EASE Trial: Exhale Airway Stents for Emphysema

Emphysema Clinical Trial

— EASE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00391612
• Other study ID #: Protocol 30
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 20, 2006
• Last updated: January 10, 2011
• Start date: May 2006
• Est. completion date: December 2013

Study information

• Verified date: January 2011
• Source: Broncus Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesAustria: EthikkommissionAustria: Federal Ministry for Health and WomenUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeNetherlands: Dutch Health Care InspectorateNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 2013
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

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
• 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

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Austria	Otto Wagner Hospital	Vienna
Brazil	Santa Casa Hospital	Porto Alegre	Rio Grande do Sul
Canada	London Health Sciences Centre	London	Ontario
Canada	Hopital Laval	Quebec
Germany	Universitatsklinik des Saarlandes	Homburg	Saar
Ireland	Mater Misericordiae University Hospital	Dublin
Netherlands	University Medical Center, Groningen	Groningen
Spain	Fundación Jiménez Díaz	Madrid
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	The Royal Brompton Hospital	London
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory Healthcare	Atlanta	Georgia
United States	Pulmonary and Critical Care Associates of Baltimore	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	New York Methodist Hospital	Brooklyn	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Henry Ford Hospital & Medical Center	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	UCSF-Fresno	Fresno	California
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	International Heart Institute of Montana Foundation	Missoula	Montana
United States	Columbia University Medical Center	New York	New York
United States	New York University - Bellevue Hospital	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Peoria Pulmonary Associates, LTD	Peoria	Illinois
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Pulmonary Associates, PA	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, Davis Medical Center	Sacramento	California
United States	Sarasota Memorial Health Care System	Sarasota	Florida
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Topeka Pulmonary/Veritas Clinical Specialties, LTD	Topeka	Kansas
United States	Chicago Chest Center at Central DuPage Hospital	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Broncus Technologies

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  Canada,  Germany,  Ireland,  Netherlands,  Spain,  United Kingdom, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Macklem PT. Collateral ventilation. N Engl J Med. 1978 Jan 5;298(1):49-50. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Vital Capacity (FVC)		6 months	No
Primary	modified Medical Research Council (mMRC) score (breathlessness)		6 months	No
Secondary	Residual Volume/Total Lung Capacity (RV/TLC)		6 months	No
Secondary	Forced Vital Capacity (FVC)		6 months	No
Secondary	modified Medical Research Council Dyspnea Scale (mMRC)		6 months	No
Secondary	Forced Expiratory Volume in 1 second (FEV1)		6 months	No
Secondary	St. George's Respiratory Questionnaire (SGRQ)		6 months	No
Secondary	6-minute walk (6MW)		6 months	No
Secondary	Cycle Ergometry		6 months	No
Secondary	Note: Residual Volume/Total Lung Capacity (RV/TLC) will be analyzed for superiority. All other secondary endpoints will be analyzed for informational purposes.		6 months	No
Secondary	Residual Volume (RV)		6 months	No

External Links

•   American Lung Association
•   Broncus Technologies, Inc., corporate web page.