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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032194
Receipt No. R000035471
Scientific Title Identification of Predictive Phenotypes for Development of Asthma in 1-Year-Old Children with Recurrent Wheeze (Phenotyping of wheezing infants; P-WIN study)
Date of disclosure of the study information 2018/04/12
Last modified on 2019/08/15

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Basic information
Public title Identification of Predictive Phenotypes for Development of Asthma
in 1-Year-Old Children with Recurrent Wheeze
(Phenotyping of wheezing infants; P-WIN study)
Acronym P-WIN study
Scientific Title Identification of Predictive Phenotypes for Development of Asthma
in 1-Year-Old Children with Recurrent Wheeze
(Phenotyping of wheezing infants; P-WIN study)
Scientific Title:Acronym P-WIN study
Region
Japan Asia(except Japan)

Condition
Condition infantile wheeze
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate outcome of 1-year-old children with recurrent wheeze
Basic objectives2 Others
Basic objectives -Others To clarify the (short-term) prognosis of recurrent wheeze in children aged 1 year by prospectively following the outcomes under various treatment in real world settings and to establish a new classification of wheezing phenotypes based on the common medical practice in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Remission of wheezing symptoms 2 years after enrollment
Key secondary outcomes Physical exam, family history, environment (e.g., pets, passive smoking), infection, allergen sensitization, rhinitis symptoms, and phenotypic classification of wheezing according to drug used
Biomarkers by phenotypic class (e.g., serum EDN, periostin, SCCA2)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
12 months-old <=
Age-upper limit
24 months-old >
Gender Male and Female
Key inclusion criteria 1) At least one episode of wheeze before more than 1 month prior to enrollment
2) Apparent expiratory wheeze persisting for more than 24 h at enrollment
Key exclusion criteria 1) Wheezing due to underlying disease other than asthma (e.g., congenital tracheal stenosis, tracheomalacia, heart diseases)
2) History of respiratory diseases requiring mechanical ventilation during the perinatal period
3) Immunocompromised children
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mizuho Nagao
Organization Mie National Hospital
Division name Department of Clinical Research
Zip code
Address 357 Osato-kubota, Tsu, Mie 514-0125, Japan
TEL 059-232-2531
Email watersail711@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mie Murakoshi
Organization Mie National Hospital
Division name Department of Clinical Research
Zip code
Address 357 Osato-kubota, Tsu, Mie 514-0125, Japan
TEL 059-232-2531
Homepage URL
Email mieclinicalresearch@gmail.com

Sponsor
Institute Mie National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
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 国立病院機構三重病院(三重県)、国立病院機構仙台医療センター (宮城県)、国立病院機構下志津病院(千葉県)、国立病院機構横浜医療センター(神奈川県)、国立病院機構神奈川病院(神奈川県)、国立病院機構相模原病院(神奈川県)、国立病院機構栃木医療センター(栃木県)、国立病院機構名古屋医療センター(愛知県)、国立病院機構長良医療センター(岐阜県)、国立病院機構南岡山医療センター(岡山県)、国立病院機構福山医療センター(広島県)、国立病院機構四国こどもとおとなの医療センター(香川県)、国立病院機構高知病院(高知県)、国立病院機構熊本医療センター(熊本県)、国立病院機構南九州病院(鹿児島県)、国立病院機構福岡病院(福岡県)、国立病院機構福岡東医療センター(福岡県)、群馬県立小児医療センター(群馬県)、岩見沢こども・産科婦人科クリニック(北海道)、 まつだ小児科クリニック (三重県)、熱田小児科クリニックアレルギークリニック(三重県)、あおぞら小児科(鹿児島県)、大阪はびきの医療センター(大阪府)、福岡市立こども病院(福岡県)、昭和大学病院(東京都)、杢保小児科医院(香川県)、井手小児科(福岡県)、Manna&Babyこどもクリニック(福岡県)、井上四郎小児科(福岡県)、寺本こどもクリニック(岐阜県)、東京女子医科大学 東医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 12 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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 23 Day
Date of IRB
2018 Year 01 Month 22 Day
Anticipated trial start date
2018 Year 04 Month 12 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
2021 Year 05 Month 31 Day
Date trial data considered complete
2021 Year 06 Month 30 Day
Date analysis concluded
2021 Year 09 Month 30 Day

Other
Other related information 1) Analysis of the primary variables:
The proportion of patients with remission of wheezing symptoms after 2 years of enrollment will be calculated.
2) Analysis of the secondary variables:
Hierarchical cluster analysis using information at entry and 2 years
after enrollment, treatment administered and wheezing symptoms during the study period. Appropriate number clusters will be identified through construction of a dendrogram.
For each selected cluster, descriptive statistics of demographics of the subjects will be performed. The variables will be compared between clusters using analysis of variance, chi-square test or Kruskal-Wallis test. Descriptive statistics of biomarkers in each cluster will be calculated. Values of biomarkers will be compared between clusters using analysis of variance, chi-square test, or Kruskal-Wallis test.

Management information
Registered date
2018 Year 04 Month 11 Day
Last modified on
2019 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035471

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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