Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

Evaluation of Bronchoscopic Biological Lung Volume Reduction Therapy in Pulmonary Emphysema Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02107209

Acronym

BLVR

Enrollment

Registered

2014-04-08

Start date

2013-04-30

Completion date

2015-08-31

Last updated

2015-11-11

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

Conditions

Pulmonary Emphysema

Brief summary

The clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction. These include one-way valves, or bronchial occlusive devices to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to improve expiratory flow, wire coils implants that compress the airway and thermal vapor ablation that causes an acute injury with subsequent fibrosis and reductions in volume.

Detailed description

Biologic lung volume reduction (BioLVR): it is a novel endobronchial approach, which uses a Biological agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. The mechanism of action involves resorption atelectasis from airway occlusion, subsequent airspace inflammation, and then remodeling. This remodeling will lead to scarring that induces contraction of lung parenchyma and functional volume reduction can be expected within 6-8 weeks. Biological lung volume reduction occurs independent of the presence or absence of collateral ventilation.

Interventions

PROCEDUREBronchoscopic Lung volume reduction

Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Emphysema determined by HRCT of the chest with: * .Persistent symptoms (i.e. a baseline Modified Medical Research Council dyspnea (MRC) score of \>2 despite medical therapy). * FEV1 /FVC \< 70% and FEV1 20%-50 % (Sever and very sever airflow limitation according to GOLD 2013). * Hyperinflation (total lung capacity (TLC) \> 110% pred and residual volume/total lung capacity (RV/TLC) \> 120% pred. 2. Patients not candidate for or had refused lung volume reduction surgery. 3. Age \> 40 yrs.

Exclusion criteria

1. Airflow limitation with FEV1 \< 20%. 2. DLCO \< 20%. 3. Current smoker. 4. Patients not candidate for FOB.

Design outcomes

Primary

Measure	Time frame	Description
Post-procedure lung volume reduction	12 week	Change from the baseline high-resolution computed tomography (HRCT) volumetry Change from the baseline Residual Volume/Total Lung Capacity from baseline.

Secondary

Measure	Time frame	Description
Post-procedure Improvement in dyspnea and exercise capacity	12 weeks	Changes from the baseline post-bronchodilator forced expiratory volume at one second (FEV1) and forced vital capacity (FVC), diffusing capacity of lung for carbon monoxide (DLCO), six-minute walk distance (6MWD),modified medical research council (MMRC) dyspnea score.

Countries

Egypt

Outcome results

None listed

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