Emphysema Clinical Trial
Official title:
A Prospective Feasibility Study to Evaluate the Safety and Performance of the Exhale(R) Drug-Eluting Stent System in Patients With Emphysema
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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