US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.

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 Biologic Lung Volume Reduction (BLVR) 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. This study will evaluate the safety of the BLVR System in patients with advanced emphysema.

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

Conditions
-----------------
Pulmonary Emphysema

Intervention / Treatment
-----------------
* Drug: BLVR System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of advanced heterogeneous emphysema Age >/= 40 Clinically significant dyspnea Failure of standard medical therapy to relieve symptoms Pulmonary function tests with protocol-specified ranges Exclusion Criteria: Alpha-1 protease inhibitor deficiency Tobacco use within 16 weeks of initial clinic visit Body mass index < 15 kg/m2 or > 35 kg/m@ Clinically significant asthma, chronic bronchitis or bronchiectasis Allergy or sensitivity to tetracycline Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Treatment<br>Experimental Treatment | Drug: BLVR System<br>* Treatment is administered in a single treatment session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAEs - Safety of the procedure from initiation of treatment through hospital discharge. |  | 1 week post treatment | 
| SAEs - Safety of the treatment through Week 12. |  | 12 weeks post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAEs - Safety of the treatment through Week 48. |  | 48 weeks post treatment | 
| Evaluation of radiologic changes. |  | 12 weeks post treatment | 
| Improvement in exercise capacity. |  | 12 weeks post treatment | 
| Improvement in quality of life. |  | 12 weeks post treatment | 
| Decrease in trapped gas. |  | 12 weeks post treatment | 
| Improvement in lung function. |  | 12 weeks post trreatment | 
| Improvement in symptoms. |  | 12 weeks post treatment | 

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