UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001918
Receipt number R000002336
Scientific Title Prevention of early asthma in childhood trial with pranlukast in Mie; PROACT-Mie
Date of disclosure of the study information 2009/05/01
Last modified on 2018/09/19 15:14:35

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Basic information

Public title

Prevention of early asthma in childhood trial with pranlukast in Mie; PROACT-Mie

Acronym

Early intervention with pranlukast for recurrent wheeze in infants

Scientific Title

Prevention of early asthma in childhood trial with pranlukast in Mie; PROACT-Mie

Scientific Title:Acronym

Early intervention with pranlukast for recurrent wheeze in infants

Region

Japan


Condition

Condition

Wheezing syndrome in infants

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effect of a leukotriene receptor antagonist, pranlukast, for recurrent wheeze in infancy

Basic objectives2

Others

Basic objectives -Others

To investigate whether early intervention with pranlukast prevents progression of wheezing syndrome towards persistent asthma

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

wheezing episodes during and after treatment with pranlukast

Key secondary outcomes

rate of dropout because of persistent asthma symptoms


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

pranlukast and as-needed beta agonists

Interventions/Control_2

as-needed beta agonists

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

6 months-old <=

Age-upper limit

24 months-old >

Gender

Male and Female

Key inclusion criteria

recurrent wheeze more than once

Key exclusion criteria

Wheezing due to congenital anatomical anomaly, wheezing due to mediatinal neoplasm, croup syndrome, foreign body in the airways, heart diseases, pneumonia, tuberculosis, administration of leukotriene receptor antagonists, cromolyns, anti-histamines,
severe liver/renal/heart diseases

Target sample size

100


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

059-245-6355

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yuki Yamamoto

Organization

Mie National Hospital

Division name

Department of clinical trials

Zip code


Address

357 Osato-kubota, Tsu, Mie, Japan

TEL

059-245-6355

Homepage URL

http://www.mie-hosp.org

Email

fujisawa@mie-m.hosp.go.jp


Sponsor or person

Institute

Study group of pediatric asthma in Mie prefecture

Institute

Department

Personal name



Funding Source

Organization

Mie National Hospital

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2009 Year 05 Month 01 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

2005 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 11 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry

2011 Year 02 Month 01 Day

Date trial data considered complete

2011 Year 03 Month 01 Day

Date analysis concluded

2011 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 04 Month 29 Day

Last modified on

2018 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002336


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name