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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01320566
First received: March 15, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Emphysema
Chronic Obstructive Pulmonary Disease(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 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

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Change from baseline in Percent Volume of Lung [ Time Frame: 48 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 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) [ Time Frame: 24 and 48 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 24 and 48 weeks in RV/TLC

  • Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 24 and 48 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 24 and 48 weeks in FEV1

  • Change in Forced Vital Capacity (FVC) [ Time Frame: 24 and 48 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 24 and 48 weeks in FVC

  • Change in distance walked in six minutes [ Time Frame: 24 and 48 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT)

  • Change in Medical Research Council Dyspnea (MRCD) score [ Time Frame: 24 and 48 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 24 and 48 weeks in MRCD score

  • Change in St. George's Respiratory Questionnaire (SGRQ)domain score [ Time Frame: 24 and 48 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 24 and 48 weeks in SGRQ total domain score


Estimated Enrollment: 18
Study Start Date: March 2011
Study Completion Date: November 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AeriSeal System
    Not applicable. Follow-Up study only.
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 been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.
  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: NCT01320566

Locations
Israel
The Soroka Medical Center
Beer Sheva, Israel, 84101
The Rabin Medical Center
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Aeris Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT01320566     History of Changes
Other Study ID Numbers: 03-C10-003PLV
Study First Received: March 15, 2011
Last Updated: November 13, 2013
Health Authority: Israel: Ministry of Health
Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on July 22, 2014