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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008334
Receipt No. R000009811
Scientific Title Achieve Active life by Controlling EIA with optimal anti-inflammatory treatment for asthmatic Kids study
Date of disclosure of the study information 2012/07/03
Last modified on 2012/09/18

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Basic information
Public title Achieve Active life by Controlling EIA with optimal anti-inflammatory treatment for asthmatic Kids study
Acronym ACE kids study
Scientific Title Achieve Active life by Controlling EIA with optimal anti-inflammatory treatment for asthmatic Kids study
Scientific Title:Acronym ACE kids study
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate if optimal asthma controllers improve physical activity of children with exercise-induced asthma by controlling the exercise-induced symptoms
Basic objectives2 Others
Basic objectives -Others To investigate whether measurement of physical activity with an accelerometer can be utilized for objective assessment of treatment effect of anti-asthma drug for children with exercise-induced asthma
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes physical activity measured with an accelerometer
Key secondary outcomes maximal fall of forced expiratory volume 1.0 after exercise challenge

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/salmeterol combination inhaler
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
7 years-old <=
Age-upper limit
10 years-old >=
Gender Male
Key inclusion criteria more than 15% fall of FEV1 after exercise challenge with treadmill
Key exclusion criteria patients who have been treated with inhaled corticosteroids
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Fujisawa
Organization Mie National Hospital
Division name Institute for Clinical Research
Zip code
Address 357 Osato-kubota, Tsu, Mie, Japan
TEL 059-232-2531
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mizuho Nagao
Organization Mie National Hospital
Division name Institute for Clinical Research
Zip code
Address 357 Osato-kubota, Tsu, Mie, Japan
TEL 059-232-2531
Homepage URL
Email nagaomizuho@mie-m.hosp.go.jp

Sponsor
Institute Mie National Hospital
Institute
Department

Funding Source
Organization Clinical Research Support Center of Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 岩見沢こども・産科婦人科クリニック(北海道)、かわだ小児科アレルギークリニック(静岡県)、日本鋼管福山病院(広島県)、国立病院機構三重病院(三重県)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 03 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 Open public recruiting
Date of protocol fixation
2012 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
2013 Year 08 Month 01 Day
Date trial data considered complete
2013 Year 09 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 03 Day
Last modified on
2012 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009811

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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