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

This study is currently recruiting participants.
Verified December 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Sei Won Lee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01869205
First received: June 1, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

To assess efficacy of bronchoscopic lung volume reduction in Korean emphysema patients


Condition Intervention Phase
Pulmonary Emphysema
Device: Endobronchial valve
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Quantitative change of lung volume on computed tomography [ Time Frame: Before procedure and 12 weeks after procedure ] [ Designated as safety issue: Yes ]
    Lung perfusion and ventilation computed tomography protocols


Secondary Outcome Measures:
  • Pulmonary function test [ Time Frame: Before procedure and 12 weeks after procedure ] [ Designated as safety issue: Yes ]
    Forced expiratory volume in 1s (FEV1), Forced vital capacity (FVC), Total lung capacity (TLC), Residual volume (RV)

  • Exercise capacity [ Time Frame: Before procedure and 12 weeks after procedure ] [ Designated as safety issue: Yes ]
    Six-minute walk distance test

  • Healthcare quality of life [ Time Frame: Before procedure and 12 weeks after procedure ] [ Designated as safety issue: Yes ]
    St. George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)


Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endobronchial valve:
Endobronchial valve (size 4.0 - 7.0 mm or 5.5 - 8.5 mm) insertion for target bronchi
Device: Endobronchial valve
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).
Other Names:
  • - EBV-TS-4.0 (Zephyr® 4.0)
  • - EBV-TS-5.5 (Zephyr® 5.5)

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01869205

Contacts
Contact: Sei Won Lee, MD +82-2-3010-3990 iseiwon@gmail.com

Locations
Korea, Republic of
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 Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sei Won Lee, MD    +82-2-3010-3990    iseiwon@gmail.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Sei Won Lee, MD 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
  More Information

Additional Information:
Publications:

Responsible Party: Sei Won Lee, 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, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01869205     History of Changes
Other Study ID Numbers: NSCR2013-0368, A102065
Study First Received: June 1, 2013
Last Updated: December 16, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
COPD
Emphysema
Bronchoscopic lung volume reduction
Endobronchial valve

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014