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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01320566
• Other study ID #: 03-C10-003PLV
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 15, 2011
• Last updated: November 13, 2013
• Start date: March 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• 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 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.

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: Terminated
• Enrollment: 18
• Est. completion date: November 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

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

• Chronic Obstructive Pulmonary Disease(COPD)
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Device:
• AeriSeal System
Not applicable. Follow-Up study only.

Locations

Country	Name	City	State
Israel	The Soroka Medical Center	Beer Sheva
Israel	The Rabin Medical Center	Petach 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 from baseline in Percent Volume of Lung	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.	48 Weeks following treatment	No
Secondary	Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)	Change from baseline at 24 and 48 weeks in RV/TLC	24 and 48 weeks following treatment	No
Secondary	Change in Forced Expiratory Volume in 1 Second (FEV1)	Change from baseline at 24 and 48 weeks in FEV1	24 and 48 weeks following treatment	No
Secondary	Change in Forced Vital Capacity (FVC)	Change from baseline at 24 and 48 weeks in FVC	24 and 48 weeks following treatment	No
Secondary	Change in distance walked in six minutes	Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT)	24 and 48 weeks following treatment	No
Secondary	Change in Medical Research Council Dyspnea (MRCD) score	Change from baseline at 24 and 48 weeks in MRCD score	24 and 48 weeks following treatment	No
Secondary	Change in St. George's Respiratory Questionnaire (SGRQ)domain score	Change from baseline at 24 and 48 weeks in SGRQ total domain score	24 and 48 weeks following treatment	No