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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001918
Receipt No. 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

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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
Institute Study group of pediatric asthma in Mie prefecture
Institute
Department

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
URL(English) https://upload.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


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