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

Primary Purpose

Pulmonary Emphysema

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bronchoscopic Lung volume reduction
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Emphysema

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chest Medicine Department, Faculty Of Medicine, Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bronchoscopic Lung volume reduction using Autologous blood.

Bronchoscopic Lung volume reduction using Fibrin glue

Arm Description

Injection of 30 ml autologous blood plus 3ml calcium chloride plus 3 ml tranexamic acid per segment via fiber-optic bronchoscope

injection of 30 ml locally prepared fibrin glue per segment via triple lumen balloon catheter passing through fiberoptic bronchoscopy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 2, 2014
Last Updated
November 10, 2015
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02107209
Brief Title
Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema
Acronym
BLVR
Official Title
Evaluation of Bronchoscopic Biological Lung Volume Reduction Therapy in Pulmonary Emphysema Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bronchoscopic Lung volume reduction using Autologous blood.
Arm Type
Experimental
Arm Description
Injection of 30 ml autologous blood plus 3ml calcium chloride plus 3 ml tranexamic acid per segment via fiber-optic bronchoscope
Arm Title
Bronchoscopic Lung volume reduction using Fibrin glue
Arm Type
Active Comparator
Arm Description
injection of 30 ml locally prepared fibrin glue per segment via triple lumen balloon catheter passing through fiberoptic bronchoscopy
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopic Lung volume reduction
Intervention Description
Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment
Primary Outcome Measure Information:
Title
Post-procedure lung volume reduction
Description
Change from the baseline high-resolution computed tomography (HRCT) volumetry Change from the baseline Residual Volume/Total Lung Capacity from baseline.
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Post-procedure Improvement in dyspnea and exercise capacity
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patients not candidate for or had refused lung volume reduction surgery. Age > 40 yrs. Exclusion Criteria: Airflow limitation with FEV1 < 20%. DLCO < 20%. Current smoker. Patients not candidate for FOB.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Saad El-Morsi, Prof
Organizational Affiliation
Chest Medicine Department, Faculty of Medicine, Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Chest Medicine Department, Faculty Of Medicine, Mansoura University
City
Mansoura
State/Province
Al-dakahliya
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

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Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

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