UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032194 |
|---|---|
| Receipt number | 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 | 2021/10/13 10:13:49 |
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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 | Mizuho |
| Middle name | |
| Last name | Nagao |
Organization
Mie National Hospital
Division name
Department of Clinical Research
Zip code
514-0125
Address
357 Osato-kubota, Tsu, Mie 514-0125, Japan
TEL
059-232-2531
nagao.mizuho.yt@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Tanimura |
Organization
Mie National Hospital
Division name
Department of Clinical Research
Zip code
514-0125
Address
357 Osato-kubota, Tsu, Mie 514-0125, Japan
TEL
059-232-2531
Homepage URL
mieclinicalresearch@gmail.com
Sponsor or person
Institute
National Hospital Organizationie, Mie National Hospital
Institute
Department
Personal name
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
National Hospital Organization Headquarters Clinical Research Central Ethics Review Committee
Address
2-5-21 Higashigaoka, Meguroku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.jp
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
No longer recruiting
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
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | 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
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035471
