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

Phase 2

Completed

• Conditions: Pulmonary Emphysema
• Interventions: Biological: BLVR Treatment

• Registration Number: NCT00435253
• Lead Sponsor: Aeris Therapeutics

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-07
• Study First Submitted QC: 2007-02-12
• Study First Posted: 2007-02-14
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-21
• Last Update Posted: 2011-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BLVR Treatment	BLVR Treatment	BLVR Treatment

Primary Outcome Measures

Name	Time	Method
Reduction in gas trapping	12 weeks post treatment
SAEs - Safety of treatment and the procedure	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Medical University of South Carolina Hospital; 🇺🇸 Charleston, South Carolina, United States

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States

University of Alabama Birmingham Lung Health Center; 🇺🇸 Birmingham, Alabama, United States

Temple University Lung Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Caritas St Elizabeth's Med Cen; 🇺🇸 Boston, Massachusetts, United States