UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051398 |
|---|---|
| Receipt number | R000058637 |
| Scientific Title | A retrospective observational study of the occurrence of pneumothorax and/or pneumomediastinum in patients with interstitial lung diseases treated with antifibrotic drugs |
| Date of disclosure of the study information | 2023/06/21 |
| Last modified on | 2023/06/21 11:22:07 |
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Basic information
Public title
A retrospective observational study of the occurrence of pneumothorax and/or pneumomediastinum in patients with interstitial lung diseases treated with antifibrotic drugs
Acronym
Pneumothorax and/or pneumomediastinum in patients with interstitial lung diseases treated with antifibrotic drugs
Scientific Title
A retrospective observational study of the occurrence of pneumothorax and/or pneumomediastinum in patients with interstitial lung diseases treated with antifibrotic drugs
Scientific Title:Acronym
Pneumothorax and/or pneumomediastinum in patients with interstitial lung diseases treated with antifibrotic drugs
Region
| Japan |
Condition
Condition
interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the development of pneumothorax and/or pneumomediastinum in patients with interstitial lung diseases treated with antifibrotic drugs, and to determine whether antifibrotic drugs administration is associated with refractory pneumothorax and pneumomediastinum.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of pneumothorax and/or pneumomediastinum in patients with interstitial lung diseases treated with antifibrotic drugs
Key secondary outcomes
Rate of refractory pneumothorax and/or pneumomediastinum in patients with interstitial lung diseases treated with antifibrotic drugs
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
Patients with interstitial lung diseases who received the antifibrotic drugs, nintedanib or pirfenidone, at Kochi University Hospital from December 1, 2008 to September 30, 2022
Key exclusion criteria
None
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ohnishi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Respiratory Medicine and Allergology
Zip code
783-8505
Address
Kohasu 185-1, Oko-Cho, Nankoku, Kochi, Japan
TEL
088-880-2345
honi@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ohnishi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Respiratory Medicine and Allergology
Zip code
783-8505
Address
Kohasu 185-1, Oko-Cho, Nankoku, Kochi, Japan
TEL
088-880-2345
Homepage URL
honi@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi 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
The ethical review board of Kochi Medical School
Address
Kohasu 185-1, Oko-Cho, Nankoku, Kochi, Japan
Tel
088-880-2180
is21@kochi-u.ac.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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 21 | 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
70
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
| 2022 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient information (sex, age, height, weight, BMI, smoking history), Type of interstitial lung diseases, age at onset of interstitial lung diseases, history of corticosteroid administration, history of acute exacerbations, antifibrotic drugs (type, dosage, duration of administration), respiratory function test results, blood test results (albumin, HbA1c, CRP, LDH, KL-6, SP-A, SP-D ), chest high-resolution CT findings, presence or absence of home oxygen therapy, presence or absence of pneumothorax or pneumomediastinum (before, during, and after discontinuation of antifibrotic therapy), number of days until pneumothorax or pneumomediastinum heals, treatment for pneumothorax, and survival.
Management information
Registered date
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058637
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| Registered date | File name |
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