US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation - Full Text View

Purpose

The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.

Condition	Intervention	Phase
Pulmonary Emphysema	Biological: BLVR	Phase I

MedlinePlus related topics:

Emphysema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	Phase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Heterogeneous Emphysema

Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:

SAEs - Safety [ Time Frame: 1 year post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PFTs [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
Dyspnea [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
Exercise capacity [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
QOL [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]

Enrollment:	6
Study Start Date:	April 2005
Study Completion Date:	June 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single: Experimental Treatment with BLVR	Biological: BLVR 10 mL Hydrogel

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085852

Locations


United States, Massachusetts
	Brigham and Women's Hospital
	Boston, Massachusetts, United States, 02115
	Caritas St Elizabeth's Medical Center
	Boston, Massachusetts, United States, 02135

Sponsors and Collaborators

Aeris Therapeutics

Investigators


Principal Investigator:	John J. Reilly, MD	Brigham and Women's Hospital

More Information

Publications:

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. Epub 2002 Oct 11.

Responsible Party:	Aeris Therapeutics Inc ( Edward P Ingenito, MD, PhD, Medical Director & CSO )
Study ID Numbers:	C04-001, IRB Protocol # 2003-P-002171
First Received:	June 15, 2004
Last Updated:	February 27, 2008
ClinicalTrials.gov Identifier:	NCT00085852
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aeris Therapeutics:

emphysema

chronic obstructive pulmonary disease

lung volume reduction

bronchoscopic

bronchoscopy

bronchoscope

Study placed in the following topic categories:

Pulmonary Emphysema

Emphysema

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Aeris Therapeutics
Information provided by:	Aeris Therapeutics
ClinicalTrials.gov Identifier:	NCT00085852