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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730301
Recruitment Status : Unknown
Verified August 2008 by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology.
Recruitment status was:  Recruiting
First Posted : August 8, 2008
Last Update Posted : August 8, 2008
Information provided by:
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

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.

Condition or disease Intervention/treatment Phase
Emphysema Chronic Obstructive Pulmonary Disease Procedure: Bronchoscopic Lung Volume Reduction (BLVR) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Clinical Trial Designed to Study the Efficacy of One-Way Valve Implantation Based on a New Treatment Algorithm in Patients With Heterogeneous Emphysema
Study Start Date : July 2007
Estimated Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Intervention Details:
  • Procedure: Bronchoscopic Lung Volume Reduction (BLVR)
    Procedure under general anesthesia.
    Other Name: ZephyrTM Endobronchial Valve (EBV) (Emphasys Medical, Inc., Redwood City, CA)

Primary Outcome Measures :
  1. Mean % change in lung function (FEV1) [ Time Frame: 90 days post index bronchoscopic lung volume reduction ]

Secondary Outcome Measures :
  1. Mean % change in target lobe Residual Volume and Total Lung Capacity. Mean absolute change in dyspnea (mMRC-Score), Quality of life using St. George's Respiratory Questionnaire and SF-36. [ Time Frame: 90 days post-index bronchoscopic lung volume reduction ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00730301

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Contact: Arschang Valipour, MD +43-1-91060-41833

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Otto Wagner Hospital Recruiting
Vienna, Austria, 1140
Contact: Arschang Valipour, MD   
University Antwerp Recruiting
Antwerp, Belgium
Contact: Paul Germonpre, MD   
Principal Investigator: Paul Germonpre, MD         
University Brussels Recruiting
Brussels, Belgium
Contact: Marc Meysman, MD   
Principal Investigator: Marc Meysman, MD         
Sponsors and Collaborators
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
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Principal Investigator: Arschang Valipour, MD Ludwig Boltzmann Institute for COPD

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Responsible Party: Arschang Valipour, M.D., Ludwig Boltzmann Institut for COPD Identifier: NCT00730301     History of Changes
Other Study ID Numbers: EUROPT 07-074-0507
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: August 2008
Keywords provided by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology:
Chronic obstructive pulmonary disease
Lung volume reduction
Lung function
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Respiratory Tract Diseases
Pathologic Processes