Exhale (R) Stent for Emphysema
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Current treatment for emphysema is limited to measures that include inhaled oxygen,
      bronchodilators, anti-inflammatory drugs and pulmonary rehabilitation. Highly invasive
      procedures such as lung volume reduction surgery or lung transplantation are also performed.
      Treatment using the Exhale Drug-Eluting Stent (DES) is a minimally invasive bronchoscopic
      treatment that has the potential to reduce shortness of breath in emphysema patients. This
      study tests the safety and effects of Exhale DES in the treatment of patients with emphysema.
    

Detailed description: 
      Emphysema affects an estimated 60 million people worldwide and is a major cause of morbidity
      and mortality. In its most basic terms, emphysema causes the destruction of lung parenchyma
      resulting in collateral ventilation from one part of the lung to another through the
      disrupted alveolar walls, to the point that gas transport from one part of the lung to
      another may exceed gas flow through the small airways. In other words, the gas can move
      freely about within the lung, but it cannot get out, which causes over inflation, or
      hyperinflation of the diseased lung. When the disease is far advanced, patients are afflicted
      with disabling dyspnea that progressively restricts their activities and eventually causes
      great suffering. The crippling effects of end-stage emphysema, including severe dyspnea and
      marked limitation of activities, relate in large measure to the dynamic hyperinflation of the
      lungs associated with the loss of elasticity, gas trapping and collapse of small airways. The
      progressive enlargement of the thorax and flattening of the diaphragm render inspiratory
      muscles inefficient, increase the work of breathing and contribute to a feeling of
      breathlessness. The major medical therapeutic modalities include bronchodilator and
      anti-inflammatory drugs directed at decreasing airway resistance and antibiotics to combat
      infection. Pulmonary rehabilitation techniques and exercise training have proven of
      palliative benefit. In general, the results of medical treatment for advanced airway
      obstruction frequently result in a persistently anguished patient and frustrated physician. A
      system that could efficiently decompress emphysematous lungs with each breath would result in
      significant clinical benefit, including lessened dyspnea, decreased work of breathing, and
      increased exercise tolerance.

      In addition to medical therapies, there are two surgical therapies available to emphysema
      sufferers: Lung transplantation and Lung Volume Reduction Surgery (LVRS). In the National
      Emphysema Treatment Trial (NETT), LVRS was shown to be effective in a sub-set of emphysema
      patients, but it had the drawback of increased short-term mortality as compared to the
      medical control arm. This was likely due to the invasiveness of LVRS.

      Lung transplantation is a widely accepted surgical treatment for emphysema; however it is an
      unrealistic option for most patients. The selection criteria are very stringent for
      acceptance to receive a donor lung(s). Lung transplantation carries a high long-term
      morbidity and mortality and is severely limited by the shortage of available donor lungs.

      We seek to take advantage of collateral ventilation seen in advanced emphysema by creating
      passageways from the lung parenchyma to large airways, through which air can escape the lungs
      during exhalation. The Exhale therapeutic intervention should be applicable to the majority
      of emphysema patients who suffer from hyperinflation of their lungs. It would be desirable to
      have a therapeutic option that is both less invasive and more readily available to emphysema
      sufferers. We have been working on such a therapy and have begun to investigate it in the
      clinic.
    

Intervention name(s): Exhale Drug-Eluting Stent
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD (Chronic Obstructive Pulmonary Disease); Emphysema; Minimally invasive