EASE Trial: Exhale Airway Bypass for Emphysema

Current treatment for emphysema consists of bronchodilators, anti-inflammatory drugs, pulmonary rehabilitation, mechanical breathing assistance, and home oxygen. There is also lung transplant surgery and lung volume reduction surgery. These treatments are not available to all emphysema patients. Treatment for emphysema with the Exhale Airway Bypass is a minimally invasive procedure. This treatment may reduce shortness of breath for patients with severe emphysema. The EASE study tests the safety and effects of Airway Bypass in the treatment of these patients.

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 Hyperinflation

Conditions

• Emphysema

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

Further Details

Emphysema is a serious disease that affects an estimated 60 million people around the world. It causes illness and can result in death. Emphysema causes the destruction of vital inner lung tissues. Without these tissues, air cannot escape normally when a person exhales. Air can be inhaled, but then becomes trapped inside the lung tissue. This happens because the deeper air pathways have become weak and less elastic. The walls of these weakened passages collapse when the patient tries to exhale, and the amount of trapped air grows. This causes over inflation of the lung, or “hyperinflation”. When the lungs are hyperinflated, they can no longer expand and contract properly and the chest begins to expand. The diaphragm (a main breathing muscle that helps the lungs operate even during sleep) becomes flattened and ineffective. This is why the emphysema patients feel a disabling sense of breathlessness called dyspnea. Their lungs are full of air but they can not move it effectively. The dyspnea limits activities of daily living and eventually causes great suffering. The crippling effects of end-stage emphysema include severe dyspnea and severe limitation of activities, illnesses and lung infections and can result in death.

Study Start

May 2006; Expected completion: December 2013

Eligibility & Criteria

• Ages Eligible for Study: 35 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• High resolution computed tomography (CT) scan evidence of homogeneous emphysema.
• DLco > 15% of predicted.
• Post-bronchodilator RV/TLC > 0.69.
• 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.

Exclusion Criteria:

• Change in FEV1 > 20% pre- and post- bronchodilator measurements or > 200 ml if post-bronchodilator FEV1 < 1 liter.
• Respiratory infections requiring > 3 hospitalizations in past year.
• Inability to walk > 140 meters (150 yards) in 6 minutes.
• Giant bulla (> 1/3 volume of lung).
• Previous lung volume reduction surgery (LVRS) or lobectomy.

Total Enrolment

450 (expected)

Contact Details

The Alfred Hospital, Melbourne, Victoria, Australia; Recruiting

• Lynda Holsworth, BNurs +61 (3) 9276 2743 l.holsworth@alfred.org.au
• Tania Dunn +61 (3) 9276 2743 T.Dunn@alfred.org.au

EASE trial website