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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00435253

Enrollment

Registered

2007-02-14

Start date

2007-02-28

Completion date

2009-06-30

Last updated

2011-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Emphysema

Keywords

emphysema, COPD, lung volume reduction, NETT, BLVR, biologic lung volume reduction, bronchoscopic lung volume reduction

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.

Interventions

BIOLOGICALBLVR Treatment

BLVR Treatment, 10 mL Hydrogel

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Improvement in inspiratory flow	12 weeks post treatment
Improvement in dyspnea symptoms (breathlessness)	12 weeks post treatment
Improvement in vital capacity	12 weeks post treatment
Improvement in respiratory quality of life	12 weeks post treatment
Improvement in exercise capacity	12 weeks post treatment
Improvement in expiratory flow	12 weeks post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026