EUROPT Clinical Trial to Study the Efficacy of One-Way Valve Implantation (New Treatment Algorithm) in Patients With Heterogeneous Emphysema

NCT ID: NCT00730301

Last Updated: 2008-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31

Brief Summary

The purpose of this study is to assess the efficacy of a new treatment algorithm for bronchoscopic lung volume reduction (BLVR) in patients with emphysema based on the information of emphysema heterogeneity, destruction score, and fissure analysis.

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. Recent trials of BLVR using endobronchial one-way valves demonstrated significant improvements in lung function parameters, exercise capacity and quality of life in patients with end-stage emphysema. The treatment algorithm for valve implantations to achieve BLVR, however, varied considerably in these reports as well as clinical and functional response rates. Subset analysis of these studies revealed that particularly, but not exclusively, patients with radiological signs of lung volume reduction treated unilaterally showed significant clinical improvements, whereas most patients without signs of lung volume reduction did not experience these benefits. The present study investigates the response to BLVR based on a new treatment algorithm including lung function criteria and computed tomography of the thorax.

Conditions

Emphysema; Chronic Obstructive Pulmonary Disease

Keywords

Emphysema; Chronic obstructive pulmonary disease; Lung volume reduction; Lung function

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Bronchoscopic Lung Volume Reduction (BLVR)

Procedure under general anesthesia.

Intervention Type: PROCEDURE

Other Intervention Names

ZephyrTM Endobronchial Valve (EBV) (Emphasys Medical, Inc., Redwood City, CA)

Eligibility Criteria

Inclusion Criteria

• Patient diagnosed by HRCT Core Lab with eligible heterogeneous disease distribution and at least one complete oblique fissure.
• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

NETWORK

Sponsor Role: lead

Responsible Party

Ludwig Boltzmann Institut for COPD

Principal Investigators

Arschang Valipour, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann Institute for COPD

Locations

Otto Wagner Hospital

Vienna, Vienna, Austria

Site Status: RECRUITING

University Antwerp

Antwerp, , Belgium

Site Status: RECRUITING

University Brussels

Brussels, , Belgium

Site Status: RECRUITING

Countries

Austria; Belgium

Central Contacts

Arschang Valipour, MD

Role: CONTACT

Phone: +43-1-91060-41833

Email: arschang.valipour@wienkav.at

Facility Contacts

Arschang Valipour, MD

Role: primary

Paul Germonpre, MD

Role: primary

Marc Meysman, MD

Role: primary

Other Identifiers

EUROPT 07-074-0507

Identifier Type: -

Identifier Source: org_study_id