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The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients

Primary Purpose

Pulmonary Emphysema

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endobronchial valve
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Emphysema focused on measuring COPD, Emphysema, Bronchoscopic lung volume reduction, Endobronchial valve

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endobronchial valve:

Arm Description

Endobronchial valve (size 4.0 - 7.0 mm or 5.5 - 8.5 mm) insertion for target bronchi

Outcomes

Primary Outcome Measures

Quantitative change of lung volume on computed tomography
Lung perfusion and ventilation computed tomography protocols

Secondary Outcome Measures

Pulmonary function test
Forced expiratory volume in 1s (FEV1), Forced vital capacity (FVC), Total lung capacity (TLC), Residual volume (RV)
Exercise capacity
Six-minute walk distance test
Healthcare quality of life
St. George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)

Full Information

First Posted
June 1, 2013
Last Updated
June 26, 2017
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01869205
Brief Title
The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients
Official Title
The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 caused by a mixture of small airway disease (obstructive bronchiolitis) and parenchyma destruction (emphysema). Bronchodilator and anti-inflammatory drugs, such as corticosteroids are effective to obstructive bronchiolitis. However, these drugs are not effective to emphysema. Lung volume reduction was devised to remove hyperinflated lung, and to function remaining lung. Surgical lung volume reduction showed improving survival in selected emphysema patients. However, surgical lung volume reduction have bee performed rarely due to significant surgery-related mortality. In this regard, non-surgical lung volume reduction methods have been developed. Of them, bronchoscopic lung volume reduction by endobronchial one-way valve is mostly used method and showed lower early complications than surgery. The bronchoscopic lung volume reduction using endobronchial valve was proved its efficacy and safety in several large clinical trials. Although there were procedure-related complications such as acute exacerbation of COPD, pneumonia, or hemoptysis, patients receiving endobronchial valves showed improved lung functions, exercise capacity and quality of life. The endobronchial valves got approved for Conformity to European (CE) Mark in Europe. In follow-up study for patients with endobronchial valves, their efficacy and survival of patients were dependent on atelectasis induced by valves. Collateral ventilation plays a key role in endobronchial valve-induced atelectasis. Therefore, assessment of collateral ventilation should be preceded before inserting endobronchial valve. Computed tomography (CT) can visualize and characterize morphologic change of lung of patients with COPD. Lung perfusion and ventilation CT protocols were developed for quantitative assessment of COPD before and after medical treatment. The CT protocols were expected to select optimal patients for endobronchial valves and to evaluate their efficacy. We attempt to evaluate efficacy of bronchoscopic lung volume reduction using lung perfusion and ventilation CT and other outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Emphysema
Keywords
COPD, Emphysema, Bronchoscopic lung volume reduction, Endobronchial valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Bronchoscopioc lung volume reduction by endobronchial valve
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endobronchial valve:
Arm Type
Experimental
Arm Description
Endobronchial valve (size 4.0 - 7.0 mm or 5.5 - 8.5 mm) insertion for target bronchi
Intervention Type
Device
Intervention Name(s)
Endobronchial valve
Other Intervention Name(s)
- EBV-TS-4.0 (Zephyr® 4.0), - EBV-TS-5.5 (Zephyr® 5.5)
Intervention Description
One-way endobronchial valves are placed in segmental bronchi of the most hyperinflated and least perfused lobe of the emphysematous lungs on computed tomography (CT). Before the procedure, we confirm that the target lobe has no collateral ventilation with other lobes using Chartis® System (Pulmonx, Inc. Redwood City, CA, USA).
Primary Outcome Measure Information:
Title
Quantitative change of lung volume on computed tomography
Description
Lung perfusion and ventilation computed tomography protocols
Time Frame
Before procedure and 12 weeks after procedure
Secondary Outcome Measure Information:
Title
Pulmonary function test
Description
Forced expiratory volume in 1s (FEV1), Forced vital capacity (FVC), Total lung capacity (TLC), Residual volume (RV)
Time Frame
Before procedure and 12 weeks after procedure
Title
Exercise capacity
Description
Six-minute walk distance test
Time Frame
Before procedure and 12 weeks after procedure
Title
Healthcare quality of life
Description
St. George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)
Time Frame
Before procedure and 12 weeks after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sei Won Lee, MD
Organizational Affiliation
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, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
12759479
Citation
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Results Reference
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PubMed Identifier
22005916
Citation
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Results Reference
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PubMed Identifier
22282552
Citation
Herth FJ, Noppen M, Valipour A, Leroy S, Vergnon JM, Ficker JH, Egan JJ, Gasparini S, Agusti C, Holmes-Higgin D, Ernst A; International VENT Study Group. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J. 2012 Jun;39(6):1334-42. doi: 10.1183/09031936.00161611. Epub 2012 Jan 26.
Results Reference
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PubMed Identifier
20947683
Citation
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Results Reference
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PubMed Identifier
20682529
Citation
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Results Reference
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PubMed Identifier
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Citation
Sciurba FC, Ernst A, Herth FJ, Strange C, Criner GJ, Marquette CH, Kovitz KL, Chiacchierini RP, Goldin J, McLennan G; VENT Study Research Group. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. 2010 Sep 23;363(13):1233-44. doi: 10.1056/NEJMoa0900928.
Results Reference
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PubMed Identifier
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Citation
Park TS, Hong Y, Lee JS, Oh SY, Lee SM, Kim N, Seo JB, Oh YM, Lee SD, Lee SW. Bronchoscopic lung volume reduction by endobronchial valve in advanced emphysema: the first Asian report. Int J Chron Obstruct Pulmon Dis. 2015 Jul 29;10:1501-11. doi: 10.2147/COPD.S85744. eCollection 2015.
Results Reference
derived
Links:
URL
http://www.copd-asthma.co.kr/Eng/
Description
Clinical Research Center for Chronic Obstructive Airway Disease (Korea)

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The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients

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