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

Phase 1/Phase 2 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema

The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Emphysema
• Intervention / Treatment: Biological: BLVR Hydrogel

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 52621
    • Chaim Sheba (Tel Hashomer) Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria include:

• 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

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; BLVR treatment	Biological: BLVR Hydrogel; 10 mL BLVR Hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FEV1	12 weeks post treatment
MRC Dyspnea Score	12 weeks post treatment
Product-related life-threatening adverse events, permanently disabling complications and deaths	1 year post treatment
Six-Minute Walk Test	12 weeks post treatment
Health-Related Quality of Life	12 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Lung function tests	12 weeks post treatment
Lung volume measures	12 weeks post treatment

Collaborators and Investigators

• Sponsor: Aeris Therapeutics
• Investigators: Principal Investigator: Issahar Ben-Dov, MD, The Chaim Sheba Medical Center

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

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; emphysema; chronic obstructive pulmonary disease; pulmonary emphysema; COLD; BLVR
• 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: C04-003