Trial Information

Summary: The EASE Trial: An investigation of the Exhale® Drug-Eluting Stent in homogeneous emphysema patients with severe hyperinflation

EASE Trial: A Randomized, Double-blind Study to Evaluate the Safety and Effectiveness of the Exhale® Drug-Eluting Stent in Homogeneous Emphysema Subjects with Severe Hyperinflation

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 emphysema.

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.

For more information about airway bypass and the EASE Trial, visit www.theEASEtrial.com

Below are listed some basic eligibility criteria. Study investigators have the complete list of criteria used to qualify participants in the trial.

Inclusion:

• Patients eligible for this study will suffer from severe emphysema in most of both lungs
• Age 35 or older
• Willing to stop smoking at least 8 weeks before entering the trial
• Post-bronchodilator RV/TLC ratio equal to or greater than 0.65
• Post-bronchodilator Forced Expiratory Volume (FEV₁) less than 50% or FEV₁ less than 1 liter

Exclusion:

• Body mass index (BMI) more than 31.1 for men or more than 32.3 for women
• Respiratory infections requiring more than 3 hospitalizations in past year
• Stroke within past 12 months
• Inability to walk more than 140 meters (150 yards) in 6 minutes

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.