UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005201 |
|---|---|
| Receipt number | R000006177 |
| Scientific Title | Comparison of efficacy of budesonide dry powder inhaler and fuluticasone propionate dry powder inhaler in asthmatic children.-same dose study- |
| Date of disclosure of the study information | 2011/03/08 |
| Last modified on | 2011/03/06 15:38:20 |
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Basic information
Public title
Comparison of efficacy of budesonide dry powder inhaler and fuluticasone propionate dry powder inhaler in asthmatic children.-same dose study-
Acronym
Comparison of efficacy of budesonide dry powder inhaler and fuluticasone propionate dry powder inhaler -same dose study-
Scientific Title
Comparison of efficacy of budesonide dry powder inhaler and fuluticasone propionate dry powder inhaler in asthmatic children.-same dose study-
Scientific Title:Acronym
Comparison of efficacy of budesonide dry powder inhaler and fuluticasone propionate dry powder inhaler -same dose study-
Region
| Japan |
Condition
Condition
asthmatic children
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparisone of differene of efficacy between budesonide(DPI) and fluticasone(DPI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lung function
Nitric Oxide Level
Japanese Pediatric Asthma Control Program
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
start at inhalation of fluticasone propionate
Interventions/Control_2
start at inhalation of budesonide
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 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
children without inhalation corticosteroid during 6 months
Key exclusion criteria
children with pulmonary disorders, nurological diorders and other basic disorders.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukinori Yoshida |
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name
Pediatrics
Zip code
Address
3-7-1 Habikino Habikino city Osaka 583-8588 Japan
TEL
072-957-2121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name
Pediatrics
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Institute
Department
Personal name
Funding Source
Organization
no funding source
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
| 2011 | Year | 03 | Month | 08 | 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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
Management information
Registered date
| 2011 | Year | 03 | Month | 06 | Day |
Last modified on
| 2011 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006177
