Clinical Trial: Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Mansoura University

Current Primary Outcome: Post-procedure lung volume reduction [ Time Frame: 12 week ]

Change from the baseline high-resolution computed tomography (HRCT) volumetry Change from the baseline Residual Volume/Total Lung Capacity from baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome: Post-procedure Improvement in dyspnea and exercise capacity [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Mansoura University

Dates:
Date Received: April 2, 2014
Date Started: April 2013
Date Completion:
Last Updated: November 10, 2015
Last Verified: November 2015