Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
450 participants
INTERVENTIONAL
2006-05-31
2013-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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2
subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy but no stents are placed
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
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
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
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.
35 Years
ALL
No
Sponsors
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Broncus Technologies
INDUSTRY
Responsible Party
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Broncus Technologies, Inc
Principal Investigators
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Joel D. Cooper, MD, FACS, FRCS
Role: PRINCIPAL_INVESTIGATOR
Gerhard W. Sybrecht, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Universitätskliniken des Saarlandes
Locations
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Pulmonary Associates, PA
Phoenix, Arizona, United States
UCSF-Fresno
Fresno, California, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Sarasota Memorial Health Care System
Sarasota, Florida, United States
Emory Healthcare
Atlanta, Georgia, United States
Peoria Pulmonary Associates, LTD
Peoria, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Chicago Chest Center at Central DuPage Hospital
Winfield, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Topeka Pulmonary/Veritas Clinical Specialties, LTD
Topeka, Kansas, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital & Medical Center
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
International Heart Institute of Montana Foundation
Missoula, Montana, United States
New York Methodist Hospital
Brooklyn, New York, United States
New York University - Bellevue Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
The Alfred Hospital
Melbourne, Victoria, Australia
Otto Wagner Hospital
Vienna, , Austria
Santa Casa Hospital
Porto Alegre, Rio Grande do Sul, Brazil
London Health Sciences Centre
London, Ontario, Canada
Hopital Laval
Québec, Quebec, Canada
Universitatsklinik des Saarlandes
Homburg, Saarland, Germany
Mater Misericordiae University Hospital
Dublin, , Ireland
University Medical Center, Groningen
Groningen, , Netherlands
Fundación Jiménez Díaz
Madrid, , Spain
Papworth Hospital
Cambridge, , United Kingdom
The Royal Brompton Hospital
London, , United Kingdom
Countries
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References
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Lausberg HF, Chino K, Patterson GA, Meyers BF, Toeniskoetter PD, Cooper JD. Bronchial fenestration improves expiratory flow in emphysematous human lungs. Ann Thorac Surg. 2003 Feb;75(2):393-7; discussion 398. doi: 10.1016/s0003-4975(02)04553-8.
Rendina EA, De Giacomo T, Venuta F, Coloni GF, Meyers BF, Patterson GA, Cooper JD. Feasibility and safety of the airway bypass procedure for patients with emphysema. J Thorac Cardiovasc Surg. 2003 Jun;125(6):1294-9. doi: 10.1016/s0022-5223(02)73243-1.
Choong CK, Haddad FJ, Gee EY, Cooper JD. Feasibility and safety of airway bypass stent placement and influence of topical mitomycin C on stent patency. J Thorac Cardiovasc Surg. 2005 Mar;129(3):632-8. doi: 10.1016/j.jtcvs.2004.07.062.
Choong CK, Phan L, Massetti P, Haddad FJ, Martinez C, Roschak E, Cooper JD. Prolongation of patency of airway bypass stents with use of drug-eluting stents. J Thorac Cardiovasc Surg. 2006 Jan;131(1):60-4. doi: 10.1016/j.jtcvs.2005.07.057. Epub 2005 Dec 5.
Terry PB, Traystman RJ, Newball HH, Batra G, Menkes HA. Collateral ventilation in man. N Engl J Med. 1978 Jan 5;298(1):10-5. doi: 10.1056/NEJM197801052980103.
Macklem PT. Collateral ventilation. N Engl J Med. 1978 Jan 5;298(1):49-50. doi: 10.1056/NEJM197801052980112. No abstract available.
Choong CK, Macklem PT, Pierce JA, Lefrak SS, Woods JC, Conradi MS, Yablonskiy DA, Hogg JC, Chino K, Cooper JD. Transpleural ventilation of explanted human lungs. Thorax. 2007 Jul;62(7):623-30. doi: 10.1136/thx.2005.053256. Epub 2007 Apr 5.
Cardoso PF, Snell GI, Hopkins P, Sybrecht GW, Stamatis G, Ng AW, Eng P. Clinical application of airway bypass with paclitaxel-eluting stents: early results. J Thorac Cardiovasc Surg. 2007 Oct;134(4):974-81. doi: 10.1016/j.jtcvs.2007.05.040. Epub 2007 Aug 20.
Shah PL, Slebos DJ, Cardoso PF, Cetti E, Voelker K, Levine B, Russell ME, Goldin J, Brown M, Cooper JD, Sybrecht GW; EASE trial study group. Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial. Lancet. 2011 Sep 10;378(9795):997-1005. doi: 10.1016/S0140-6736(11)61050-7.
Shah PL, Slebos DJ, Cardoso PF, Cetti EJ, Sybrecht GW, Cooper JD. Design of the exhale airway stents for emphysema (EASE) trial: an endoscopic procedure for reducing hyperinflation. BMC Pulm Med. 2011 Jan 7;11:1. doi: 10.1186/1471-2466-11-1.
Related Links
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Broncus Technologies, Inc., corporate web page.
American Lung Association
Other Identifiers
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Protocol 30
Identifier Type: -
Identifier Source: org_study_id
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