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

This study has been completed.
Sponsor:
Information provided by:
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT00085852
First received: June 15, 2004
Last updated: February 27, 2008
Last verified: February 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Heterogeneous Emphysema

Resource links provided by NLM:


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
Experimental: Single
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Aeris Therapeutics:
emphysema
chronic obstructive pulmonary disease
lung volume reduction
bronchoscopic
bronchoscopy
bronchoscope

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014