US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

Study Overview
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Brief Summary
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Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Detailed Description
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Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.

Official Title
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Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema

Conditions
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Pulmonary Emphysema

Intervention / Treatment
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* Biological: BLVR Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of advanced upper lobe predominant emphysema age >/= 40 years clinically significant dyspnea failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic) pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted and experiencing < 30% or 300 mL improvement using bronchodilator; TLC > 110% predicted; RV > 150% predicted) 6 Minute Walk Distance >/= 150 m Exclusion Criteria: alpha-1 protease inhibitor deficiency homogeneous disease 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, endobronchial valve placement, airway stent placement or pleurodesis comorbid condition that could adversely influence outcomes inability to tolerate bronchoscopy under conscious sedation (or anesthesia)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: BLVR Treatment<br>BLVR Treatment | Biological: BLVR Treatment<br>* BLVR Treatment, 10 mL Hydrogel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in gas trapping |  | 12 weeks post treatment | 
| SAEs - Safety of treatment and the procedure |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in vital capacity |  | 12 weeks post treatment | 
| Improvement in expiratory flow |  | 12 weeks post treatment | 
| Improvement in inspiratory flow |  | 12 weeks post treatment | 
| Improvement in dyspnea symptoms (breathlessness) |  | 12 weeks post treatment | 
| Improvement in exercise capacity |  | 12 weeks post treatment | 
| Improvement in respiratory quality of life |  | 12 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emphysema, COPD, lung volume reduction, NETT, BLVR, biologic lung volume reduction, bronchoscopic lung volume reduction