Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

NCT ID: NCT00205907

Last Updated: 2008-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-04-30

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in 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 Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel 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. The current study will evaluate the safety and efficacy of this procedure 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

BLVR treatment

Group Type: EXPERIMENTAL

BLVR Hydrogel

Intervention Type: BIOLOGICAL

10 mL BLVR Hydrogel

Interventions

BLVR Hydrogel

10 mL BLVR Hydrogel

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of advanced heterogeneous emphysema
• Age > 18 years at the time of initial presentation
• Clinically significant dyspnea (MRC Dyspnea >/= 2)
• Failure of standard medical therapy to provide relief of symptoms
• BUN, creatinine, ALT, AST, alkaline phosphatase, WBC, hematocrit, platelet count, PT and PTT within normal limits
• Pulmonary function tests

Exclusion Criteria

• Alpha-1 protease inhibitor deficiency verified by a serum level of < 80 mg% or knowledge of PI*ZZ genotype
• Body mass index < 15 kg/m2 or > 35 kg/m2
• Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
• Tobacco use within 16 weeks of the initial clinic visit
• Allergy to fish or pork products or sensitivity to tetracycline
• FEV1 <20% with DLCO <20% or homogeneous disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aeris Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Aeris Therapeutics Inc

Principal Investigators

Issahar Ben-Dov, MD

Role: PRINCIPAL_INVESTIGATOR

The Chaim Sheba Medical Center

Locations

Chaim Sheba (Tel Hashomer) Medical Center

Ramat Gan, , Israel

Countries

Israel

Related Links

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi

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.

Other Identifiers

C04-003

Identifier Type: -

Identifier Source: org_study_id