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

Primary Purpose

Pulmonary Emphysema, COPD, Lung Diseases

Status

Completed

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 PLVR, BLVR, AeriSeal, treatment, device, breathing, COPD, emphysema, polymeric lung volume reduction, biologic lung volume reduction, 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 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:

Sites / Locations

The Soroka Medical Center
The Rabin Medical Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Change from baseline at 12 weeks in RV/TLC

Change in Forced Expiratory Volume in 1 Second (FEV1)

Change from baseline at 12 weeks in FEV1

Change in Forced Vital Capacity (FVC)

Change from baseline at 12 weeks in FVC

Change in distance walked in six minutes

Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT)

Change in Medical Research Council Dyspnea (MRCD) score

Change from baseline at 12 weeks in MRCD score

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

Change from baseline at 12 weeks in SGRQ total domain score

Full Information

NCT ID

NCT01181466

First Posted

July 13, 2010

Last Updated

October 20, 2011

Sponsor

Aeris Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01181466

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (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 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.

6. Conditions and Keywords

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

Pulmonary Emphysema, COPD, Lung Diseases

Keywords

PLVR, BLVR, AeriSeal, treatment, device, breathing, COPD, emphysema, polymeric lung volume reduction, biologic lung volume reduction, 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

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

AeriSeal System

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Percent Volume of Lung

Description

Time Frame

12 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 12 weeks in RV/TLC

Time Frame

12 weeks following treatment

Title

Change in Forced Expiratory Volume in 1 Second (FEV1)

Description

Change from baseline at 12 weeks in FEV1

Time Frame

12 weeks following treatment

Title

Change in Forced Vital Capacity (FVC)

Description

Change from baseline at 12 weeks in FVC

Time Frame

12 weeks following treatment

Title

Change in distance walked in six minutes

Description

Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT)

Time Frame

12 weeks following treatment

Title

Change in Medical Research Council Dyspnea (MRCD) score

Description

Change from baseline at 12 weeks in MRCD score

Time Frame

12 weeks following treatment

Title

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

Description

Change from baseline at 12 weeks in SGRQ total domain score

Time Frame

12 weeks following treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Facility Information:

Facility Name

The Soroka Medical Center

City

Beer Sheva

Country

Israel

Facility Name

The Rabin Medical Center

City

Petah Tikva

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

22374920

Citation

Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.

Results Reference

derived

Links:

URL

http://www.aerist.com/

Description

Aeris Therapeutics

Learn more about this trial

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

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