Clinical Trial: EASE Trial: Exhale Airway Stents for Emphysema

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Double-blind Study to Evaluate the Safety and Effectiveness of the Exhale® Drug-Eluting Stent in Homogeneous Emphysema Subjects With Severe Hyperinflati

Brief Summary: This is an international clinical research study evaluating the safety and effectiveness of a new procedure called airway bypass. The goal of this research is to see if airway bypass can relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and reducing shortness of breath in patients with severe homogeneous (diffuse) emphysema. "EASE" stands for Exhale Airway Stents for Emphysema.

Detailed Summary:

Over 3 million people in the United States and tens of millions more throughout the world live with emphysema, a chronic, progressive, irreversible disease of the lungs. The hallmark of emphysema is hyperinflation of the lungs -- air is trapped in the lungs and cannot escape, causing the lungs to become larger and larger. This makes it difficult to breathe and dyspnea (shortness of breath) is the result.

The airway bypass procedure is performed using a bronchoscope with the patient under anesthesia. Very small passageways are created between the damaged lung tissue and the larger breathing passages (airways). Small stents are inserted to keep the new pathways from closing. These pathways could potentially provide a way for the trapped air to escape when the patient exhales. If the amount of air trapped in the lungs is reduced then it should be easier for the person to breathe.

The EASE study will compare the effects of Exhale Drug-Eluting Stents in patients to a sham-control group of patients who do not receive the stents. Two out of three (2/3) of the participants in the trial will be in the airway bypass group, or "treatment" group. Participants in the treatment group will undergo the airway bypass procedure with up to six drug-eluting stents implanted in their lungs, creating the passageways for the trapped air to escape. A smaller group - one out of three (1/3) participants - will be the "control" group. The control group will have bronchoscopy, but passages will not be made and stents will not be implanted.

Participants will need to return to the study center four times during the year for follow-up visits and tests. All participants will be told which group they were in when they come back for a follow-up visit one year after the procedure. Partici
Sponsor: Broncus Technologies

Current Primary Outcome:

  • Forced Vital Capacity (FVC) [ Time Frame: 6 months ]
  • modified Medical Research Council (mMRC) score (breathlessness) [ Time Frame: 6 months ]


Original Primary Outcome:

  • FVC
  • mMRC.


Current Secondary Outcome:

  • Residual Volume/Total Lung Capacity (RV/TLC) [ Time Frame: 6 months ]
  • Forced Vital Capacity (FVC) [ Time Frame: 6 months ]
  • modified Medical Research Council Dyspnea Scale (mMRC) [ Time Frame: 6 months ]
  • Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 6 months ]
  • St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 6 months ]
  • 6-minute walk (6MW) [ Time Frame: 6 months ]
  • Cycle Ergometry [ Time Frame: 6 months ]
  • Note: Residual Volume/Total Lung Capacity (RV/TLC) will be analyzed for superiority. All other secondary endpoints will be analyzed for informational purposes. [ Time Frame: 6 months ]
  • Residual Volume (RV) [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Residual Volume/Total Lung Capacity (RV/TLC)
  • Residual Volume (RV)
  • Forced Vital Capacity (FVC)
  • modified Medical Research Council Dyspnea Scale (mMRC)
  • Forced Expiratory Volume in 1 second (FEV1)
  • St. George's Respiratory Questionnaire (SGRQ)
  • 6-minute walk (6MW)
  • Cycle Ergometry
  • Note: Residual Volume/Total Lung Capacity (RV/TLC) will be analyzed for superiority. All other secondary endpoints will be analyzed for informational purposes.


Information By: Broncus Technologies

Dates:
Date Received: October 20, 2006
Date Started: May 2006
Date Completion: December 2013
Last Updated: January 10, 2011
Last Verified: January 2011