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OpenTrials
Completed

NCT Number: NCT02107209

Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

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.

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Key information

Conditions

Pulmonary Emphysema Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chest Medicine Department, Faculty Of Medicine, Mansoura University

Al Mansurah, Al-dakahliya, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bronchoscopic Lung volume reduction

Procedure

Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: BLVR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2014
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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