Trial record 20 of 337 for:    Emphysema

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
ClinicalTrials.gov Identifier:
NCT00730301
First received: August 5, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 Intervention Phase
Emphysema
Chronic Obstructive Pulmonary Disease
Procedure: Bronchoscopic Lung Volume Reduction (BLVR)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Bronchoscopic Lung Volume Reduction (BLVR)
    Procedure under general anesthesia.
    Other Name: ZephyrTM Endobronchial Valve (EBV) (Emphasys Medical, Inc., Redwood City, CA)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730301

Contacts
Contact: Arschang Valipour, MD +43-1-91060-41833 arschang.valipour@wienkav.at

Locations
Austria
Otto Wagner Hospital Recruiting
Vienna, Austria, 1140
Contact: Arschang Valipour, MD       arschang.valipour@wienkav.at   
Belgium
University Antwerp Recruiting
Antwerp, Belgium
Contact: Paul Germonpre, MD       Paul.Germonpre@uza.be   
Principal Investigator: Paul Germonpre, MD         
University Brussels Recruiting
Brussels, Belgium
Contact: Marc Meysman, MD       Marc.Meysman@uzbrussel.be   
Principal Investigator: Marc Meysman, MD         
Sponsors and Collaborators
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Investigators
Principal Investigator: Arschang Valipour, MD Ludwig Boltzmann Institute for COPD
  More Information

No publications provided

Responsible Party: Arschang Valipour, M.D., Ludwig Boltzmann Institut for COPD
ClinicalTrials.gov Identifier: NCT00730301     History of Changes
Other Study ID Numbers: EUROPT 07-074-0507
Study First Received: August 5, 2008
Last Updated: August 5, 2008
Health Authority: Austria: Ethikkommission der Stadt Wien

Keywords provided by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology:
Emphysema
Chronic obstructive pulmonary disease
Lung volume reduction
Lung function

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014