A Continuation 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

Phase 2

Terminated

• Conditions: Pulmonary Emphysema; Chronic Obstructive Pulmonary Disease(COPD); Lung Diseases

• Registration Number: NCT01320566
• Lead Sponsor: Aeris Therapeutics

Brief Summary

The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.

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 Start: 2011-03
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2012-01
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Patients must have been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in Percent Volume of Lung	48 Weeks following treatment	Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 48 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 Forced Expiratory Volume in 1 Second (FEV1)	24 and 48 weeks following treatment	Change from baseline at 24 and 48 weeks in FEV1
Change in distance walked in six minutes	24 and 48 weeks following treatment	Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT)
Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)	24 and 48 weeks following treatment	Change from baseline at 24 and 48 weeks in RV/TLC
Change in Forced Vital Capacity (FVC)	24 and 48 weeks following treatment	Change from baseline at 24 and 48 weeks in FVC
Change in St. George's Respiratory Questionnaire (SGRQ)domain score	24 and 48 weeks following treatment	Change from baseline at 24 and 48 weeks in SGRQ total domain score
Change in Medical Research Council Dyspnea (MRCD) score	24 and 48 weeks following treatment	Change from baseline at 24 and 48 weeks in MRCD score

Trial Locations

Locations (2)

The Rabin Medical Center; 🇮🇱 Petach Tikva, Israel

The Soroka Medical Center; 🇮🇱 Beer Sheva, Israel