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

This study is not yet open for participant recruitment.
Verified July 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01682018
First received: September 5, 2012
Last updated: September 7, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema
Device: lung volume reduction using the Zephyr device

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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • •Mean % change in lung function (FEV1) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in six minutes walk distance [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682018

Contacts
Contact: Mordechai Kramer Kramer, MD 97239377140 Kremerm@clalit.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petah Tikva, Israel, 92100
Contact: Mordechai R Kramer, MD    97239377140    kremerm@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01682018     History of Changes
Other Study ID Numbers: RMC126908
Study First Received: September 5, 2012
Last Updated: September 7, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
emphysema
lung transplantation

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014