AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema

A Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema

The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Pulmonary Emphysema; COPD
• Intervention / Treatment: Device: AeriSeal System

Detailed Description

Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come.

The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Israel
  • Beer Sheva, Israel
    • The Soroka Medical Center
  • Petah Tikva, Israel
    • The Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Percent Volume of Lung	Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 12 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.	12 weeks following treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)	Change from baseline at 12 weeks in RV/TLC	12 weeks following treatment
Change in Forced Expiratory Volume in 1 Second (FEV1)	Change from baseline at 12 weeks in FEV1	12 weeks following treatment
Change in Forced Vital Capacity (FVC)	Change from baseline at 12 weeks in FVC	12 weeks following treatment
Change in distance walked in six minutes	Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT)	12 weeks following treatment
Change in Medical Research Council Dyspnea (MRCD) score	Change from baseline at 12 weeks in MRCD score	12 weeks following treatment
Change in St. George's Respiratory Questionnaire (SGRQ) domain score	Change from baseline at 12 weeks in SGRQ total domain score	12 weeks following treatment

Collaborators and Investigators

• Sponsor: Aeris Therapeutics

Publications and helpful links

General Publications

• Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.

Helpful Links

• Aeris Therapeutics

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 21, 2011
• Last Update Submitted That Met QC Criteria: October 20, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: treatment; Respiratory Tract Diseases; Pathologic Processes; breathing; COPD; Lung Diseases; device; Pulmonary Disease, Chronic Obstructive; emphysema; PLVR; AeriSeal; polymeric lung volume reduction; heterogeneous; homogeneous; BLVR; biologic lung volume reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 03-C10-002PLV