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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

Primary Purpose

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

Status

Terminated

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

AeriSeal System

About this trial

This is an interventional treatment trial for Pulmonary Emphysema focused on measuring Polymeric Lung Volume Reduction (PLVR), Bolilogic Lung Volume Reduction (BLVR), AeriSeal, treatment, device, breathing, COPD, emphysema, heterogeneous, homogeneous, Pathologic Processes, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Soroka Medical Center
The Rabin Medical Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)

Change from baseline at 24 and 48 weeks in RV/TLC

Change in Forced Expiratory Volume in 1 Second (FEV1)

Change from baseline at 24 and 48 weeks in FEV1

Change in Forced Vital Capacity (FVC)

Change from baseline at 24 and 48 weeks in FVC

Change in distance walked in six minutes

Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT)

Change in Medical Research Council Dyspnea (MRCD) score

Change from baseline at 24 and 48 weeks in MRCD score

Change in St. George's Respiratory Questionnaire (SGRQ)domain score

Change from baseline at 24 and 48 weeks in SGRQ total domain score

Full Information

NCT ID

NCT01320566

First Posted

March 15, 2011

Last Updated

November 13, 2013

Sponsor

Aeris Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01320566

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Terminated

Study Start Date

March 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aeris Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Polymeric Lung Volume Reduction (PLVR), Bolilogic Lung Volume Reduction (BLVR), AeriSeal, treatment, device, breathing, COPD, emphysema, heterogeneous, homogeneous, Pathologic Processes, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

AeriSeal System

Intervention Description

Not applicable. Follow-Up study only.

Primary Outcome Measure Information:

Title

Change from baseline in Percent Volume of Lung

Description

Time Frame

48 Weeks following treatment

Secondary Outcome Measure Information:

Title

Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)

Description

Change from baseline at 24 and 48 weeks in RV/TLC

Time Frame