UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040839
Receipt number R000046627
Scientific Title Study on the effects of long-term respiratory function prognosis in bronchial asthma
Date of disclosure of the study information 2020/06/22
Last modified on 2020/06/20 16:45:50

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Basic information

Public title

Study on the effects of long-term respiratory function prognosis in bronchial asthma

Acronym

Study on the effects of long-term respiratory function prognosis in bronchial asthma

Scientific Title

Study on the effects of long-term respiratory function prognosis in bronchial asthma

Scientific Title:Acronym

Study on the effects of long-term respiratory function prognosis in bronchial asthma

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of long-term treatment prognosis on patients with asthma based on physiological items.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pulmonary function at baseline, after 1, 3 and 5 years.

Key secondary outcomes

Peripheral blood, IgE, FeNO, CT findings, Asthma control questionnaire, Quality of life questionnaire, Therapeutic agents


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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who can obtain informed consent to participate in research.

Key exclusion criteria

Women who are pregnant or may be pregnant.
Patients with other serious complication diseases.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hoshino
Middle name
Last name Makoto

Organization

Atami Hospital, International University of Health and Welfare

Division name

Division of Clinical Allergy

Zip code

413-0012

Address

13-1 Higashikaigan-cho, Atami, Shizuoka

TEL

0557-81-9171

Email

hoshino@iuhw.ac.jp


Public contact

Name of contact person

1st name Hoshino
Middle name
Last name Makoto

Organization

Atami Hospital, International University of Health and Welfare

Division name

Division of Clinical Allergy

Zip code

413-0012

Address

13-1 Higashikaigan-cho, Atami, Shizuoka

TEL

0557-81-9171

Homepage URL


Email

hoshino@iuhw.ac.jp


Sponsor or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Atami Hospital, International University of Health and Welfare

Address

13-1 Higashikaigan-cho, Atami, Shizuoka

Tel

0557-81-9171

Email

na-ayumi@iuhw.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

国際医療福祉大学熱海病院(静岡県)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 22 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

Open public recruiting

Date of protocol fixation

2020 Year 04 Month 27 Day

Date of IRB

2020 Year 06 Month 11 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2025 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2020 Year 06 Month 20 Day

Last modified on

2020 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046627


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name