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

NCT ID: NCT00347659

Last Updated: 2008-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-09-30

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.

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.

Conditions

Pulmonary Emphysema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Treatment

Experimental Treatment

Group Type: EXPERIMENTAL

BLVR System

Intervention Type: DRUG

Treatment is administered in a single treatment session.

Interventions

BLVR System

Treatment is administered in a single treatment session.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aeris Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Aeris Therapeutics

Locations

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Temple University Lung Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

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. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.

Reference Type: BACKGROUND

PMID: 12406835 (View on PubMed)

Other Identifiers

01-C06-001

Identifier Type: -

Identifier Source: org_study_id