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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2011

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Change in Percent Volume of Lung
    • Time Frame: 12 weeks following treatment
    • 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 Measures

  • Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)
    • Time Frame: 12 weeks following treatment
    • Change from baseline at 12 weeks in RV/TLC
  • Change in Forced Expiratory Volume in 1 Second (FEV1)
    • Time Frame: 12 weeks following treatment
    • Change from baseline at 12 weeks in FEV1
  • Change in Forced Vital Capacity (FVC)
    • Time Frame: 12 weeks following treatment
    • Change from baseline at 12 weeks in FVC
  • Change in distance walked in six minutes
    • Time Frame: 12 weeks following treatment
    • 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
    • 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
    • Change from baseline at 12 weeks in SGRQ total domain score

Participating in This Clinical Trial

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:

-

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aeris Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor

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