UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038285 |
|---|---|
| Receipt number | R000042158 |
| Scientific Title | Survey of refractory asthma complicated with bronchiectasis |
| Date of disclosure of the study information | 2019/10/21 |
| Last modified on | 2023/02/06 16:40:36 |
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Basic information
Public title
Survey of refractory asthma complicated with bronchiectasis
Acronym
Survey of refractory asthma complicated with bronchiectasis
Scientific Title
Survey of refractory asthma complicated with bronchiectasis
Scientific Title:Acronym
Survey of refractory asthma complicated with bronchiectasis
Region
| Japan |
Condition
Condition
refractory asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the number, treatment status and prognosis of refractory asthma complicated with bronchiectasis in Japan.
Basic objectives2
Others
Basic objectives -Others
Survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of refractory asthma cases with bronchiectasis
Key secondary outcomes
Change of control situation with change of treatment contents
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases treated at the Respiratory Society of Japan Accreditation / Related Facilities / Education Training Facility of Japan Allergy Society
Key exclusion criteria
Traction bronchiectasis by interstitial pneumonia
Target sample size
999
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54,Shogoinkawaharacho,Sakyo-ku,Kyoto-shi
TEL
075-751-3830
hmatsumo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Natsuko |
| Middle name | |
| Last name | Nomura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54,Shogoinkawaharacho,Sakyo-ku,Kyoto-shi
TEL
075-751-3830
Homepage URL
nnnomura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Japanese Respiratory Society,Novartis Pharmaceuticals Corporation
IRB Contact (For public release)
Organization
Medical Ethics Committee, Graduate School of Medicine, Kyoto University Hospital
Address
Department of Ethics Support, Kyoto University Hospital, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2019 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36539765/
Number of participants that the trial has enrolled
216
Results
In total, 216 cases from 81 facilities were reported. Infectious episodes were most frequent in the type 2-low group vs type 2-high and -intermediate groups. Among former type 2-high and -intermediate groups, 32% had recently transitioned to the -low group, to which relatively low FeNO in the past and oral corticosteroid use contributed.
Results date posted
| 2023 | Year | 02 | Month | 06 | Day |
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
Main results already published
Date of protocol fixation
| 2019 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
We will conduct a questionnaire survey about the number of the case, background, treatment, clinical history, blood test data, exhaled NO, Respiratory function test, sputum test, chest CT, and the difficult point of the diagnosis and/or control for the refractory asthma patients with bronchiodilation or bronchiolitis who visited to the hospital from 1/1/2015 to 9/30/2019
Management information
Registered date
| 2019 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042158
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
