Back to resultsUS 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation
Primary Purpose
Pulmonary Emphysema
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BLVR
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Emphysema focused on measuring emphysema, chronic obstructive pulmonary disease, lung volume reduction, bronchoscopic, bronchoscopy, bronchoscope
Eligibility Criteria
Inclusion Criteria: Advanced emphysema Limited exercise capacity and persistent symptoms despite medical therapy Age between 18 and 75 No significant heart, kidney or liver disease Willingness and ability to tolerate bronchoscopy No prior Lung Volume Reduction Surgery or Lung Transplantation Screening test results indicating that the procedure is appropriate
Sites / Locations
- Brigham and Women's Hospital
- Caritas St Elizabeth's Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single
Arm Description
Treatment with BLVR
Outcomes
Primary Outcome Measures
SAEs - Safety
Secondary Outcome Measures
PFTs
Dyspnea
Exercise capacity
QOL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00085852
Brief Title
US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation
Official Title
Phase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Heterogeneous Emphysema
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aeris Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.
Detailed Description
Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. Recently, lung volume reduction surgery has become an accepted therapy for emphysema. Lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. This procedure, although effective, is complicated and risky.
Aeris Therapeutics has developed the Aeris Bronchoscopic Lung Volume Reduction System for treatment of patients with advanced emphysema. The Aeris BLVR System is designed to reduce lung volume without surgery. Patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. The purpose of the current study is to find out whether the Aeris BLVR System is safe in patients with advanced emphysema. The risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Emphysema
Keywords
emphysema, chronic obstructive pulmonary disease, lung volume reduction, bronchoscopic, bronchoscopy, bronchoscope
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Experimental
Arm Description
Treatment with BLVR
Intervention Type
Biological
Intervention Name(s)
BLVR
Intervention Description
10 mL Hydrogel
Primary Outcome Measure Information:
Title
SAEs - Safety
Time Frame
1 year post treatment
Secondary Outcome Measure Information:
Title
PFTs
Time Frame
12 weeks post treatment
Title
Dyspnea
Time Frame
12 weeks post treatment
Title
Exercise capacity
Time Frame
12 weeks post treatment
Title
QOL
Time Frame
12 weeks post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced emphysema
Limited exercise capacity and persistent symptoms despite medical therapy
Age between 18 and 75
No significant heart, kidney or liver disease
Willingness and ability to tolerate bronchoscopy
No prior Lung Volume Reduction Surgery or Lung Transplantation
Screening test results indicating that the procedure is appropriate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J. Reilly, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Caritas St Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12406835
Citation
Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.
Results Reference
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US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation
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