Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema (BLVR)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Emphysema
• Intervention / Treatment: Procedure: Bronchoscopic Lung volume reduction

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Al-dakahliya
    • Mansoura, Al-dakahliya, Egypt, 35516
      • Chest Medicine Department, Faculty Of Medicine, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bronchoscopic Lung volume reduction using Autologous blood.; Injection of 30 ml autologous blood plus 3ml calcium chloride plus 3 ml tranexamic acid per segment via fiber-optic bronchoscope	Procedure: Bronchoscopic Lung volume reduction; Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment
Active Comparator: Bronchoscopic Lung volume reduction using Fibrin glue; injection of 30 ml locally prepared fibrin glue per segment via triple lumen balloon catheter passing through fiberoptic bronchoscopy	Procedure: Bronchoscopic Lung volume reduction; Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-procedure Improvement in dyspnea and exercise capacity	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.	12 weeks

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Ahmad Saad El-Morsi, Prof, Chest Medicine Department, Faculty Of Medicine, Mansoura University

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): November 11, 2015
• Last Update Submitted That Met QC Criteria: November 10, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: MD68