Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joel D. Cooper, MD, FACS, FRCS
Address 0 0
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00391612