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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038285
Receipt No. R000042158
Scientific Title Survey of refractory asthma complicated with bronchiectasis
Date of disclosure of the study information 2019/10/21
Last modified on 2019/10/13

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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
Email 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
Email nnnomura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 30 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
2019 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.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


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