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Recruitment status Completed
Unique ID issued by UMIN UMIN000006770
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email

Sponsor
Institute Dokkyo Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008008


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