Trial record 14 of 275 for:    "Emphysema"

Exhale (R) Stent for Emphysema

This study has been completed.
Sponsor:
Information provided by:
Broncus Technologies
ClinicalTrials.gov Identifier:
NCT00207337
First received: September 12, 2005
Last updated: January 21, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Emphysema
Device: Exhale Drug-Eluting Stent
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Broncus Technologies:

Primary Outcome Measures:
  • Procedural and technical success - operatively
  • Decrease in residual volume > 300mL from baseline
  • Safety

Secondary Outcome Measures:
  • Dyspnea scoring
  • Pulmonary function measures
  • Exercise tolerance
  • Quality of life measures

Estimated Enrollment: 60
Study Start Date: July 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. High resolution computed tomography (CT) scan evidence of bilateral emphysema
  2. Residual volume (RV) ≥ 220% predicted.
  3. Total lung capacity (TLC) ≥ 133% of predicted value.
  4. Forced expiratory volume (FEV1) < 40% of predicted or FEV1 < 1 liter.
  5. Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4.
  6. Patient has undergone pulmonary rehabilitation of 16 - 20 sessions.

Exclusion Criteria:

  1. FEV1 > 20%
  2. Diffusing capacity for carbon monoxide (DLco) < 15% of predicted.
  3. Respiratory infection requiring > 3 hospitalizations in past year
  4. Inability to walk > 140 meters in 6 minutes
  5. Giant bulla > 1/3 of one lung's volume
  6. Previous lung volume reduction surgery (LVRS) or lobectomy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207337

Locations
Australia, Queensland
The Prince Charles Hospital
Rode Road, Chermside, Queensland, Australia, 4032
Australia, Victoria
The Alfred Hospital
Prahran, Victoria, Australia, 3181
Australia
Concord Repatriation General Hospital
Burwood, Australia, 2134
Brazil
Irmandade Santa Casa de Misericordia
Porto Alegre, Brazil, 90020-090
Germany
Universitätsklinik des Saarlandes
Homburg, Saarland, Germany, 66421
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Broncus Technologies
Investigators
Principal Investigator: Gregory I. Snell, MD The Alfred Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00207337     History of Changes
Other Study ID Numbers: 0304-28
Study First Received: September 12, 2005
Last Updated: January 21, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Broncus Technologies:
COPD (Chronic Obstructive Pulmonary Disease)
Emphysema
Minimally invasive

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014