Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00207337




Registration number
NCT00207337
Ethics application status
Date submitted
12/09/2005
Date registered
21/09/2005
Date last updated
23/01/2008

Titles & IDs
Public title
Exhale (R) Stent for Emphysema
Scientific title
A Prospective Feasibility Study to Evaluate the Safety and Performance of the Exhale(R) Drug-Eluting Stent System in Patients With Emphysema
Secondary ID [1] 0 0
0304-28
Universal Trial Number (UTN)
Trial acronym
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: Exhale Drug-Eluting Stent
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedural and technical success - operatively
Timepoint [1] 0 0
Primary outcome [2] 0 0
Decrease in residual volume > 300mL from baseline
Timepoint [2] 0 0
Primary outcome [3] 0 0
Safety
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Dyspnea scoring
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Pulmonary function measures
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Exercise tolerance
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Quality of life measures
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
1. High resolution computed tomography (CT) scan evidence of bilateral emphysema

2. Residual volume (RV) = 220% predicted.

3. Total lung capacity (TLC) = 133% of predicted value.

4. Forced expiratory volume (FEV1) < 40% of predicted or FEV1 < 1 liter.

5. Marked dyspnea, scoring = 2 on the modified Medical Research Council scale of 0-4.

6. Patient has undergone pulmonary rehabilitation of 16 - 20 sessions.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. FEV1 > 20%

2. Diffusing capacity for carbon monoxide (DLco) < 15% of predicted.

3. Respiratory infection requiring > 3 hospitalizations in past year

4. Inability to walk > 140 meters in 6 minutes

5. Giant bulla > 1/3 of one lung's volume

6. Previous lung volume reduction surgery (LVRS) or lobectomy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Rode Road, Chermside
Recruitment hospital [2] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Burwood
Recruitment postcode(s) [1] 0 0
4032 - Rode Road, Chermside
Recruitment postcode(s) [2] 0 0
3181 - Prahran
Recruitment postcode(s) [3] 0 0
2134 - Burwood
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Porto Alegre
Country [2] 0 0
Germany
State/province [2] 0 0
Saarland
Country [3] 0 0
Germany
State/province [3] 0 0
Hannover

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

Ethics approval
Ethics application status

Summary
Brief summary
Current treatment for emphysema is limited to measures that include inhaled oxygen,
bronchodilators, anti-inflammatory drugs and pulmonary rehabilitation. Highly invasive
procedures such as lung volume reduction surgery or lung transplantation are also performed.
Treatment using the Exhale Drug-Eluting Stent (DES) is a minimally invasive bronchoscopic
treatment that has the potential to reduce shortness of breath in emphysema patients. This
study tests the safety and effects of Exhale DES in the treatment of patients with emphysema.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00207337
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory I. Snell, MD
Address 0 0
The Alfred
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/NCT00207337