UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044099 |
|---|---|
| Receipt number | R000048802 |
| Scientific Title | Phenotype specific identification of prediction factors for exacerbation of asthma and analysis of long-term prognosis -2014 cohort- |
| Date of disclosure of the study information | 2021/05/03 |
| Last modified on | 2025/05/02 16:58:52 |
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Basic information
Public title
Phenotype specific identification of prediction factors for exacerbation of asthma and analysis of long-term prognosis -2014 cohort-
Acronym
Phenotype specific prognosis and prediction factor for exacerbation of asthma -2014 cohort-
Scientific Title
Phenotype specific identification of prediction factors for exacerbation of asthma and analysis of long-term prognosis -2014 cohort-
Scientific Title:Acronym
Phenotype specific prognosis and prediction factor for exacerbation of asthma -2014 cohort-
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Japanese asthma cohort established in 2014 will be investigated for long term to investigate the following objectives.
1. To clarify the long-term prognosis stratified by phenotype of asthma.
2. To investigate the phenotype-specific prognostic factors for exacerbation frequency and decline in pulmonary function.
3. To investigate the long-term prognosis of patients treated by biologics.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of annual exacerbation frequency stratified by phenotypes of asthma
Key secondary outcomes
1. Time course of ACT score, pulmonary function, biomarkers (blood eosinophil counts, total IgE, FeNO) stratified by phenotypes of asthma
2. Prognostic factors for exacerbation frequency and annual decline in FEV1
3. Improvement in exacerbation frequency, ACT sore, and pulmonary function after introduction of biologics in patients treated by antibody therapies
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients participated in 2014 cohort, still followed-up by participating facilities, and treated by inhaled corticosteroids are eligible.
Key exclusion criteria
Patients treated by unapproved drugs for clinical studies.
Patients judged as inappropriate for participating to the study by investigators.
Target sample size
372
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nagase |
Organization
Teikyo University School of Medicine
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-0003 Japan
TEL
03-3964-1211
nagaseh@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | HIroyuki |
| Middle name | |
| Last name | Nagase |
Organization
Teikyo University School of Medicine
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-0003 Japan
TEL
03-3964-1211
Homepage URL
nagaseh@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
KAGOSHIMA University(Kagoshima),National Hospital Organization Tokyo National Hospital(Tokyo),Fukushima Medical University Hospital(Fukushima),Showa University(Tokyo),JUNTENDO Uiversity(Tokyo),KINDAI University(Oosaka),KANAZAWA University(Ishikawa),University of TSUKUBA (Ibaraki)
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-0003 Japan
Tel
03-3964-7256
turb-office@teikyo-u.ac.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
帝京大学(東京都）、鹿児島大学（鹿児島県）、独立行政法人国立病院機構東京病院（東京都）、福島県立医科大学附属病院（福島県）、昭和大学医学部（東京都）、順天堂大学医学部（東京都）、近畿大学医学部（大阪府）、金沢大学医薬保健研究域（石川県）、筑波大学人間総合科学研究科（茨城県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 03 | 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
| 2020 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sampling at study entry: Serum (from 10 ml of whole blood)
Information collected every year: ACT score, exacerbation history, treatment drugs
Information collected every other year: pulmonary function testing, blood eosinophil count, serum IgE, FeNO
Management information
Registered date
| 2021 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048802
