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

NCT01869205 | Completed Phase 3 DMC

• 2 other identifiers: NSCR2013-0368A102065
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Emphysema

Keywords

COPD; Emphysema; Bronchoscopic lung volume reduction; Endobronchial valve

Outcome Measures

Primary Outcomes (1)

• Quantitative change of lung volume on computed tomography

  Lung perfusion and ventilation computed tomography protocols

  Before procedure and 12 weeks after procedure

Secondary Outcomes (3)

• Pulmonary function test

  Before procedure and 12 weeks after procedure

• Exercise capacity

  Before procedure and 12 weeks after procedure

• Healthcare quality of life

  Before procedure and 12 weeks after procedure

Study Arms (1)

Endobronchial valve:

EXPERIMENTAL

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

Device: Endobronchial valve

Interventions

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).

Also known as: - EBV-TS-4.0 (Zephyr® 4.0), - EBV-TS-5.5 (Zephyr® 5.5)

Endobronchial valve:

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• min walk distance \>140 m after pulmonary rehabilitation

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (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, 138-736, South Korea

Location

Related Publications (7)

• 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. doi: 10.1056/NEJMoa030287. Epub 2003 May 20.

  PMID: 12759479 BACKGROUND

• 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.

  PMID: 22005916 BACKGROUND

• 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.

  PMID: 22282552 BACKGROUND

• 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.

  PMID: 20947683 BACKGROUND

• 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.

  PMID: 20682529 BACKGROUND

• 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.

  PMID: 20860505 BACKGROUND

• 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.

  PMID: 26251590 DERIVED

MeSH Terms

Conditions

Pulmonary Emphysema; Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: Bronchoscopioc lung volume reduction by endobronchial valve

Study Record Dates

• First Submitted: June 1, 2013
• First Posted: June 5, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

KR (1)