UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008869
Receipt number 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 09:23:12

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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 or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



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

Value
https://center6.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