UMIN-CTR Clinical Trial

Public title

Bronchoscopic Lung Volume Reduction with Lung Volume Reduction Coil

Acronym

LVRC trial

Scientific Title

Bronchoscopic Lung Volume Reduction with Lung Volume Reduction Coil

Scientific Title:Acronym

LVRC trial

Region

Japan

Condition

Chronic obstructive pulmonary disease (COPD)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the efficacy and safety of bronchoscopic lung volume reduction (BLVR) with LVRCs in order to introduce the treatment in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

1.Change in FEV1, SGRQ and 6MWT at 6 months after bilateral treatment
2.Adverse Events
Treatment-related serious adverse events mentioned below, occurring from start of treatment to one lung to 6 months after completion of the treatment:
(1)Pneumothorax with air leaks that continue for 7 or more days
(2)Acute exacerbation and respiratory infection requiring hospitalization or prolongation of hospitalization
(3)Respiratory failure that requires mechanical ventilation control for >=24 hours
(4)Hemoptysis (>=300 mL, or requires transfusion)
(5)Treatment-related deaths

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The placement of LVRC in the target lobe in the bilateral lung

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

35

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Subject has read, understood, and signed the informed consent form.
2.Subject is older than or equal to 35 years of age.
3.Computerized tomography (CT) scan indicates bilateral emphysema.
4.Subject has post-bronchodilator forced expiratory volume in first second (FEV1)<=45% predicted.
5.Subject has Total Lung Capacity (TLC)>100% predicted, and has residual volume (RV)>=175% predicted.
6.Subject has marked dyspnea>=2* on the modified Medical Research Council (mMRC) scale.
*mMRC grade 2 is defined as follows:On level ground, walk slower than people of same age because of breathlessness, or I have to stop for breath when walking at my own pace on the level.
7.Subject has declared that he/she has stopped smoking for at least 8 weeks prior to entering the study.
8.Subject is undergoing respiratory rehabilitation, and will continue treatment.
9.Subject is receiving optimal standard of care therapy for their emphysema, including pneumococcal and influenza vaccinations.

Key exclusion criteria

1.Extensive emphysema so that only a poor amount tissue can be rolled by LVRC
2.Co-morbidities (e.g.,orthopedic disease or significant cardiovascular disease) that significantly reduce his/her ability to walk, and therefore cannot perform the six-minute walk test (6MWT).
3.A change in FEV1>20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of >200 mL) post-bronchodilator unless the investigator can confirm by other means that subject does not have asthma.
4.%DLco<20%
5.PaO2<45Torr or PaCO2>=55 Torr
6.A history of recurrent clinically significant respiratory infections.
7.Severe pulmonary hypertension.
8.6MWD<=140m.
9.Serious disease that may compromise survival of the subject for the duration of the study.
10.Pregnant or lactating.
11.Not able to tolerate bronchoscopy.
12.Clinically significant bronchiectasis.
13.Giant bullae >=1/3rd one-lung volume.
14.HIstory of LVR surgery (including BLVR) or lobectomy.
15.Involved in pulmonary drug or device studies within 30 days prior to informed consent of the study.
16.Taking>=20 mg prednisone daily, or high-dose chronic immunosuppressive therapy.
17.Antiplatelet agent or anticoagulant therapy that cannot be stopped for 7 days prior to the procedure.
18. Sensitivity or allergy to nickel or other agents or devices used for bronchoscopic therapy.
19. Alpha-1 antitrypsin deficiency.
20.Any other condition that the investigator judges to exclude from the study.

Target sample size

5

Name of lead principal investigator

1st name	Masamichi
Middle name
Last name	Mineshita

Organization

St. Marianna University School of Medicine

Division name

Division of Respiratory Medicine, Department of Internal Medicine

Zip code

216-8511

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

TEL

044-977-8111

Email

m-mine@marianna-u.ac.jp

Name of contact person

1st name	Masamichi
Middle name
Last name	Mineshita

Organization

St. Marianna University School of Medicine

Division name

Division of Respiratory Medicine, Department of Internal Medicine

Zip code

216-8511

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

TEL

044-977-8111

Homepage URL

Email

m-mine@marianna-u.ac.jp

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Organization

St. Marianna University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the Institutional Review Board of St. Marianna University Hospital

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

Tel

044-977-8111

Email

k-sienbu.mail@marianna-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

01

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000026967

Publication of results

Published

URL related to results and publications

https://doi.org/10.18907/jjsre.41.1_C1

Number of participants that the trial has enrolled

1

Results

This is the first report for bronchoscopic lung volume reduction with LVRC in a patient with COPD in Japan. No serious adverse events occurred during procedures and clinical improvements were observed for exercise capacity and the subjective symptoms for this patient.

Results date posted

2022

Year

08

Month

03

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2019

Year

01

Month

25

Day

Baseline Characteristics

A 76-year-old man with severe COPD has been continuously treated at our outpatient department since 2009. His dyspnea symptoms were continued while undergoing triple therapy treatment and rehabilitation.

Participant flow

We performed bronchoscopic lung volume reduction with 12 LVRC (100mm 8, 125mm 4) that were implanted in the right lower lobe. Two months after the initial procedure, 11 LVRC (100mm 4, 125mm 7) were implanted in the left lower lobe.

Adverse events

No severe adverse events.

Outcome measures

Three months after the secondary procedure, the patients' six-minute walk distance improved by 75m and the Modified Medical Research Council dyspnea scale improved from 3 to 2.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

05

Month

02

Day

Date of IRB

2016

Year

05

Month

02

Day

Anticipated trial start date

2016

Year

08

Month

01

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

07

Month

30

Day

Last modified on

2022

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026967