EASE Trial: Exhale Airway Stents for Emphysema - Full Text View

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 III

MedlinePlus related topics:

Breathing Problems Emphysema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Sham Comparator 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
1: Experimental 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:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391612

Contacts


Contact: Terese Bogucki	650-428-1600 ext 301	tbogucki@broncus.com

Show 39 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

Broncus Technologies, Inc., corporate web page. This link exits the ClinicalTrials.gov site

American Lung Association This link exits the ClinicalTrials.gov site

Patient website to learn about the EASE Trial This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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. 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.

Macklem PT. Collateral ventilation. N Engl J Med. 1978 Jan 5;298(1):49-50. 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. 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. Epub 2007 Aug 20.

Responsible Party:	Broncus Technologies, Inc ( Nancy Isaac, Senior Vice President, Clinical and Regulatory Affairs and Quality Assurance )
Study ID Numbers:	Protocol 30
First Received:	October 20, 2006
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00391612
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

Study placed in the following topic categories:

Pulmonary Emphysema

Emphysema

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Broncus Technologies
Information provided by:	Broncus Technologies
ClinicalTrials.gov Identifier:	NCT00391612