UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043535
Receipt number R000049579
Scientific Title Genetic analysis research in patients with asthma and chronic cough
Date of disclosure of the study information 2021/03/05
Last modified on 2021/03/05 20:46:20

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Basic information

Public title

Genetic analysis research in patients with asthma and chronic cough

Acronym

Genetic analysis research in patients with asthma and chronic cough

Scientific Title

Genetic analysis research in patients with asthma and chronic cough

Scientific Title:Acronym

Genetic analysis research in patients with asthma and chronic cough

Region

Japan


Condition

Condition

asthma and chronic cough

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To investigate genes related to pathophysiology and intractableness of asthma and chronic cough.

Basic objectives2

Others

Basic objectives -Others

To investigate genes related to small airway inflammation and capsaicin cough reflex sensitivity in patients with asthma and chronic cough.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To clarify associations between some genes and refractory asthma and chronic cough.

Key secondary outcomes



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

99 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with asthma and chronic cough aged 20 years and above, who have been seeing their doctors for at least 1 year.

Key exclusion criteria

Patients
with asthma and chronic cough aged 19 years and below
who continued to see their doctors for less than 1 year

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Fukumitsu
Middle name
Last name Kensuke

Organization

Nagoya City University

Division name

Department of Respiratory Medicine, Allergy and Clinical Immunology,

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Japan.

TEL

052-853-8216

Email

k-fkmt@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name Fukumitsu
Middle name
Last name Kensuke

Organization

Nagoya City University

Division name

Department of Respiratory Medicine, Allergy and Clinical Immunology,

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Japan.

TEL

052-853-8216

Homepage URL


Email

k-fkmt@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical research management center

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Japan.

Tel

052-858-7215

Email

clinical_research@med.nagoya-cu.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



Other administrative information

Date of disclosure of the study information

2021 Year 03 Month 05 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 07 Month 03 Day

Date of IRB

2020 Year 07 Month 14 Day

Anticipated trial start date

2021 Year 03 Month 05 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Genes will be analyzed in university of Shizuoka.
We are preparing that this study will be held in multicenter.


Management information

Registered date

2021 Year 03 Month 05 Day

Last modified on

2021 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049579


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name