UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011142 |
|---|---|
| Receipt number | R000013019 |
| Scientific Title | Assessment of Health Related Quality of Life by SGRQ-I in patients with idiopathic pulmonary fibrosis |
| Date of disclosure of the study information | 2013/07/08 |
| Last modified on | 2018/07/12 13:53:09 |
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Basic information
Public title
Assessment of Health Related Quality of Life by SGRQ-I in patients with idiopathic pulmonary fibrosis
Acronym
Assessment of SGRQ-I in IPF
Scientific Title
Assessment of Health Related Quality of Life by SGRQ-I in patients with idiopathic pulmonary fibrosis
Scientific Title:Acronym
Assessment of SGRQ-I in 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 usefulness of SGRQ-I and blood biomarkers in the longitudinal assessment of disease severity in patients with idiopathic pulmonary fibrosis.
Basic objectives2
Others
Basic objectives -Others
Association between severity and HRQL in IPF
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores of SGRQ-I
Serum MMP7 concentrations
Key secondary outcomes
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
Patients diagnosed with idiopathic pulmonary fibrosis based on guidelines of an official ATS/ERS/JRS/ALAT statement. Regardless of treatment history.
Key exclusion criteria
Exclusion criteria included: (1) Patients with complication of malignant disease. But, the patients keeping remission for more than three years are eligible. ; (2) Patients with psychiatric disease or unstable mental status. (3) Patients with acute exacerbation of IPF, respiratory infection, or pneumothorax within 4 weeks.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyohiro Hirai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Medicine
Zip code
Address
54, Kawahara-cho, Hyogoin, Sakyo-ku, Kyoto-city, Kyoto
TEL
075-751-3830
t_hirai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Handa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Medicine
Zip code
Address
54, Kawahara-cho, Hyogoin, Sakyo-ku, Kyoto-city, Kyoto
TEL
075-751-3830
Homepage URL
hanta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
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
京都大学医学部附属病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
mMRC dyspnea scale, the HADS anxiety or depression, and minimum oxygen saturation during a six-minute walk test significantly contributed to the Total and three components of the SGRQ-I. In multivariate Cox proportional-hazards analyses, the Total score of SGRQ-I predicted clinical deterioration independent of forced vital capacity, the six-minute walk distance, or partial pressure of arterial oxygen on room air.
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
| 2013 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 26 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 26 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 26 | Day |
Other
Other related information
Longitudinal assessment of SGRQ-I in patients with idiopathic pulmonary fibrosis.
Management information
Registered date
| 2013 | Year | 07 | Month | 07 | Day |
Last modified on
| 2018 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013019
