Chronic Obstructive Pulmonary Disease Clinical Trial
— EUROPTOfficial 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
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.
Status | Unknown status |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Otto Wagner Hospital | Vienna | |
Belgium | University Antwerp | Antwerp | |
Belgium | University Brussels | Brussels |
Lead Sponsor | Collaborator |
---|---|
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology |
Austria, Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean % change in lung function (FEV1) | 90 days post index bronchoscopic lung volume reduction | ||
Secondary | 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. | 90 days post-index bronchoscopic lung volume reduction |
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