UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008334
Receipt number 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 13:56:11

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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 or person

Institute

Mie National Hospital

Institute

Department

Personal name



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

Value
https://center6.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