UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005346 |
|---|---|
| Receipt number | R000006352 |
| Scientific Title | Body composition and disease severity in idiopathic pulmonary fibrosis |
| Date of disclosure of the study information | 2011/03/31 |
| Last modified on | 2016/02/23 12:30:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Body composition and disease severity in idiopathic pulmonary fibrosis
Acronym
Body composition in IPF
Scientific Title
Body composition and disease severity in idiopathic pulmonary fibrosis
Scientific Title:Acronym
Body composition in IPF
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between body composition and disease severity in IPF
Basic objectives2
Others
Basic objectives -Others
Cross-sectional obserbation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Body composition
2) Pulmonary function test
3) Arterial blood gas analysis
4) 6-min walk test
Key secondary outcomes
1) Daily dyspnea (BDI, modified MRC)
2) Health-related quality of life (SGRQ)
3) Depression (HADS)
4) Mental status (MMSE)
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
1) Patients with IPF diagnosed with ATS/ERS/JRS/ALAT guideline 2011
2) Without any infection and acute exacerbation within 3 mo
3) Written informed consent
Key exclusion criteria
1) Patients with uncontrolled comorbidities
2) Patients who cannot undergo pulmonary function test and/or 6-min walk test
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Nishiyama |
Organization
Kinki University School of Medicine
Division name
Departement of Respiratory Medicine and Allergology
Zip code
Address
377-2 Onohigashi, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
nishi-o@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Nishiyama |
Organization
Kinki University School of Medicine
Division name
Departement of Respiratory Medicine and Allergology
Zip code
Address
377-2 Onohigashi, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
nishi-o@med.kindai.ac.jp
Sponsor or person
Institute
Departement of Respiratory Medicine and Allergology, Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2011 | Year | 03 | Month | 30 | Day |
Last modified on
| 2016 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006352
