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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
