UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007762
Receipt number R000009143
Scientific Title The mutual relationship between the symptoms of GERD, rhinosinusitis and asthma and the relation beteen the symptoms and airway inflammation in patients with asthma.
Date of disclosure of the study information 2012/04/16
Last modified on 2013/01/31 12:55:04

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Basic information

Public title

The mutual relationship between the symptoms of GERD, rhinosinusitis and asthma and the relation beteen the symptoms and airway inflammation in patients with asthma.

Acronym

The relation between the symptoms of GERD, rhinosisnusitis and asthma and the airway inflammation in patients with asthma

Scientific Title

The mutual relationship between the symptoms of GERD, rhinosinusitis and asthma and the relation beteen the symptoms and airway inflammation in patients with asthma.

Scientific Title:Acronym

The relation between the symptoms of GERD, rhinosisnusitis and asthma and the airway inflammation in patients with asthma

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Gastroenterology Pneumology Clinical immunology
Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the mutual relationship between the symptoms and the fractional concentration of exhaled nitric oxide in patients with asthma.

Basic objectives2

Others

Basic objectives -Others

Investigation on the biomarker of airway inflammation

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The significant correlation coefficient between the each symptom of asthma, GERD, rhinosinusitis, and the fractional concentration of exhaled nitric oxide

Key secondary outcomes



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

15 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with asthma

Key exclusion criteria

Subjects who do not have asthma

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tamotsu Ishizuka

Organization

Gunma University

Division name

Department of Medicine and Molecular Science

Zip code


Address

3-39-15 Showa-machi, Maebashi 371-8511, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Tamotsu Ishizuka

Organization

Gunma University

Division name

Department of Medicine and Molecular Science

Zip code


Address

3-39-25 Showa-machi Maebashi 371-8511, JAPAN

TEL


Homepage URL


Email



Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Gunma University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 16 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2012 Year 04 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

2012 Year 11 Month 30 Day

Date of closure to data entry

2012 Year 11 Month 30 Day

Date trial data considered complete

2012 Year 11 Month 30 Day

Date analysis concluded

2013 Year 03 Month 31 Day


Other

Other related information

We ask patients with asthma to answer two kinds of questionnaire on GERD, asthma, and rhinosisnusitis. At the same time, we measure the fractional concentration of exhaled nitric oxide in the patients. We will analyze the relations between each factor.


Management information

Registered date

2012 Year 04 Month 15 Day

Last modified on

2013 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009143


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name