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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00391612




Registration number
NCT00391612
Ethics application status
Date submitted
20/10/2006
Date registered
24/10/2006
Date last updated
12/01/2011

Titles & IDs
Public title
EASE Trial: Exhale Airway Stents for Emphysema
Scientific 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
Secondary ID [1] 0 0
Protocol 30
Universal Trial Number (UTN)
Trial acronym
EASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Exhale® Drug-Eluting Stent
Treatment: Devices - Sham control

Sham Comparator: 2 - subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy but no stents are placed

Experimental: 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


Treatment: Devices: 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

Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Forced Vital Capacity (FVC)
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
modified Medical Research Council (mMRC) score (breathlessness)
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Residual Volume/Total Lung Capacity (RV/TLC)
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Forced Vital Capacity (FVC)
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
modified Medical Research Council Dyspnea Scale (mMRC)
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Forced Expiratory Volume in 1 second (FEV1)
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
St. George's Respiratory Questionnaire (SGRQ)
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
6-minute walk (6MW)
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Cycle Ergometry
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Note: Residual Volume/Total Lung Capacity (RV/TLC) will be analyzed for superiority. All other secondary endpoints will be analyzed for informational purposes.
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
Residual Volume (RV)
Timepoint [9] 0 0
6 months

Eligibility
Key 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.
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2013
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Austria
State/province [19] 0 0
Vienna
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio Grande do Sul
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Germany
State/province [23] 0 0
Saar
Country [24] 0 0
Ireland
State/province [24] 0 0
Dublin
Country [25] 0 0
Netherlands
State/province [25] 0 0
Groningen
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Cambridge
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Broncus Technologies
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00391612
Trial related presentations / 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. 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.
Public notes

Contacts
Principal investigator
Name 0 0
Joel D. Cooper, MD, FACS, FRCS
Address 0 0
Universitätskliniken des Saarlandes
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00391612