The Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung

Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung

The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests.

Study Overview

• Status: Unknown
• Conditions: Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema
• Intervention / Treatment: Device: lung volume reduction using the Zephyr device

Detailed Description

Emphysema is a progressive pulmonary disease characterized by abnormal and permanent enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit from surgical lung volume reduction and/or lung transplantation. The rationale for lung volume reduction surgery is that reducing lung size would restore elastic recoil of the lung and improve chest wall and diaphragm mechanics. It has previously been shown that particularly patients with heterogeneous emphysema seem to benefit most from surgical lung volume reduction.

Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR.

The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel, 92100
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Single lung transplantation due to emphysema at least six months following transplantation that developed native lung overinflation

• Age from 40 to 75 years
• BMI < 32 kg/m2
• FEV1 < 40% of predicted value, FEV1/FVC < 70%
• TLC > 120% predicted, RV > 150% predicted.
• Stable with < 20 mg prednisone (or equivalent) qd
• PaCO2 < 50mm Hg
• PaO2 > 45 mm Hg on room air
• 6-min walk of > 50m (without rehabilitation) or > 100m (with rehabilitation)
• Nonsmoking for 4 months prior to initial interview and throughout screening
• The patient agrees to all protocol required follow-up intervals.
• The patient has no child bearing potential
• The patient is willing and able to complete protocol required baseline assessments and procedures Exclusion criteria
• Prior endobronchial treatment for emphysema
• Pleural or interstitial disease that precludes surgery.
• Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy.
• Clinically significant bronchiectasis
• Pulmonary nodule requiring surgery
• History of recurrent respiratory infections (> 3 hospitalization in the last year)
• Clinically significant (> 4 Tablespoons per day) sputum production
• Fever, elevated white cell count, or other evidence of active infection
• Dysrhythmia that might pose a risk during exercise or training
• Congestive heart failure within 6 mo and LVEF < 45%
• Evidence or history of Cor Pulmonale
• Resting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
• History of exercise-related syncope
• MI within 6 mo and LVEF < 45%
• Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period
• Any disease or condition that interferes with completion of initial or follow-up assessments
• Patient is currently enrolled in another clinical trial
• Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer
• Alpha-1-Antitrypsin Deficiency

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Patients that underwent dingle lung transplantation due to emphysema and developed native lung overinflation as demonstrated by chest CT and decline in pulmonary lung function tests (FEV1 ) shall undergo valves placement to the native lung	Device: lung volume reduction using the Zephyr device; lung volume reduction using the Zephyr device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
•Mean % change in lung function (FEV1)	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change in six minutes walk distance	90 days

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (Estimate): September 10, 2012

Study Record Updates

• Last Update Posted (Estimate): September 10, 2012
• Last Update Submitted That Met QC Criteria: September 7, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: emphysema; lung transplantation
• 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: RMC126908