Status:
COMPLETED
The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients
Lead Sponsor:
Asan Medical Center
Conditions:
Pulmonary Emphysema
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
To assess efficacy of bronchoscopic lung volume reduction in Korean emphysema patients
Detailed Description
The prevalence of chronic obstructive pulmonary disease (COPD) is high (13.4%). In addition, COPD ranked 10th among the causes of death in Korea, and rose to 7th in 2008. Airflow limitation of COPD is...
Eligibility Criteria
Inclusion
- Age more than 40 and below 75
- Patients with smoking history and heterogenous emphysema on chest CT
- Advanced emphysema (FEV1/FVC \<70%, FEV1 of 15-45%, TLC \>100% and RV \>150% predicted)
- Persistent symptoms refractory to treatment
- PaCO2 \<50 mmHg and PaO2 \>45 mmHg
- Body mass index (BMI) ≤31.1 kg/m2 (men) or ≤32.3 kg/m2 (women)
- 6-min walk distance \>140 m after pulmonary rehabilitation
Exclusion
- Diffusing capacity (DLco) \<20% predicted
- Large bullae (exceed 5 cm)
- Alpha-1 antitrypsin deficiency
- History of thoracotomy
- Excessive sputum production (throughout the week)
- Severe pulmonary hypertension ( systolic pulmonary artery pressure ≥ 45mmHg, estimated from the peak velocity of a tricuspid regurgitant jet by doppler echocardiography)
- Acute respiratory infection
- Unstable angina, congestive heart failure, or acute myocardial infarction in 6 months
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01869205
Start Date
March 1 2013
End Date
April 1 2017
Last Update
June 27 2017
Active Locations (1)
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1
Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea, 138-736