NCT01449292

Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Aeris Therapeutics · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.

Conditions

• Pulmonary Emphysema

Interventions

Type	Name	Description
DEVICE	Treatment plus Optimal Medical Therapy	Patients will be treated with the AeriSeal System in 2 subsegments in the upper lobes of each lung (4 subsegments total). 20mL of foam sealant will be injected via catheter into each subsegment selected for treatment. Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
OTHER	Optimal Medical Therapy	Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-10-10
• Last updated: 2013-11-14

Locations

40 sites across 7 countries: United States, France, Greece, Israel, Italy, Netherlands, Spain