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EASE Trial: Exhale Airway Stents for Emphysema (EASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00391612
Recruitment Status : Unknown
Verified January 2011 by Broncus Technologies.
Recruitment status was:  Active, not recruiting
First Posted : October 24, 2006
Last Update Posted : January 12, 2011
Information provided by:
Broncus Technologies

Brief Summary:
This is an international clinical research study evaluating the safety and effectiveness of a new procedure called airway bypass. The goal of this research is to see if airway bypass can relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and reducing shortness of breath in patients with severe homogeneous (diffuse) emphysema. "EASE" stands for Exhale Airway Stents for Emphysema.

Condition or disease Intervention/treatment Phase
Emphysema Device: Exhale® Drug-Eluting Stent Device: Sham control Phase 3

Detailed Description:

Over 3 million people in the United States and tens of millions more throughout the world live with emphysema, a chronic, progressive, irreversible disease of the lungs. The hallmark of emphysema is hyperinflation of the lungs -- air is trapped in the lungs and cannot escape, causing the lungs to become larger and larger. This makes it difficult to breathe and dyspnea (shortness of breath) is the result.

The airway bypass procedure is performed using a bronchoscope with the patient under anesthesia. Very small passageways are created between the damaged lung tissue and the larger breathing passages (airways). Small stents are inserted to keep the new pathways from closing. These pathways could potentially provide a way for the trapped air to escape when the patient exhales. If the amount of air trapped in the lungs is reduced then it should be easier for the person to breathe.

The EASE study will compare the effects of Exhale Drug-Eluting Stents in patients to a sham-control group of patients who do not receive the stents. Two out of three (2/3) of the participants in the trial will be in the airway bypass group, or "treatment" group. Participants in the treatment group will undergo the airway bypass procedure with up to six drug-eluting stents implanted in their lungs, creating the passageways for the trapped air to escape. A smaller group - one out of three (1/3) participants - will be the "control" group. The control group will have bronchoscopy, but passages will not be made and stents will not be implanted.

Participants will need to return to the study center four times during the year for follow-up visits and tests. All participants will be told which group they were in when they come back for a follow-up visit one year after the procedure. Participants in the control group will be finished with the trial after one year. Participants in the treatment group will have a follow-up visit once a year for the next four years to monitor the longer term effects of the airway bypass procedure. This is why the end date of the trial is listed as 2012.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2006
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Sham Comparator: 2
subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy but no stents are placed
Device: Sham control
5-10 minute bronchoscopic procedure in which the lungs are examined and a bronchial lavage is performed; the bronchoscope is then retracted to a point above the carina and below the vocal folds for the remained of the time; total procedure time is about 1-2 hours

Experimental: 1
subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy during which up to six Exhale drug-eluting stents are placed in the lungs
Device: Exhale® Drug-Eluting Stent
Bronchoscopic procedure in which up to six Exhale Drug-Eluting Stents are placed in the lungs; total procedure time is 1 to 2 hours

Primary Outcome Measures :
  1. Forced Vital Capacity (FVC) [ Time Frame: 6 months ]
  2. modified Medical Research Council (mMRC) score (breathlessness) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Residual Volume/Total Lung Capacity (RV/TLC) [ Time Frame: 6 months ]
  2. Forced Vital Capacity (FVC) [ Time Frame: 6 months ]
  3. modified Medical Research Council Dyspnea Scale (mMRC) [ Time Frame: 6 months ]
  4. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 6 months ]
  5. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 6 months ]
  6. 6-minute walk (6MW) [ Time Frame: 6 months ]
  7. Cycle Ergometry [ Time Frame: 6 months ]
  8. Note: Residual Volume/Total Lung Capacity (RV/TLC) will be analyzed for superiority. All other secondary endpoints will be analyzed for informational purposes. [ Time Frame: 6 months ]
  9. Residual Volume (RV) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. High resolution computed tomography (CT) scan evidence of homogeneous emphysema.
  2. Stopped smoking at least 8 weeks before entering the trial.
  3. Post-bronchodilator RV/TLC ≥ 0.65.
  4. Post-bronchodilator Forced Expiratory Volume (FEV1) ≤ 50% or FEV1 < 1 liter.
  5. Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4.
  6. Patient has undergone supervised pulmonary rehabilitation of 16-20 sessions over 6-10 weeks.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00391612

Show Show 37 study locations
Sponsors and Collaborators
Broncus Technologies
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Principal Investigator: Joel D. Cooper, MD, FACS, FRCS
Principal Investigator: Gerhard W. Sybrecht, Prof. Dr. med. Universitätskliniken des Saarlandes
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nancy Isaac, Senior Vice President, Clinical and Regulatory Affairs and Quality Assurance, Broncus Technologies, Inc Identifier: NCT00391612    
Other Study ID Numbers: Protocol 30
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: January 2011
Keywords provided by Broncus Technologies:
COPD (Chronic Obstructive Pulmonary Disease)
Minimally Invasive
Additional relevant MeSH terms:
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Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases