EUROPT Clinical Trial to Study the Efficacy of One-Way Valve Implantation (New Treatment Algorithm) in Patients With Heterogeneous Emphysema (EUROPT)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Emphysema Chronic Obstructive Pulmonary Disease||Procedure: Bronchoscopic Lung Volume Reduction (BLVR)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Procedure: Bronchoscopic Lung Volume Reduction (BLVR)
- Mean % change in lung function (FEV1) [ Time Frame: 90 days post index bronchoscopic lung volume reduction ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00730301
|Contact: Arschang Valipour, MDfirstname.lastname@example.org|
|Otto Wagner Hospital||Recruiting|
|Vienna, Austria, 1140|
|Contact: Arschang Valipour, MD email@example.com|
|Contact: Paul Germonpre, MD Paul.Germonpre@uza.be|
|Principal Investigator: Paul Germonpre, MD|
|Contact: Marc Meysman, MD Marc.Meysman@uzbrussel.be|
|Principal Investigator: Marc Meysman, MD|
|Principal Investigator:||Arschang Valipour, MD||Ludwig Boltzmann Institute for COPD|