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
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
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
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
