Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

Phase 2

Completed

• Conditions: Pulmonary Emphysema
• Interventions: Procedure: Bronchoscopic Lung volume reduction

• Registration Number: NCT02107209
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Primary Completion: 2015-04
• Study Completion: 2015-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bronchoscopic Lung volume reduction using Fibrin glue	Bronchoscopic Lung volume reduction	injection of 30 ml locally prepared fibrin glue per segment via triple lumen balloon catheter passing through fiberoptic bronchoscopy
Bronchoscopic Lung volume reduction using Autologous blood.	Bronchoscopic Lung volume reduction	Injection of 30 ml autologous blood plus 3ml calcium chloride plus 3 ml tranexamic acid per segment via fiber-optic bronchoscope

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chest Medicine Department, Faculty Of Medicine, Mansoura University; 🇪🇬 Mansoura, Al-dakahliya, Egypt