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

Pulmonary Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00205907
• Other study ID #: C04-003
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: February 27, 2008
• Start date: January 2005
• Est. completion date: April 2007

Study information

• Verified date: February 2008
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

Biological:
• BLVR Hydrogel
10 mL BLVR Hydrogel

Locations

Country	Name	City	State
Israel	Chaim Sheba (Tel Hashomer) Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product-related life-threatening adverse events, permanently disabling complications and deaths		1 year post treatment	Yes
Primary	FEV1		12 weeks post treatment	No
Primary	MRC Dyspnea Score		12 weeks post treatment	No
Primary	Six-Minute Walk Test		12 weeks post treatment	No
Primary	Health-Related Quality of Life		12 weeks post treatment	No
Secondary	Lung function tests		12 weeks post treatment	No
Secondary	Lung volume measures		12 weeks post treatment	No

External 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.