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

Sponsor

Aeris Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00517998

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Emphysema Chronic Obstructive Pulmonary Disease	Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group1 Treatment will be administered in two sessions.	Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel 10 mL Hydrogel
Experimental: Group2 Treatment will be administered in a single session.	Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel 10 mL Hydrogel

Arm

Intervention/Treatment

Experimental: Group1

Treatment will be administered in two sessions.

Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel

10 mL Hydrogel

Experimental: Group2

Treatment will be administered in a single session.

Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel

10 mL Hydrogel

Outcome Measures

Primary Outcome Measures

SAEs - Safety of treatment and the procedure [1 year]

Secondary Outcome Measures

Reduction in gas trapping [12 weeks]
Improvement in exercise capacity [12 weeks]
Improvement in lung function (vital capacity) [12 weeks]
Improvement in lung function (expiratory flow) [12 weeks]
Improvement on dyspnea symptoms [12 weeks]
Improvement in quality of life [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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