UMIN-CTR Clinical Trial

Public title

Long-term noninvasive ventilation or oxygen therapy in patients with severe stable COPD: a multicenter observational study

Acronym

Long-term NIV or LTOT for stable COPD

Scientific Title

Long-term noninvasive ventilation or oxygen therapy in patients with severe stable COPD: a multicenter observational study

Scientific Title:Acronym

Long-term NIV or LTOT for stable COPD

Region

Japan

Condition

Chronic Obstructive Lung disease

Classification by specialty

Pneumology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the clinical benefit of long-term oxygen therapy or noninvasive ventilation in patients with severe COPD.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Changes in PaO2 (oxygen group) or PaCO2 (NIV group) before and after the treatment

Key secondary outcomes

1) Pulmonary function test
2) exercise tolerance (assessed by 6MWT)
3) physical activity (assessed by accelerometer)
4) Health-related QOL
5) Exacerabtions of COPD
6) Mortality

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Diagnosed as COPD and receives appropriate treatment for COPD (based on Japanese Guideline)
2) Indication for long-term oxygen therapy (LTOT) or NIV (based on Japanese health insurance or NIV guideline)
3) >10 years of smoking history
4) no changes in the treatments for COPD in the previous 4 weeks
5) clinically stable in the previous 4 weeks

Key exclusion criteria

1) pH <7.30 in ABG
2) current smoking
3) strongly suspected for sleep apnea (4%ODI [oxygen desaturation index 4%] >20)
4) chronic use of systemic glucocorticosteroids
5) pneumothorax in the previous 6 months
6) having other chronic pulmonary disease
7) clinically obvious heart failure
8) acute infection or malignancy
9) previous or current use of LTOT or NIV
10) pregnancy or lactation
11) other cases not suitable for the study

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Kazuo chin

Organization

Graduate School of Medicine, Kyoto University

Division name

Respiratory Care and Sleep Control Medicine

Zip code

Address

54 Shogoinkawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3852

Email

chink@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kimihiko Murase

Organization

Graduate School of Medicine, Kyoto University

Division name

Respiratory Medicine

Zip code

Address

54 Shogoinkawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3830

Homepage URL

Email

kmurase@kuhp.kyoto-u.ac.jp

Institute

Graduate School of Medicine, Kyoto University
Department of Respiratory Care and Sleep Control Medicine

Institute

Department

Personal name

Organization

JAPAN VASCULAR DISEASE RESEARCH FOUNDATION

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院（京都府）
日本大学医学部附属板橋病院（東京都）
大阪府立呼吸器・アレルギー医療センター（大阪府）
国立病院機構福岡病院（福岡県）
大阪回生病院 （大阪府）
奈良県立医科大学（奈良県）
信州大学医学部附属病院（長野県）
しんのクリニック（奈良県）
太田西ノ内病院（福島県）
国立病院機構福岡東医療センター　（福岡県）
千葉大学医学部附属病院（千葉県）
聖路加国際病院（東京都）
霧ヶ丘つだ病院（福岡県）
国立病院機構南京都病院（京都府）
近畿大学医学部附属病院（大阪府）
金沢医科大学病院（石川県）
神戸市立医療センター中央市民病院（兵庫県）
名嘉村クリニック（沖縄県）
虎の門病院（東京都）
平松内科・呼吸器科内科 （愛知県）
熊本中央病院 （熊本県）
慶応義塾大学医学部附属病院（東京都）
公立陶生病院 （愛知県）
いきいきクリニック（神奈川県）
大田病（東京都）
大津赤十字病院（滋賀県）
大阪赤十字病院（大阪府）
財団法人田附興風会医学研究所北野病院 （大阪府）
高槻赤十字病院（大阪府）
天理よろづ相談所（奈良県）
日本赤十字社和歌山医療センター（和歌山県）
神戸市立医療センター西市民病院（兵庫県）
国立病院機構姫路医療センター（兵庫県）
倉敷中央病院（岡山県）
国立病院機構東京病院 （東京都）
鹿児島大学 （鹿児島県）
東京女子医科大学八千代医療センター（東京都）

Date of disclosure of the study information

2015

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2014

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

01

Day

Last follow-up date

2018

Year

06

Month

01

Day

Date of closure to data entry

2018

Year

09

Month

01

Day

Date trial data considered complete

2018

Year

10

Month

01

Day

Date analysis concluded

2018

Year

12

Month

31

Day

Other related information

Study design
1. A prospective, multicenter, obserbational study
2. Method: To compare changes in ABG, exercise tolerance, physical activity, HRQOL etc. before and after LTOT or NIV treatment for patients with severe stable COPD
3. Randomization: None

Registered date

2014

Year

11

Month

06

Day

Last modified on

2017

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018138