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

Phase 2

Completed

• Conditions: Pulmonary Emphysema; COPD; Lung Diseases

• Registration Number: NCT01181466
• Lead Sponsor: Aeris Therapeutics

Brief Summary

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.

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 Timeline

• Study First Submitted: 2010-07-13
• Study Start: 2010-08
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-20
• Last Update Posted: 2011-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Percent Volume of Lung	12 weeks following treatment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The Soroka Medical Center; 🇮🇱 Beer Sheva, Israel

The Rabin Medical Center; 🇮🇱 Petah Tikva, Israel