UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044100
Receipt number R000048803
Scientific Title Phenotype specific identification of prediction factors for exacerbation of asthma and analysis of long-term prognosis -2020 cohort-
Date of disclosure of the study information 2021/05/03
Last modified on 2021/05/03 16:27:51

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Basic information

Public title

Phenotype specific identification of prediction factors for exacerbation of asthma and analysis of long-term prognosis -2020 cohort-

Acronym

Phenotype specific prognosis and prediction factor for exacerbation of asthma -2020 cohort-

Scientific Title

Phenotype specific identification of prediction factors for exacerbation of asthma and analysis of long-term prognosis -2020 cohort-

Scientific Title:Acronym

Phenotype specific prognosis and prediction factor for exacerbation of asthma -2020 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 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

Index date will be set and the relationship between clinical information, biomarkers at index date and future exacerbation, annual decline will be phenotype-specifically investigated.

Trial characteristics_1


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 with asthma, followed-up by participating facilities, and treated by inhaled corticosteroids are eligible. Spirometry and FeNO testing is essential.

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

500


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

1738605

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 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



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)



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

2032 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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048803


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name