EASE Trial: Exhale Airway Stents for Emphysema

NCT00391612 | Unknown Phase 3

• 1 other identifier: Protocol 30
• Study Type: interventional
• Target: 450
• Locations: 9 countries
• Sites: 36

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.

Conditions

Emphysema

Keywords

COPD (Chronic Obstructive Pulmonary Disease); Emphysema; Hyperinflation; Minimally Invasive

Outcome Measures

Primary Outcomes (2)

• Forced Vital Capacity (FVC)

  6 months

• modified Medical Research Council (mMRC) score (breathlessness)

  6 months

Secondary Outcomes (9)

• Residual Volume/Total Lung Capacity (RV/TLC)

  6 months

• Forced Vital Capacity (FVC)

  6 months

• modified Medical Research Council Dyspnea Scale (mMRC)

  6 months

• Forced Expiratory Volume in 1 second (FEV1)

  6 months

• St. George's Respiratory Questionnaire (SGRQ)

  6 months

Study Arms (2)

2

SHAM COMPARATOR

subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy but no stents are placed

Device: Sham control

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

Interventions

Exhale® Drug-Eluting Stent DEVICE

Bronchoscopic procedure in which up to six Exhale Drug-Eluting Stents are placed in the lungs; total procedure time is 1 to 2 hours

1

Sham control DEVICE

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

2

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Broncus Technologies: lead

Study Sites (37)

Pulmonary Associates, PA

Phoenix, Arizona, 85006, United States

Location

UCSF-Fresno

Fresno, California, 93701, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Emory Healthcare

Atlanta, Georgia, 30322, United States

Location

Peoria Pulmonary Associates, LTD

Peoria, Illinois, 61603, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62781, United States

Location

Chicago Chest Center at Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Topeka Pulmonary/Veritas Clinical Specialties, LTD

Topeka, Kansas, 66606, United States

Location

Pulmonary and Critical Care Associates of Baltimore

Baltimore, Maryland, 21237, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital & Medical Center

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

International Heart Institute of Montana Foundation

Missoula, Montana, 59802, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

New York University - Bellevue Hospital

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

Otto Wagner Hospital

Vienna, Austria

Location

Santa Casa Hospital

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Hopital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Universitatsklinik des Saarlandes

Homburg, Saarland, 66421, Germany

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

University Medical Center, Groningen

Groningen, 9700 RB, Netherlands

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Papworth Hospital

Cambridge, CB23 3RE, United Kingdom

Location

The Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 12607646 BACKGROUND

• 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.

  PMID: 12830047 BACKGROUND

• 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.

  PMID: 15746748 BACKGROUND

• 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.

  PMID: 16399295 BACKGROUND

• 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.

  PMID: 618444 BACKGROUND

• Macklem PT. Collateral ventilation. N Engl J Med. 1978 Jan 5;298(1):49-50. doi: 10.1056/NEJM197801052980112. No abstract available.

  PMID: 618452 BACKGROUND

• 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.

  PMID: 17412776 BACKGROUND

• 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.

  PMID: 17903516 BACKGROUND

• 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.

  PMID: 21907863 DERIVED

• 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.

  PMID: 21214899 DERIVED

Related Links

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

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Joel D. Cooper, MD, FACS, FRCS

  PRINCIPAL INVESTIGATOR

• Gerhard W. Sybrecht, Prof. Dr. med.

  Universitätskliniken des Saarlandes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 24, 2006
• Study Start: May 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2013
• Last Updated: January 12, 2011

Record last verified: 2011-01

Locations

US (26); BR (1); IE (1); AU (1); NL (1); ES (1); GB (2); CA (2); DE (1)