EASE Trial: Exhale Airway Stents for Emphysema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Broncus Technologies.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Broncus Technologies
ClinicalTrials.gov Identifier:
NCT00391612
First received: October 20, 2006
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Emphysema
Device: Exhale® Drug-Eluting Stent
Device: Sham control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Broncus Technologies:

Primary Outcome Measures:
  • Forced Vital Capacity (FVC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • modified Medical Research Council (mMRC) score (breathlessness) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Residual Volume/Total Lung Capacity (RV/TLC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Forced Vital Capacity (FVC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • modified Medical Research Council Dyspnea Scale (mMRC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 6-minute walk (6MW) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cycle Ergometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Residual Volume (RV) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: May 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00391612

  Show 37 Study Locations
Sponsors and Collaborators
Broncus Technologies
Investigators
Principal Investigator: Joel D. Cooper, MD, FACS, FRCS
Principal Investigator: Gerhard W. Sybrecht, Prof. Dr. med. Universitätskliniken des Saarlandes
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Isaac, Senior Vice President, Clinical and Regulatory Affairs and Quality Assurance, Broncus Technologies, Inc
ClinicalTrials.gov Identifier: NCT00391612     History of Changes
Other Study ID Numbers: Protocol 30
Study First Received: October 20, 2006
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Austria: Ethikkommission
Austria: Federal Ministry for Health and Women
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on July 24, 2014