UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023224 |
|---|---|
| Receipt number | R000026766 |
| Scientific Title | Inhibition of virus induced Aggravation of childhood asthma by Salmeterol/Fluticasone Propionate Combination(SFC) |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2025/12/11 09:37:17 |
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Basic information
Public title
Inhibition of virus induced Aggravation of childhood asthma by Salmeterol/Fluticasone Propionate Combination(SFC)
Acronym
Inhibition of virus induced Aggravation of childhood asthma by Salmeterol/Fluticasone Propionate Combination(SFC)
Scientific Title
Inhibition of virus induced Aggravation of childhood asthma by Salmeterol/Fluticasone Propionate Combination(SFC)
Scientific Title:Acronym
Inhibition of virus induced Aggravation of childhood asthma by Salmeterol/Fluticasone Propionate Combination(SFC)
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare the effects of the asthma of infants of the SFC and fluticasone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In patients with a common cold, asthma control was significantly more effective for those treated with SFC compared to treatment with Fluticasone
Key secondary outcomes
In 12th week SFC group will show higher Best ACT P score and QOL score than Fluticasone group.
SFC group will less freqently to use beta stimulator and less frequently to visit ER department.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We will give Fluticasone for 12 weeks.
Interventions/Control_2
We will give SFC for 12 weeks.
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
| 6 | months-old | <= |
Age-upper limit
| 24 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Physician diagnosed asthma(
More than 3 wheeze episode)
More than 2 asthma attacks for 8 weeks
LTRA is taken for more than 1month as a controller
Key exclusion criteria
SFC or Fluticasone is used as a controller
Patients has respiratory diseases except asthma
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigemi |
| Middle name | |
| Last name | Yoshihara |
Organization
Dokkyo Medical University
Division name
Department of
Zip code
321-0293
Address
880 Kitakobayashi, Mibumachi,
TEL
0282-86-1111
shigemi@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hayashi |
Organization
Tsukuba Medical Center Hospital
Division name
Department of Pediatrics
Zip code
305-8558
Address
1-3-1 Amakubo, Tsukuba, Ibaraki 305-8558, Japan
TEL
029-851-3511
Homepage URL
hayashi_daisuke@tmch.or.jp
Sponsor or person
Institute
Tsukuba Medical Center Hospital
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
Dokkyo Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Clinical Research Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
Tel
0285-58-7637
jmu-crb2020@jichi.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
Other administrative information
Date of disclosure of the study information
| 2016 | 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
33
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
| 2016 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026766
