UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009322 |
|---|---|
| Receipt number | R000010949 |
| Scientific Title | A survey of prognosis for idiopathic pulmonary fibrosis who receive long term oxygen therapy. |
| Date of disclosure of the study information | 2012/11/13 |
| Last modified on | 2024/06/20 22:10:42 |
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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 prognosis for IPF who receive LTOT.
Scientific Title
A survey of prognosis for idiopathic pulmonary fibrosis who receive long term oxygen therapy.
Scientific Title:Acronym
A survey of prognosis for IPF who receive LTOT.
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
Others
Basic objectives -Others
To grasp and analyze the current situation of the survival of patients with IPF receiving LTOT.
Trial characteristics_1
Confirmatory
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
IPF patients newly prescribed LTOT
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Kataoka |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
4898642
Address
160 Nishioiwake-cho, Seto city, 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
Department of Respiratory Medicine and Allergy
Zip code
4898642
Address
160 Nishioiwake-cho, Seto city, 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
Address
160 Nishioiwake-cho, Seto city, Aichi, Japan
Tel
0561-82-5101
shomu@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
| 2012 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10444790/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10444790/
Number of participants that the trial has enrolled
147
Results
The median survival of IPF patients after starting oxygen therapy is only about 1.5 years. Multivariable analysis at the time oxygen therapy is started revealed that low BMI, low FVC, low DLCO, low minimum SpO2 on 6MWT, and high CAT score were independent factors for a poor prognosis. In addition to pulmonary function tests, 6MWT and patient reported outcomes can be used to predict prognosis more accurately.
Results date posted
| 2024 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 22 | Day |
Baseline Characteristics
A total 147 IPF patients were included in the study, and the median length of follow-up was 479 days for all patients. The majority of patients were male (80%) with a median duration of IPF before enrollment of 46 months. Twenty-two (15%) patients had hypoxemia (SpO2 < 88%) at rest, and 124 (84%) had hypoxemia (SpO2 < 90%) on exertion. Of the 53 patients diagnosed with pulmonary hypertension, 9 were diagnosed by right heart catheter and the remaining 44 were diagnosed by echocardiography alone. Eighty-six (59%) patients were prescribed AOT and 61 (41%) were prescribed LTOT.
Participant flow
Participants were recruited from 19 Japanese hospitals with expertise in interstitial lung disease between December 2012 and November 2015.
Adverse events
None
Outcome measures
During the observation period, 113 patients died, and one underwent lung transplantation. Causes of death were chronic respiratory failure in 59 (52%), acute exacerbation in 31 (27%), and lung cancer in 5 (4%). The median survival from the start of oxygen therapy was 537 +/- 74 days.
Univariable Cox regression analysis demonstrated that lower FVC (p < 0.001), lower DLCO (p = 0.004), resting hypoxemia (SpO2 < 88%) (p = 0.006), shorter 6MWT distance (p = 0.010), and higher CAT score (p < 0.001), higher mMRC scale (p = 0.006), and higher GAP stage (p < 0.001) were significantly associated with poor prognosis. On the other hand, duration of IPF, presence of pulmonary hypertension, and meeting criteria for indication of oxygen therapy were not associated with prognosis. Multivariable analysis revealed that lower BMI (p = 0.008), lower FVC (p = 0.003), lower DLCO (p = 0.030), resting hypoxemia (SpO2 < 88%) (p = 0.034), lower minimum SpO2 on 6MWT (p = 0.004) and higher CAT (p = 0.021) were significantly associated with poor prognosis. In the other multivariable model, excluding DLCO, lower BMI (p = 0.028), lower FVC (p < 0.001), shorter 6MWT distance (p = 0.002), lower minimum SpO2 on 6MWT (p < 0.001), and higher CAT (p = 0.009) were significantly associated with poor prognosis.
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
| 2015 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No longer recruiting
Management information
Registered date
| 2012 | Year | 11 | Month | 12 | 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=R000010949
