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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181466
• Other study ID #: 03-C10-002PLV
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 13, 2010
• Last updated: October 20, 2011
• Start date: August 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthIsrael: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Emphysema
• Lung Diseases
• Pulmonary Emphysema

Intervention

Device:
• AeriSeal System
The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.

Locations

Country	Name	City	State
Israel	The Soroka Medical Center	Beer Sheva
Israel	The Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change in Forced Expiratory Volume in 1 Second (FEV1)	Change from baseline at 12 weeks in FEV1	12 weeks following treatment	No
Secondary	Change in Forced Vital Capacity (FVC)	Change from baseline at 12 weeks in FVC	12 weeks following treatment	No
Secondary	Change in distance walked in six minutes	Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT)	12 weeks following treatment	No
Secondary	Change in Medical Research Council Dyspnea (MRCD) score	Change from baseline at 12 weeks in MRCD score	12 weeks following treatment	No
Secondary	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	No