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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320566
First Posted: March 22, 2011
Last Update Posted: November 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aeris Therapeutics
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    Change from baseline at 24 and 48 weeks in FEV1

  • Change in Forced Vital Capacity (FVC) [ Time Frame: 24 and 48 weeks following treatment ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT01320566     History of Changes
Other Study ID Numbers: 03-C10-003PLV
First Submitted: March 15, 2011
First Posted: March 22, 2011
Last Update Posted: November 14, 2013
Last Verified: November 2013

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:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Pulmonary Emphysema
Respiratory Tract Diseases
Pathologic Processes