EASE Trial: Exhale Airway Stents for Emphysema

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Emphysema

In brief

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.

Key facts

Study ID

NCT00391612

Run by

Broncus Technologies

People needed

450

Starts

2006-05-01

Expected to finish

2013-12-01

Last updated by the study team

2011-01-12

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pulmonary Associates, PA — Phoenix, Arizona, United States
• UCSF-Fresno — Fresno, California, United States
• University of Southern California — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Sarasota Memorial Health Care System — Sarasota, Florida, United States
• Emory Healthcare — Atlanta, Georgia, United States
• Peoria Pulmonary Associates, LTD — Peoria, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Chicago Chest Center at Central DuPage Hospital — Winfield, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Topeka Pulmonary/Veritas Clinical Specialties, LTD — Topeka, Kansas, United States
• Pulmonary and Critical Care Associates of Baltimore — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital & Medical Center — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• International Heart Institute of Montana Foundation — Missoula, Montana, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• New York University - Bellevue Hospital — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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