A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema

Aeris Therapeutics8 sites in 4 countries55 target enrollmentNovember 2009

ConditionsEmphysema Chronic Obstructive Pulmonary Disease (COPD)Pulmonary Emphysema Lung Diseases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Emphysema
Sponsor: Aeris Therapeutics
Enrollment: 55
Locations: 8
Primary Endpoint: Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Aeris Therapeutics

Responsible Party

Sponsor

Eligibility 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.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio

Time Frame: 12 Weeks following final treatment

Secondary Outcomes

Change from baseline in RV/TLC ratio(24 and 48 weeks following treatment)
Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)(12, 24, 48 weeks following treatment)
Change from baseline in MRC dyspnea score(12, 24, 48 weeks following treatment)
Change from baseline in 6 minute walk test (MWT)(12, 24, 48 weeks following treatment)
Change from baseline in disease-specific health related quality of life assessment (SGRQ)(12, 24, 48 weeks following treatment)