UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000021486
Receipt No. 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 (Ver. 8)

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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024687