UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The multicenter observational study on one airway, one disease through bronchial asthma.
Title of the study (Brief title)	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	Takeshi Kaneko
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
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	Masaharu Shinkai
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 07 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010409