EASE Trial: Exhale Airway Stents for Emphysema
- Conditions
- Emphysema
- Interventions
- Device: Sham controlDevice: Exhale® Drug-Eluting Stent
- Registration Number
- NCT00391612
- Lead Sponsor
- Broncus Technologies
- 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 Description
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. Participants in the control group will be finished with the trial after one year. Participants in the treatment group will have a follow-up visit once a year for the next four years to monitor the longer term effects of the airway bypass procedure. This is why the end date of the trial is listed as 2012.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
- High resolution computed tomography (CT) scan evidence of homogeneous emphysema.
- Stopped smoking at least 8 weeks before entering the trial.
- Post-bronchodilator RV/TLC ≥ 0.65.
- Post-bronchodilator Forced Expiratory Volume (FEV1) ≤ 50% or FEV1 < 1 liter.
- Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4.
- Patient has undergone supervised pulmonary rehabilitation of 16-20 sessions over 6-10 weeks.
- Change in FEV1 > 20% pre- and post- bronchodilator measurements or > 200 ml if post-bronchodilator FEV1 < 1 liter.
- Respiratory infections requiring 3 or more hospitalizations in past year.
- Inability to walk > 140 meters (150 yards) in 6 minutes.
- Previous lung volume reduction surgery (LVRS) or lobectomy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Sham control subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy but no stents are placed 1 Exhale® Drug-Eluting Stent subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy during which up to six Exhale drug-eluting stents are placed in the lungs
- Primary Outcome Measures
Name Time Method Forced Vital Capacity (FVC) 6 months modified Medical Research Council (mMRC) score (breathlessness) 6 months
- Secondary Outcome Measures
Name Time Method Residual Volume/Total Lung Capacity (RV/TLC) 6 months Forced Vital Capacity (FVC) 6 months modified Medical Research Council Dyspnea Scale (mMRC) 6 months Forced Expiratory Volume in 1 second (FEV1) 6 months St. George's Respiratory Questionnaire (SGRQ) 6 months 6-minute walk (6MW) 6 months Cycle Ergometry 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. 6 months Residual Volume (RV) 6 months
Trial Locations
- Locations (37)
University of Southern California
🇺🇸Los Angeles, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
International Heart Institute of Montana Foundation
🇺🇸Missoula, Montana, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
UCSF-Fresno
🇺🇸Fresno, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
New York University - Bellevue Hospital
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Pulmonary and Critical Care Associates of Baltimore
🇺🇸Baltimore, Maryland, United States
Santa Casa Hospital
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Topeka Pulmonary/Veritas Clinical Specialties, LTD
🇺🇸Topeka, Kansas, United States
Pulmonary Associates, PA
🇺🇸Phoenix, Arizona, United States
National Jewish Medical and Research Center
🇺🇸Denver, Colorado, United States
Henry Ford Hospital & Medical Center
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Peoria Pulmonary Associates, LTD
🇺🇸Peoria, Illinois, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Emory Healthcare
🇺🇸Atlanta, Georgia, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Sarasota Memorial Health Care System
🇺🇸Sarasota, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Chicago Chest Center at Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Otto Wagner Hospital
🇦🇹Vienna, Austria
Hopital Laval
🇨🇦Quebec, Canada
University Medical Center, Groningen
🇳🇱Groningen, Netherlands
Papworth Hospital
🇬🇧Cambridge, United Kingdom
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Universitatsklinik des Saarlandes
🇩🇪Homburg, Saar, Germany
The Royal Brompton Hospital
🇬🇧London, United Kingdom
Fundación Jiménez Díaz
🇪🇸Madrid, Spain