Clinical Trial: Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

Brief Summary: The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.

Detailed Summary:
Sponsor: Aeris Therapeutics

Current Primary Outcome: Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 12 Months ]

Change from baseline measurement of FEV1


Original Primary Outcome: Change in Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 6 Months ]

Change from baseline measurment of FEV1 at 6 months post-treatment.


Current Secondary Outcome:

  • Patient Reported Outcomes [ Time Frame: 12 Months ]
    Change in Patient reported outcome from baseline.
  • Exercise Capacity [ Time Frame: 12 months ]
    The change from baseline in Exercise Capacity
  • Radiological Changes [ Time Frame: 12 months ]
    The radiological changes from baseline.


Original Secondary Outcome:

  • Change in FEV1 [ Time Frame: 12 months ]
    Change in FEV1 from baseline measurement at 12 Months post-procedure
  • Change in Forced Vital Capacity (FVC) [ Time Frame: 6 months, 12 months ]
    Change in the FVC from baseline measurement at 6 and 12 months post-procedure
  • Change in 6 Minute Walk Test (6MWT) distance [ Time Frame: 6 months, 12 months ]
    Change in distance walked in 6 minutes from baseline measurement at 6 and 12 months post-procedure.
  • Change in health related quality of life [ Time Frame: 6 months and 12 months ]
    Change in health related quality of life, measure in terms of St. George's Respiratory Questionnaire total domain score from baseline score at 6 and 12 months post-procedure.
  • Change in Residual Volume (RV) [ Time Frame: 6 months and 12 months ]
    Change in RV measurement from baseline at 6 and 12 months post-procedure
  • Change in Residual Volume to Total Lung Capacity (RV/TLC) ratio [ Time Frame: 6 months, 12 months ]
    Change in RV/TLC ratio from baseline at 6 and 12 months post-procedure


Information By: Aeris Therapeutics

Dates:
Date Received: October 6, 2011
Date Started: June 2012
Date Completion:
Last Updated: November 13, 2013
Last Verified: November 2013