UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter observational study on "One airway, One disease" from the perspective of rhinosinusitis.
Acronym	"One airway, One disease" from the perspective of rhinosinusitis.
Scientific Title	A multicenter observational study on "One airway, One disease" from the perspective of rhinosinusitis.
Scientific Title:Acronym	"One airway, One disease" from the perspective of rhinosinusitis.
Region	Japan

Condition
Condition	Chronic rhinosinusitis Eosinophilic otitis media
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	(1) To investigate co-morbid lower respiratory tract diseases with both eosinophilic otitis media and each subclass of chronic rhinosinusitis. (2) To evaluate the effect of sinus surgery on asthmatic condition
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of co-morbid lower respiratory tract diseases with both eosinophilic otitis media and each subclass of chronic rhinosinusitis.
Key secondary outcomes	Evaluation of the effect of sinus surgery on asthmatic condition.

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	(1)Patients who had undergone the sinus surgery (ESS) (2)Patients with eosinophilic otitis media
Key exclusion criteria	None
Target sample size	180

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

Public contact
Name of contact person	1st name Middle name Last name Yasunori Sakuma
Organization	Yokohama City University Medical Center
Division name	Department of Otorhinolaryngology
Zip code
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	ysakuma@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,Respiratory Disease Center
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） 横浜市立大学附属病院(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 05 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 06 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 05 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	The evaluation of lower respiratory disease is performed by specialists in respiratory tract diseases. The evaluation for the effect of sinus surgery on asthmatic condition is a cohort study for one year after the surgery.

Management information
Registered date	2012 Year 09 Month 04 Day
Last modified on	2017 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010389

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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