UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010219 |
|---|---|
| Receipt number | R000011748 |
| Scientific Title | Can early use of Salmeterol/Fluticasone control childhood asthma better than Fluticasone alone in long-term management? |
| Date of disclosure of the study information | 2013/03/13 |
| Last modified on | 2016/04/25 20:47:19 |
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Basic information
Public title
Can early use of Salmeterol/Fluticasone control childhood asthma better than Fluticasone alone in long-term management?
Acronym
The effectiveness of early intervention with Salmeterol/Fluticasone in childhood asthma.
Scientific Title
Can early use of Salmeterol/Fluticasone control childhood asthma better than Fluticasone alone in long-term management?
Scientific Title:Acronym
The effectiveness of early intervention with Salmeterol/Fluticasone in childhood asthma.
Region
| Japan |
Condition
Condition
childhood asthma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop an effective use of salmeterol/fluticasone in long-term management of childhood asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The difference between total control ratio in SFC and FP in 12 weeks.
2. The difference between total control length in SFC and FP after 13 weeks.
Key secondary outcomes
1. The difference of improvement of inhaled NO and pulmonary function in SFC and FP.
2. The difference of use of full agonist of beta stimulant in SFC and FP.
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Salmeterol/fluticasone (SFC) group
Interventions/Control_2
fluticasone (FC) group
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
| 4 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The asthmatics between 4-11 years old of age, treated for 12weeks with LTRA treatment , and who is not well-controlled.
Key exclusion criteria
The patient who have :
1. congenital heart disease
2. chronic lung disease, or congenital lung disease.
3. premature baby born less than 34week
4. congenital annormaly
5. already using oral steroid
6 allergy to beta stimulants or inhaled steroid
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MURAI, HIROKI |
Organization
Univerisity of Fukui
Division name
Pediatrics
Zip code
Address
23-3 Matsuoka-ShimoAizuki Eiheiji-Cho, Fukui, JAPAN
TEL
+81-776-61-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Univeristy of Fukui
Division name
Department of Pediatrics
Zip code
Address
23-3 Matsuoka-ShimoAizuki Eiheiji-Cho, Fukui, JAPAN
TEL
(0776)61-3111
Homepage URL
Sponsor or person
Institute
Department of Pediatrics
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
department of pediatrics, University of Fukui
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
| 2013 | Year | 03 | Month | 13 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 10 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | Day |
Last modified on
| 2016 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011748
