UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020212 |
|---|---|
| Receipt number | R000010879 |
| Scientific Title | A survey of prognosis for idiopathic pulmonary fibrosis who receive long term oxygen therapy. |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2024/06/20 22:22:43 |
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Basic information
Public title
A survey of prognosis for idiopathic pulmonary fibrosis who receive long term oxygen therapy.
Acronym
A survey of LTOT in patients with IPF.
Scientific Title
A survey of prognosis for idiopathic pulmonary fibrosis who receive long term oxygen therapy.
Scientific Title:Acronym
A survey of LTOT in patients with IPF.
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the survival of patients with idiopathic pulmonary fibrosis (IPF) receiving long term oxygen therapy (LTOT).
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the survival of patients with idiopathic pulmonary fibrosis (IPF) receiving long term oxygen therapy (LTOT).
Key secondary outcomes
To evaluate prognostic factor of patients with IPF receiving LTOT.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
IPF patients newly prescribed LTOT are enrolled.
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiyroyuki |
| Middle name | |
| Last name | Taniguchi |
Organization
Tosei General Hospital
Division name
Respiratory Medicine & Allergy
Zip code
489-8642
Address
160 Nishioiwake-cho, Seto, Aichi, Japan
TEL
0561-82-5101
lung@tosei.or.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Kataoka |
Organization
Tosei General Hospital
Division name
Respiratory Medicine & Allergy
Zip code
489-8642
Address
160 Nishioiwake-cho, Seto, Aichi, Japan
TEL
0561-82-5101
Homepage URL
kataoka@tosei.or.jp
Sponsor or person
Institute
The Diffuse Lung Disease Group from the Ministry of Health,Labour and Welfare (Japan).
Institute
Department
Personal name
Funding Source
Organization
The Diffuse Lung Disease Group from the Ministry of Health,Labour and Welfare (Japan).
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tosei General Hospital, IRB
Address
160 Nishioiwake-cho, Seto, Aichi, Japan
Tel
0561-82-5101
ychikenn@tosei.or.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
| 2015 | Year | 12 | Month | 15 | 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
147
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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational cohort study (completion of registration).
Registration period: from 13 Nov. 2012 to 30 Nov. 2015.
Objective: all patients who met criteria for and agreed with our protocol in multi institutions of The Diffuse Lung Disease Group from the Ministry of Health,Labour and Welfare (Japan).
Data collection at the time of enrollment: age, gender, BMI, pulmonary function tests, blood gas analysis, laboratory data, duration of IPF, CT, complicating disease, exercise capacity, desaturation, dyspnea, QOL, HAD and oxygen flow rate.
The end of the study: we will collect outcome at 30 Nov. 2018.
Management information
Registered date
| 2015 | Year | 12 | Month | 15 | Day |
Last modified on
| 2024 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010879
