UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028154 |
|---|---|
| Receipt number | R000032223 |
| Scientific Title | Prognosis of asthma exacerbation in childhood with Modified Pulmonary Index Score |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2017/07/10 01:55:30 |
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Basic information
Public title
Prognosis of asthma exacerbation in childhood with Modified Pulmonary Index Score
Acronym
Prognosis of asthma exacerbation in childhood with Modified Pulmonary Index Score
Scientific Title
Prognosis of asthma exacerbation in childhood with Modified Pulmonary Index Score
Scientific Title:Acronym
Prognosis of asthma exacerbation in childhood with Modified Pulmonary Index Score
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate Modified Pulmonary Index Score(MPIS) of outpatient aged 1 to 18 year with asthma exacerbation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MPIS prognosing SpO2 92% or less
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with asthma exacerbation requiring inhaled bronchodilator
Key exclusion criteria
undiagnosed wheezing
fever up over 38.5
using antipyretics within 6 hours
sinusitis
cardiovascular malformation
chronis lung disease
rspiratory malformation
GERD
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Katsunuma |
Organization
Daisan hospital, Jikei university
Division name
Depertment of Pediatrics
Zip code
Address
4-11-1, Izumihoncho, Komae City, Tokyo
TEL
03-3480-1151
tkatsunuma@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Suzuki |
Organization
Jikei university
Division name
Depertment of Pediatrics
Zip code
Address
4-11-1, Izumihoncho, Komae City, Tokyo
TEL
03-3480-1151
Homepage URL
s.taka@jikei.ac.jp
Sponsor or person
Institute
Daisan hospital, Jikei university
Institute
Department
Personal name
Funding Source
Organization
Daisan hospital, Jikei university
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
| 2017 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | 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
Association between asthma exacerbation and Modified Pulmonary Index Score
Management information
Registered date
| 2017 | Year | 07 | Month | 10 | Day |
Last modified on
| 2017 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032223
