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Pulmonary EmphysemaPhase 3NCT01869205

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

A Phase 3 study testing Endobronchial valve in people with Pulmonary Emphysema, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess efficacy of bronchoscopic lung volume reduction in Korean emphysema patients Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Pulmonary Emphysema
What is being tested?
Endobronchial valve
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteSouth Korea
Study dates
Mar 2013to Apr 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • 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

Other trials in South Korea

About this study

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

Read the 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.

Being tested
Endobronchial valve
Keywords
COPD, Emphysema, Bronchoscopic lung volume reduction, Endobronchial valve
Medical subject headings
Pulmonary Emphysema, Pulmonary Disease, Chronic Obstructive, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endobronchial valveDevice

    Also called - EBV-TS-4.0 (Zephyr® 4.0), - EBV-TS-5.5 (Zephyr® 5.5)

    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).

Study groups in NCT01869205
Study groupRoleWhat they receive
Endobronchial valve:ExperimentalEndobronchial valve (size 4.0 - 7.0 mm or 5.5 - 8.5 mm) insertion for target bronchi
Receives: Device: Endobronchial valve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative change of lung volume on computed tomography

    Lung perfusion and ventilation computed tomography protocols

    Measured: Before procedure and 12 weeks after procedure

Secondary outcomes (3)

  1. Pulmonary function test

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

    Measured: Before procedure and 12 weeks after procedure

  2. Exercise capacity

    Six-minute walk distance test

    Measured: Before procedure and 12 weeks after procedure

  3. Healthcare quality of life

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

    Measured: Before procedure and 12 weeks after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionApr 2014
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Bronchoscopioc lung volume reduction by endobronchial valve
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01869205
Sponsor's protocol ID
NSCR2013-0368
Other IDs
A102065
Status last verified
Jun 2017
First submitted
1 Jun 2013
Last updated
27 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12759479

  • 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.

    PubMed 22005916

  • 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.

    PubMed 22282552

  • 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.

    PubMed 20947683

  • 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.

    PubMed 20682529

  • 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.

    PubMed 20860505

  • 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.

    PubMed 26251590

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Endobronchial valve in people with Pulmonary Emphysema, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantitative change of lung volume on computed tomography (time frame: Before procedure and 12 weeks after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01869205, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.

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