AeriSeal System for Lung Volume Reduction

Aeris Therapeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

Lung Diseases

Pulmonary Emphysema

Emphysema

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Device: AeriSeal System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01051258

03-C10-001PLV

03-C08-003PLVGP4-5

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.

Full description

The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.

Enrollment

55 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% predicted, and RV > 135% predicted.
Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.