UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015615
Receipt number R000018138
Scientific Title Long-term noninvasive ventilation or oxygen therapy in patients with severe stable COPD: a multicenter observational study
Date of disclosure of the study information 2015/01/01
Last modified on 2017/05/09 10:50:31

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Basic information

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

Condition

Chronic Obstructive Lung disease

Classification by specialty

Pneumology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

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

Institute

Department

Personal name



Funding Source

Organization

JAPAN VASCULAR DISEASE RESEARCH FOUNDATION

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

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)


Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

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


Management information

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name