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

Pulmonary Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869205
• Other study ID #: NSCR2013-0368
• Secondary ID: A102065
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2013
• Last updated: June 26, 2017
• Start date: March 2013
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2017
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

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).

Locations

Country	Name	City	State
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	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Berger RL, Decamp MM, Criner GJ, Celli BR. Lung volume reduction therapies for advanced emphysema: an update. Chest. 2010 Aug;138(2):407-17. doi: 10.1378/chest.09-1822. — View Citation

Fishman A, Martinez F, Naunheim K, Piantadosi S, Wise R, Ries A, Weinmann G, Wood DE; National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. 2003 May 22;348(21):2059-73. Epub 2003 May 20. — View 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. — View Citation

Hopkinson NS, Kemp SV, Toma TP, Hansell DM, Geddes DM, Shah PL, Polkey MI. Atelectasis and survival after bronchoscopic lung volume reduction for COPD. Eur Respir J. 2011 Jun;37(6):1346-51. doi: 10.1183/09031936.00100110. Epub 2010 Oct 14. — View 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. — View Citation

Venuta F, Anile M, Diso D, Carillo C, De Giacomo T, D'Andrilli A, Fraioli F, Rendina EA, Coloni GF. Long-term follow-up after bronchoscopic lung volume reduction in patients with emphysema. Eur Respir J. 2012 May;39(5):1084-9. doi: 10.1183/09031936.00071311. Epub 2011 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative change of lung volume on computed tomography	Lung perfusion and ventilation computed tomography protocols	Before procedure and 12 weeks after procedure
Secondary	Pulmonary function test	Forced expiratory volume in 1s (FEV1), Forced vital capacity (FVC), Total lung capacity (TLC), Residual volume (RV)	Before procedure and 12 weeks after procedure
Secondary	Exercise capacity	Six-minute walk distance test	Before procedure and 12 weeks after procedure
Secondary	Healthcare quality of life	St. George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)	Before procedure and 12 weeks after procedure

External Links

•   Asian Network for Obstructive Lung Disease
•   Clinical Research Center for Chronic Obstructive Airway Disease (Korea)