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US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation
This study has been completed.
Study NCT00085852   Information provided by Aeris Therapeutics
First Received: June 15, 2004   Last Updated: February 27, 2008   History of Changes

June 15, 2004
February 27, 2008
April 2005
SAEs - Safety [ Time Frame: 1 year post treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00085852 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation
Phase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Heterogeneous Emphysema

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

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.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Pulmonary Emphysema
Biological: BLVR
Experimental: Treatment with BLVR
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
6
June 2007
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00085852
Edward P Ingenito, MD, PhD, Medical Director & CSO, Aeris Therapeutics Inc
C04-001, IRB Protocol # 2003-P-002171
Aeris Therapeutics
 
Principal Investigator: John J. Reilly, MD Brigham and Women's Hospital
Aeris Therapeutics
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP