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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020212
Receipt No. 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 2018/06/20

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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
Middle name
Last name Hiroyuki Taniguchi
Organization Tosei General Hospital
Division name Respiratory Medicine & Allergy
Zip code
Address 160 Nishioiwake-cho, Seto, Aichi, Japan
TEL 0561-82-5101
Email lung@tosei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Kataoka
Organization Tosei General Hospital
Division name Respiratory Medicine & Allergy
Zip code
Address 160 Nishioiwake-cho, Seto, Aichi, Japan
TEL 0561-82-5101
Homepage URL
Email kataoka@tosei.or.jp

Sponsor
Institute The Diffuse Lung Disease Group from the Ministry of Health,Labour and Welfare (Japan).
Institute
Department

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
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

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
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 No longer recruiting
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 13 Day
Last follow-up date
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
2018 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010879

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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