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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044099
Receipt No. 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 2021/05/03

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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
Email 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
Email nagaseh@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2021 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048802

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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