Clinical trial NCT00391612: EASE Trial: Exhale Airway Stents for Emphysema
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Emphysema
Keywords: COPD (Chronic Obstructive Pulmonary Disease)
Emphysema
Hyperinflation
Minimally Invasive
Lead sponsor: Broncus Technologies
Sponsor class: INDUSTRY
First posted: 2006-10-24
Enrollment: 450
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: 6 months
measure: modified Medical Research Council (mMRC) score (breathlessness)
timeFrame: 6 months
Secondary outcomes:
measure: Residual Volume/Total Lung Capacity (RV/TLC)
timeFrame: 6 months
measure: Forced Vital Capacity (FVC)
timeFrame: 6 months
measure: modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: 6 months
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 6 months
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 6 months
measure: 6-minute walk (6MW)
timeFrame: 6 months
measure: Cycle Ergometry
timeFrame: 6 months
measure: Note: Residual Volume/Total Lung Capacity (RV/TLC) will be analyzed for superiority. All other secondary endpoints will be analyzed for informational purposes.
timeFrame: 6 months
measure: Residual Volume (RV)
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates, PA
state: Arizona
city: Fresno
country: United States
facility: UCSF-Fresno
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Peoria
country: United States
facility: Peoria Pulmonary Associates, LTD
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Winfield
country: United States
facility: Chicago Chest Center at Central DuPage Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Topeka
country: United States
facility: Topeka Pulmonary/Veritas Clinical Specialties, LTD
state: Kansas
city: Baltimore
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital & Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Missoula
country: United States
facility: International Heart Institute of Montana Foundation
state: Montana
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: New York
country: United States
facility: New York University - Bellevue Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Vienna
country: Austria
facility: Otto Wagner Hospital
city: Porto Alegre
country: Brazil
facility: Santa Casa Hospital
state: Rio Grande do Sul
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Quebec
country: Canada
facility: Hopital Laval
city: Homburg
country: Germany
facility: Universitatsklinik des Saarlandes
state: Saar
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Groningen
country: Netherlands
facility: University Medical Center, Groningen
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: London
country: United Kingdom
facility: The Royal Brompton Hospital
Study officials:
name: Joel D. Cooper, MD, FACS, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätskliniken des Saarlandes
name: Gerhard W. Sybrecht, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0003-4975(02)04553-8.
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. doi: 10.1016/s0022-5223(02)73243-1.
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. doi: 10.1016/j.jtcvs.2004.07.062.
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. doi: 10.1016/j.jtcvs.2005.07.057. Epub 2005 Dec 5.
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. doi: 10.1056/NEJM197801052980103.
citation: Macklem PT. Collateral ventilation. N Engl J Med. 1978 Jan 5;298(1):49-50. doi: 10.1056/NEJM197801052980112. No abstract available.
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. doi: 10.1136/thx.2005.053256. Epub 2007 Apr 5.
citation: 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.
citation: 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.
citation: 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.