UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021486
Receipt number R000024687
Scientific Title The contributing factors to the responsiveness of inhaled corticosteroids in patients with untreated asthma
Date of disclosure of the study information 2016/03/17
Last modified on 2020/05/06 19:21:40

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Basic information

Public title

The contributing factors to the responsiveness of inhaled corticosteroids in patients with untreated asthma

Acronym

The contributing factors to the responsiveness of inhaled corticosteroids in patients with untreated asthma

Scientific Title

The contributing factors to the responsiveness of inhaled corticosteroids in patients with untreated asthma

Scientific Title:Acronym

The contributing factors to the responsiveness of inhaled corticosteroids in patients with untreated asthma

Region

Japan


Condition

Condition

asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify some contributing factors to the responsiveness of inhaled corticosteroids in patients with untreated asthma

Basic objectives2

Others

Basic objectives -Others

To identify some contributing factors to the responsiveness of inhaled corticosteroids in patients with untreated asthma

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To identify some contributing factors to the amount of changes of forced expiratory volume in 1 second (FEV1) or FEV1 predicted normal (%FEV1)

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

Patient with asthma who have not received inhaled cotrticosteroids at the time of diagnosis, and taken pulmonary function test at about 6 months and 1 year after diagnosis.

Key exclusion criteria

If patients meet the following criteria, they are excluded.

Patients who

have already received inhaled corticosteroids.

have restrictive lung diseases such as intestitial lung disease or diffuse pleural thickening.

have severe bronchiectasis.

have primary lung cancer, metastatic lung cancer, or pulmonary invasion of hematologic tumor

have surgical history of lung including partial resection

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Kanemitsu

Organization

Nagoya City University

Division name

Dept of Respiratory Medicine, Allergy and Clinical Immunology

Zip code

4678601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-853-8216

Email

kaney32@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name Kensuke
Middle name
Last name Fukumitsu

Organization

Nagoya City University

Division name

Dept of Respiratory Medicine, Allergy and Clinical Immunology

Zip code

4678601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-853-8216

Homepage URL


Email

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


Sponsor or person

Institute

Nagoya City University Dept of Respiratory Medicine, Allergy and Clinical Immunology

Institute

Department

Personal name



Funding Source

Organization

Nagoya City University Dept of Respiratory Medicine, Allergy and Clinical Immunology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Daidou hospital and daidou clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical research management center, Nagoya City University Hospital

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

Tel

052-851-5511

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

名古屋市立大学病院(愛知県)、大同病院・だいどうクリニック(愛知県)


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 17 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

13

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

We could not analyze because of small samples. We have already submitted a new research plan using optout to institutional review board of our university.

Date of the first journal publication of results


Baseline Characteristics

Patients who were diagnosed asthma first time and did not receive treatments for asthma at the diagnosis.

Participant flow

Patients who were steroid-naive asthma at the first visit and took pulmonary function test at 6 and 12 months after treatments intervention were enrolled.

Adverse events

Nothing.

Outcome measures

Factors contributing to changes in pulmonary function.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 02 Month 25 Day

Date of IRB

2016 Year 01 Month 19 Day

Anticipated trial start date

2016 Year 03 Month 17 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Design
retrospective study

Enrollment
Patients who met the criteria of this study will be enrolled between March 2016 and March 2018.


Management information

Registered date

2016 Year 03 Month 15 Day

Last modified on

2020 Year 05 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024687


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name