UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005519 |
|---|---|
| Receipt number | R000006305 |
| Scientific Title | The role of long-term use of noninvasive ventilation in patients with severe chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2022/11/12 09:27:00 |
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Basic information
Public title
The role of long-term use of noninvasive ventilation in patients with severe chronic obstructive pulmonary disease
Acronym
The trial of long use of noninvasive ventilation for severe COPD
Scientific Title
The role of long-term use of noninvasive ventilation in patients with severe chronic obstructive pulmonary disease
Scientific Title:Acronym
The trial of long use of noninvasive ventilation for severe COPD
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the clinical effects of long-term use of noninvasive ventilation (NIV) in severe COPD patients accompanied by hypercapnia. The patients will be randomized to 'NIV group' and 'non NIV group' and the clinical outcomes will be compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood carbon dioxide level
Key secondary outcomes
Lung function(FEV1, FEV1/FVC)
6 minutes walk test
Health related QOL
The numbers of events of acute deterioration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
start nocturnal use of NIV. We set the pressure support as much as patients are tolerable.
Interventions/Control_2
continue the current treatments
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.He or she has to have the diagnosis of COPD.
2.more than 10 years smoking story
3.The current treatment should be continued more than 3 months
4.In pulmonary lung function test,FEV1/FVC less than 60% and FEV1 more than 1.5L
5.In arterial blood gas analysis PaCO2 more than 45mmHg and pH more than 7.30
6.clinicaly stable for more than 4 weeks
Key exclusion criteria
1.The patiens whose FEV1/FVC improved more than 15% with short acting bronchodailative agents.
2.current-smoker
3.The patients complicated with sleep apnea syndrome
4.patients taking regular systemic steriods
5.pneumothorax within 6 months
6.patients complicated with other choronic pulmonary syndromne
7.patients complicated with severe heart failure
8.patients complicated with infection and malignant diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kauo |
| Middle name | |
| Last name | Chin |
Organization
Kyoto University Graduated School of Medicine
Division name
Department of respiratory management and sleep control medicine
Zip code
606-8501
Address
54 Shougoinn-kawaharacho Sakyo Kyoto
TEL
81-75-751-3852
chink@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kimihiko |
| Middle name | |
| Last name | Murase |
Organization
Kyoto University Graduated School of Medicine
Division name
Depatment of respiratory medicine
Zip code
606-8501
Address
54 Shougoinn-kawaharacho Sakyo Kyoto
TEL
81-75-751-3852
Homepage URL
kmurase@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduated School of Medicine,Department of respiratory management and sleep control medicine
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine Ethics Comittee
Address
54 shogoin-kawaharacho sakyo Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
0
Results
We terminated the study because we could enroll the patients.
Results date posted
| 2022 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We terminated the study because we could enroll the patients.
Participant flow
We terminated the study because we could enroll the patients.
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 27 | Day |
Last modified on
| 2022 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006305
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
