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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01181466
First received: July 13, 2010
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Pulmonary Emphysema
COPD
Lung Diseases
Device: AeriSeal System
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Change in Percent Volume of Lung [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in RV/TLC

  • Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in FEV1

  • Change in Forced Vital Capacity (FVC) [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in FVC

  • Change in distance walked in six minutes [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT)

  • Change in Medical Research Council Dyspnea (MRCD) score [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in MRCD score

  • Change in St. George's Respiratory Questionnaire (SGRQ) domain score [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in SGRQ total domain score


Enrollment: 20
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AeriSeal System
    The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181466

Locations
Israel
The Soroka Medical Center
Beer Sheva, Israel
The Rabin Medical Center
Petah Tikva, Israel
Sponsors and Collaborators
Aeris Therapeutics
  More Information

Additional Information:
No publications provided by Aeris Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT01181466     History of Changes
Other Study ID Numbers: 03-C10-002PLV
Study First Received: July 13, 2010
Last Updated: October 20, 2011
Health Authority: Israel: Ministry of Health
Israel: Ethics Commission

Keywords provided by Aeris Therapeutics:
emphysema
PLVR
BLVR
AeriSeal
treatment
device
breathing
COPD
polymeric lung volume reduction
biologic lung volume reduction
heterogeneous
homogeneous
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Pathologic Processes
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014