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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effective dose of the Aeris BLVR System in 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 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. This study will evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

Official Title
-----------------
Dose Escalation Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema

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

Intervention / Treatment
-----------------
* Biological: BLVR Hydrogel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria include: Clinical diagnosis of advanced emphysema Age > 18 years at the time of initial presentation Clinically significant dyspnea (MRC Dyspnea >/= 2) Laboratory tests within protocol-specified ranges Pulmonary function tests Exclusion Criteria include: Alpha-1 protease inhibitor deficiency verified by a serum level of <80mg% or knowledge of PI*ZZ genotype Tobacco use within 16 weeks of the initial clinic visit Body mass index < 15 kg/m2 or > 35 kg/m2 Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis Allergy to fish or pork products or sensitivity to tetracycline FEV1 <20% predicted with DLCO <20% predicted or homogeneous disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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<br>BLVR Treatment | Biological: BLVR Hydrogel<br>* 10 mL BLVR Hydrogel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Include: Product-related life-threatening adverse events, permanently disabling complications and deaths |  | 1 year post treatment | 
| FEV1 |  | 12 weeks post treatment | 
| MRC Dyspnea Score |  | 12 weeks post treatment | 
| Six-Minute Walk Test |  | 12 week post treatment | 
| Health-Related Quality of Life |  | 12 week post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Include: Lung function tests |  | 12 week post treatment | 
| Lung volume measurements |  | 12 week post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emphysema, pulmonary emphysema, COPD, COLD, chronic obstructive pulmonary disease