UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030830 |
|---|---|
| Receipt number | R000035189 |
| Scientific Title | Steroids inhalation therapy in chronic eosinophilic pneumonia |
| Date of disclosure of the study information | 2018/01/16 |
| Last modified on | 2018/01/16 09:44:00 |
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Basic information
Public title
Steroids inhalation therapy in chronic eosinophilic pneumonia
Acronym
Eosinophilic pneumonia
Scientific Title
Steroids inhalation therapy in chronic eosinophilic pneumonia
Scientific Title:Acronym
Eosinophilic pneumonia
Region
| Japan |
Condition
Condition
Eosinophilic pneumonia
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine lebel and site of inflamation in lung.
Basic objectives2
Others
Basic objectives -Others
Efficacy of ICS in Eosinophilic Pnemonia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CD25 expression on CD4-positive T-lymphocytes was also increased (25.5 %) in the BALF compared to that on those in the peripheral blood (15.5 %).
Key secondary outcomes
We tried many ICSs on remmission and acute phase but obtained enough effect in eosinophilic pneumonia.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
In December 1999, a 15-year-old girl was referred to Habikino hospital for evaluation of respiratory symptoms. BALF, Peripheral blood.process of treatments with ICS.
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
Female
Key inclusion criteria
Eosinophilic pneumonia, a case report.
Key exclusion criteria
Nothing
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihide Murayama |
Organization
Murayama Pediatrics
Division name
Pediatrics
Zip code
Address
3-2-33 Nagayoshi-Nagahara-Higashi Hirano-ku Osaka-shi Osaka Japan
TEL
06-6790-8835
norihide99@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihide Murayama |
Organization
Murayama Pediatrics
Division name
Pediatrics
Zip code
Address
3-2-33 Nagayoshi-Nagahara-Higashi Hirano-ku Osaka
TEL
06-6790-8835
Homepage URL
norihide99@yahoo.co.jp
Sponsor or person
Institute
Murayama Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Murayama Pediatrics
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 01 | Month | 16 | 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
Eosinophils were increased in both the BALF (65 %) and peripheral blood (33 %). HLADR expression was increased on CD4-positive T-lymphocytes in the BALF (62.8 %) compared to that on those in the peripheral blood (6.4 %). CD25 expression on CD4-positive T-lymphocytes was also increased (25.5 %) in the BALF compared to that on those in the peripheral blood (15.5 %).
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
| 1999 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 1999 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2004 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2004 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2004 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2004 | Year | 07 | Month | 31 | Day |
Other
Other related information
We tried some ICS therapies for more than ten years. But I could not gain expected effect by any inhaled steroids.
Management information
Registered date
| 2018 | Year | 01 | Month | 16 | Day |
Last modified on
| 2018 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035189
