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

Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01682018
• Other study ID #: RMC126908
• Status: Not yet recruiting
• Phase: N/A
• First received: September 5, 2012
• Last updated: September 7, 2012
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2012
• Source: Rabin Medical Center
• Contact: Mordechai Kramer Kramer, MD
• Phone: 97239377140
• Email: Kremerm[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Emphysema
• Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema

Intervention

Device:
• lung volume reduction using the Zephyr device
lung volume reduction using the Zephyr device

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	•Mean % change in lung function (FEV1)		90 days	No
Secondary	Mean change in six minutes walk distance		90 days	No