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

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Emphysema, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAEs - Safety of treatment and the procedure |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung volume reduction, Bronchoscopy, Emphysema, COPD, NETT, Lung disease, COLD, BLVR