Results of the ASPIRE endoscopic lung volume reduction trial at study termination

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 FEV 1 improvement. Secondary endpoints included changes in St. George9s 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. 43% of TG and 16% of CG patients experienced AEs requiring hospitalization (P 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.