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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
