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

Pulmonary Emphysema Clinical Trial

Official title:

Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347659
• Other study ID #: 01-C06-001
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2006
• Last updated: February 27, 2008
• Start date: June 2006
• Est. completion date: September 2007

Study information

• Verified date: February 2008
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Drug:
• BLVR System
Treatment is administered in a single treatment session.

Locations

Country	Name	City	State
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Temple University Lung Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAEs - Safety of the procedure from initiation of treatment through hospital discharge.		1 week post treatment	Yes
Primary	SAEs - Safety of the treatment through Week 12.		12 weeks post procedure	Yes
Secondary	SAEs - Safety of the treatment through Week 48.		48 weeks post treatment	Yes
Secondary	Evaluation of radiologic changes.		12 weeks post treatment	No
Secondary	Improvement in exercise capacity.		12 weeks post treatment	No
Secondary	Improvement in quality of life.		12 weeks post treatment	No
Secondary	Decrease in trapped gas.		12 weeks post treatment	No
Secondary	Improvement in lung function.		12 weeks post trreatment	No
Secondary	Improvement in symptoms.		12 weeks post treatment	No