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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008869
Receipt No. R000010409
Scientific Title The multicenter observational study on one airway, one disease through bronchial asthma.
Date of disclosure of the study information 2012/09/06
Last modified on 2017/09/13

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Basic information
Public title The multicenter observational study on one airway, one disease through bronchial asthma.
Acronym The multicenter observational study on one airway, one disease through bronchial asthma.
Scientific Title The multicenter observational study on one airway, one disease through bronchial asthma.
Scientific Title:Acronym The multicenter observational study on one airway, one disease through bronchial asthma.
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the proportion and the impact on clinical conditions of rhinosinusitis and tympanitisin in bronchial athma patients. Also to investigate the effects of treatments for chronic rhinosinusitis on asthma symptoms in bronchial asthma patients with chronic rhinosinusitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of rhinosinusitis and eosinophilic tympanitis diagnosised by an otolaryngologist in bronchial asthma patients.
Key secondary outcomes Clinical features of rhinosinusitis and eosinophilic tympanitis diagnosised by an otolaryngologist in bronchial asthma patients.
Interactions between upper and lower airway disease.
Effects of treatments for rhinosinusitis (rhinosinusitis surgery) on asthma symptoms.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria >=18-year-old
Documented agreement with full explanation of the study to the participant.
Patients with asthma diagnosed by pulmonologist.
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kaneko
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email takeshi@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaharu Shinkai
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email shinkai@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Yokohama City University Medical Center.Department of Otorhinolaryngology
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学付属病院(神奈川県)
藤沢市民病院(神奈川県)
横浜南共済病院(神奈川県))

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 06 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 Terminated
Date of protocol fixation
2012 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 06 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective, multi-center cross-sectional study based on chart information. Also, we conduct a prospective cohort study which follows for at least one year the patients who underwent rhinosinus surgery to determine its effect on bronchial asthma symptoms.

Management information
Registered date
2012 Year 09 Month 06 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010409

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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