Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00207337
Study type Interventional
Source Broncus Technologies
Contact
Status Completed
Phase Phase 2/Phase 3
Start date July 2004
Completion date May 2006

See also
  Status Clinical Trial Phase
Recruiting NCT05825261 - Exploring Novel Biomarkers for Emphysema Detection
Completed NCT02914340 - REACH SVS Control Patient Cross-Over Study N/A
Completed NCT02999685 - Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients N/A
Completed NCT02232841 - Electrical Impedance Imaging of Patients on Mechanical Ventilation N/A
Completed NCT02238327 - Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Withdrawn NCT01908933 - Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema Phase 3
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01710449 - Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen Phase 1
Completed NCT00475007 - Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema N/A
Suspended NCT00523094 - Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure N/A
Recruiting NCT00129350 - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation Phase 1
Completed NCT01953523 - Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions N/A
Completed NCT00000621 - Feasibility of Retinoic Acid Treatment in Emphysema (FORTE) Phase 2
Completed NCT00005292 - Alpha1-antitrypsin Deficiency Registry N/A
Recruiting NCT04537182 - Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema N/A
Active, not recruiting NCT02713347 - Advancing Symptom Alleviation With Palliative Treatment N/A
Recruiting NCT04302272 - STRIVE Post-Market Registry Study
Completed NCT04435327 - Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
Completed NCT03636347 - A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo. Phase 2