Status:
UNKNOWN
EUROPT Clinical Trial to Study the Efficacy of One-Way Valve Implantation (New Treatment Algorithm) in Patients With Heterogeneous Emphysema
Lead Sponsor:
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Conditions:
Emphysema
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
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 heterog...
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. Tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00730301
Start Date
July 1 2007
Last Update
August 8 2008
Active Locations (3)
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1
Otto Wagner Hospital
Vienna, Vienna, Austria, 1140
2
University Antwerp
Antwerp, Belgium
3
University Brussels
Brussels, Belgium