Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

NCT ID: NCT00517998

Last Updated: 2010-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-03-31

Brief Summary

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

Detailed Description

Background:

Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.

Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung. This provides room within the chest to allow the remaining healthier portions of the lung to function better.

Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Conditions

Pulmonary Emphysema; Chronic Obstructive Pulmonary Disease

Study Design

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

Study Groups

Group1

Treatment will be administered in two sessions.

Group Type: EXPERIMENTAL

Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel

Intervention Type: DRUG

10 mL Hydrogel

Group2

Treatment will be administered in a single session.

Group Type: EXPERIMENTAL

Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel

Intervention Type: DRUG

10 mL Hydrogel

Interventions

Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel

10 mL Hydrogel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of advanced emphysema
• age >/= 40 years
• clinically significant dyspnea
• failure of standard medical therapy to relieve symptoms (inhaled beta agonist & inhaled anticholinergic)
• pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted & experiencing < 30% or 300 mL improvement using bronchodilator; total lung capacity > 110% predicted; residual volume > 150% predicted)
• 6 Minute Walk Distance >/= 150 m

Exclusion Criteria

• alpha-1 protease inhibitor deficiency
• tobacco use within 4 months of initial visit
• body mass index < 15 kg/m2 or> 35 kg/m2
• clinically significant asthma, chronic bronchitis or bronchiectasis
• allergy or sensitivity to procedural components
• pregnant, lactating or unwilling to use birth control if required
• prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endotracheal valve placement, airway stent placement or pleurodesis
• comorbid condition that could adversely influence outcomes
• significant comorbidity

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

Sponsors

Aeris Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Aeris Therapeutics Inc

Principal Investigators

Yael Refaely, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center

Petach Tivka, , Israel

Countries

Israel

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)

Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754.

Reference Type: BACKGROUND

PMID: 17426216 (View on PubMed)

Other Identifiers

01-C06-002

Identifier Type: -

Identifier Source: org_study_id