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US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347659
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : March 6, 2008
Information provided by:
Aeris Therapeutics

Brief Summary:
The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.

Condition or disease Intervention/treatment Phase
Pulmonary Emphysema Drug: BLVR System Phase 1

Detailed Description:

Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.

Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Biologic Lung Volume Reduction (BLVR) System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety of the BLVR System in patients with advanced emphysema.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
Study Start Date : June 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: Single Treatment
Experimental Treatment
Drug: BLVR System
Treatment is administered in a single treatment session.

Primary Outcome Measures :
  1. SAEs - Safety of the procedure from initiation of treatment through hospital discharge. [ Time Frame: 1 week post treatment ]
  2. SAEs - Safety of the treatment through Week 12. [ Time Frame: 12 weeks post procedure ]

Secondary Outcome Measures :
  1. SAEs - Safety of the treatment through Week 48. [ Time Frame: 48 weeks post treatment ]
  2. Evaluation of radiologic changes. [ Time Frame: 12 weeks post treatment ]
  3. Improvement in exercise capacity. [ Time Frame: 12 weeks post treatment ]
  4. Improvement in quality of life. [ Time Frame: 12 weeks post treatment ]
  5. Decrease in trapped gas. [ Time Frame: 12 weeks post treatment ]
  6. Improvement in lung function. [ Time Frame: 12 weeks post trreatment ]
  7. Improvement in symptoms. [ Time Frame: 12 weeks post treatment ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of advanced heterogeneous emphysema
  • Age >/= 40
  • Clinically significant dyspnea
  • Failure of standard medical therapy to relieve symptoms
  • Pulmonary function tests with protocol-specified ranges

Exclusion Criteria:

  • Alpha-1 protease inhibitor deficiency
  • Tobacco use within 16 weeks of initial clinic visit
  • Body mass index < 15 kg/m2 or > 35 kg/m@
  • Clinically significant asthma, chronic bronchitis or bronchiectasis
  • Allergy or sensitivity to tetracycline
  • Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347659

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United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Pennsylvania
Temple University Lung Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Aeris Therapeutics
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Responsible Party: Edward Ingenito, MD, PhD, Medical Director &CSO, Aeris Therapeutics Identifier: NCT00347659    
Other Study ID Numbers: 01-C06-001
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: March 6, 2008
Last Verified: February 2008
Keywords provided by Aeris Therapeutics:
Lung volume reduction
Lung disease
Additional relevant MeSH terms:
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Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases