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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

July 13, 2010
October 20, 2011
August 2010
May 2011   (final data collection date for primary outcome measure)
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.
Primary Outcome Measures: [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
CT evidence of lobar volume reduction at site(s) of AeriSeal administration at 12 weejs assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.
Complete list of historical versions of study NCT01181466 on ClinicalTrials.gov Archive Site
  • 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
  • Other efficacy outcome measures: [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in RV/TLC
  • Other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in FEV1
  • other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in FVC
  • Other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change in baseline at 12 weeks in 6 MWT
  • Other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 weeks in MRCD score
  • Other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ]
    Change in baseline at 12 weeks in SGRQ total domain score
Not Provided
Not Provided
 
AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Emphysema
  • COPD
  • Lung Diseases
Device: AeriSeal System
The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2011
May 2011   (final data collection date for primary outcome measure)

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:

-

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01181466
03-C10-002PLV
Yes
Aeris Therapeutics
Aeris Therapeutics
Not Provided
Not Provided
Aeris Therapeutics
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP