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

Aeris Therapeutics

Status and phase

Completed

Phase 2

Conditions

Pulmonary Emphysema

Treatments

Biological: BLVR Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00435253

01-C06-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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)