Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

NCT02107209 | Completed Phase 2 DMC

• 1 other identifier: MD68
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Emphysema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-procedure Improvement in dyspnea and exercise capacity

  12 weeks

Study Arms (2)

Bronchoscopic Lung volume reduction using Autologous blood.

EXPERIMENTAL

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

Bronchoscopic Lung volume reduction using Fibrin glue

ACTIVE COMPARATOR

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

Procedure: Bronchoscopic Lung volume reduction

Interventions

Bronchoscopic Lung volume reduction PROCEDURE

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

Bronchoscopic Lung volume reduction using Autologous blood.; Bronchoscopic Lung volume reduction using Fibrin glue

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Airflow limitation with FEV1 \< 20%.
• DLCO \< 20%.
• Current smoker.
• Patients not candidate for FOB.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Chest Medicine Department, Faculty Of Medicine, Mansoura University

Al Mansurah, Al-dakahliya, 35516, Egypt

Location

MeSH Terms

Conditions

Pulmonary Emphysema

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Ahmad Saad El-Morsi, Prof

  Chest Medicine Department, Faculty of Medicine, Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

EG (1)