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Completed

NCT Number: NCT01869205

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

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

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endobronchial Valve

Device

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)

Primary outcomes

  1. Quantitative change of lung volume on computed tomography

    Time frame: Before procedure and 12 weeks after procedure

    Lung perfusion and ventilation computed tomography protocols

Secondary outcomes

  1. Pulmonary function test

    Time frame: Before procedure and 12 weeks after procedure

    Forced expiratory volume in 1s (FEV1), Forced vital capacity (FVC), Total lung capacity (TLC), Residual volume (RV)

  2. Exercise capacity

    Time frame: Before procedure and 12 weeks after procedure

    Six-minute walk distance test

  3. Healthcare quality of life

    Time frame: Before procedure and 12 weeks after procedure

    St. George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Jun 5, 2013
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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