Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

Pulmonary Emphysema Clinical Trial

— BLVR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107209
• Other study ID #: MD68
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2014
• Last updated: November 10, 2015
• Start date: April 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Procedure:
• Bronchoscopic Lung volume reduction
Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment

Locations

Country	Name	City	State
Egypt	Chest Medicine Department, Faculty Of Medicine, Mansoura University	Mansoura	Al-dakahliya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes