UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006770 |
|---|---|
| Receipt number | R000008008 |
| Scientific Title | Usefulness of salmeterol/fluticasone combination (SFC) therapy in preschool children with uncontrolled asthma treated with inhaled corticosteroid. |
| Date of disclosure of the study information | 2011/11/25 |
| Last modified on | 2014/11/26 11:20:54 |
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Basic information
Public title
Usefulness of salmeterol/fluticasone combination (SFC) therapy in preschool children with uncontrolled asthma treated with inhaled corticosteroid.
Acronym
Usefulness of salmeterol/fluticasone combination (SFC) therapy in preschool children with uncontrolled asthma treated with inhaled corticosteroid.
Scientific Title
Usefulness of salmeterol/fluticasone combination (SFC) therapy in preschool children with uncontrolled asthma treated with inhaled corticosteroid.
Scientific Title:Acronym
Usefulness of salmeterol/fluticasone combination (SFC) therapy in preschool children with uncontrolled asthma treated with inhaled corticosteroid.
Region
| Japan |
Condition
Condition
Preschool children with asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal effectiveness of SFC50(pMDI) therapy in preschool childhood asthma (6months to 5years).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Nighttime awakening
Key secondary outcomes
Asthma symptom score
Asthma control questionnaire for preschool child
QOL questionnaire for parent
Number of SABA use
Number of unscheduled Doctor visit
Frequency of exacerbations with viral infection
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fluticasone propionate 50mcg aerosol, 2puff twice daily, for 4weeks to 8weeks.
Or beclomethasone dipropionate 50mcg aerosol, 1puff twice daily, for 4weeks to 8weeks.
Or ciclesonide 100mcg inhaler, 1puff once daily, for 4weeks to 8weeks.
Or budesonide inhalation suspension 0.25mg, nebulized once daily, for 4weeks to 8weeks.
Salmeterol / fluticasone propionate combination (SFC25/125mcg) aerosol, 2puff twice daily, for 12weeks.
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
| 0 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Preschool childhood asthma aged 6 months to 5 years. Gender does not matter.
2)A signed and dated written informed consent is obtained prior to participation from the parent.
Key exclusion criteria
1)Patients already treated with SFC.
2)Use inhaled, patch, and oral bronchodilator as long-term management (controller).
3)Patients have hypersensitivity to salmeterol or fluticasone propionate, or suspected patient.
4)The patients who are inappropriate considered by physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigemi Yoshihara |
Organization
Dokkyo Medical University
Division name
Department of Pediatrics
Zip code
Address
810 Kitakobayashi, Mibu-machi, Simotsuga-gun, Tochigi, 321-0293 Japan
TEL
0282-86-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigemi Yoshihara |
Organization
Dokkyo Medical University
Division name
Department of Pediatrics
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Dokkyo Medical University
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
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 | 11 | Month | 25 | 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
| 2011 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 25 | Day |
Last modified on
| 2014 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008008
