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

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Emphysema
• Intervention / Treatment: Drug: BLVR System

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Caritas St. Elizabeth's Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Lung Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SAEs - Safety of the procedure from initiation of treatment through hospital discharge.	1 week post treatment
SAEs - Safety of the treatment through Week 12.	12 weeks post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
SAEs - Safety of the treatment through Week 48.	48 weeks post treatment
Evaluation of radiologic changes.	12 weeks post treatment
Improvement in exercise capacity.	12 weeks post treatment
Improvement in quality of life.	12 weeks post treatment
Decrease in trapped gas.	12 weeks post treatment
Improvement in lung function.	12 weeks post trreatment
Improvement in symptoms.	12 weeks post treatment

Collaborators and Investigators

• Sponsor: Aeris Therapeutics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: June 30, 2006
• First Submitted That Met QC Criteria: June 30, 2006
• First Posted (Estimate): July 4, 2006

Study Record Updates

• Last Update Posted (Estimate): March 6, 2008
• Last Update Submitted That Met QC Criteria: February 27, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: COPD; Bronchoscopy; Emphysema; Lung disease; COLD; BLVR; Lung volume reduction; NETT
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 01-C06-001