  - Muhanned Abu-Hijleh
AU  - David Berkowitz
AU  - Michela Bezzi
AU  - Surya Bhatt
AU  - Enrique Cases
AU  - Alexander Chen
AU  - Christopher Cooper
AU  - Gerard Criner
AU  - Mark Dransfield
AU  - Javier Flandes
AU  - Thomas Gildea
AU  - Mark Gotfried
AU  - Kyle Hogarth
AU  - Mordechai Kremer
AU  - William Leeds
AU  - Timothy Liesching
AU  - Charles Marquette
AU  - Richard Mularski
AU  - Victor Pinto-Plata
AU  - Michael Pritchett
AU  - Samaan Rafeq
AU  - Edmundo Rubio
AU  - Dirk-Jan Slebos
AU  - Grigoris Stratakos
AU  - John Walsh
AU  - George Washko
AU  - J. Michael Wells
AU  - Patrick Whitten
AU  - Roger Yusen
AU  - Javier Zulueta
TI  - Results of the ASPIRE endoscopic lung volume reduction trial at study termination
DP  - 2014 Sep 01
TA  - European Respiratory Journal
PG  - P3717
VI  - 44
IP  - Suppl 58
4099  - http://erj.ersjournals.com/content/44/Suppl_58/P3717.short
4100  - http://erj.ersjournals.com/content/44/Suppl_58/P3717.full
SO  - Eur Respir J2014 Sep 01; 44
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.