UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Can early use of Salmeterol/Fluticasone control childhood asthma better than Fluticasone alone in long-term management?
Title of the study (Brief title)	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.

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

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

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	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	MURAI, HIROKI
Organization	Univerisity of Fukui
Division name	Pediatrics
Address	23-3 Matsuoka-ShimoAizuki Eiheiji-Cho, Fukui, JAPAN
TEL	+81-776-61-3111
Email

Public contact
Name of contact person
Organization	Univeristy of Fukui
Division name	Department of Pediatrics
Address	23-3 Matsuoka-ShimoAizuki Eiheiji-Cho, Fukui, JAPAN
TEL	(0776)61-3111
Homepage URL
Email

Sponsor
Institute	Department of Pediatrics University of Fukui
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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011748