UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061725 |
|---|---|
| Receipt number | R000070645 |
| Scientific Title | A prospective observational study evaluating changes in oral and nasal exhaled nitric oxide (NO) before and after epipharyngeal abrasive therapy (EAT) in patients with chronic nasopharyngitis |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/28 21:32:06 |
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Basic information
Public title
A study to evaluate changes in exhaled nitric oxide (NO) before and after treatment in patients with chronic nasopharyngitis
Acronym
EAT-NO Study
Scientific Title
A prospective observational study evaluating changes in oral and nasal exhaled nitric oxide (NO) before and after epipharyngeal abrasive therapy (EAT) in patients with chronic nasopharyngitis
Scientific Title:Acronym
EAT-NO Study
Region
| Japan |
Condition
Condition
Chronic nasopharyngitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to prospectively evaluate changes in oral and nasal exhaled nitric oxide (NO) before and after epipharyngeal abrasive therapy (EAT) in patients with chronic nasopharyngitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in oral exhaled nitric oxide (NO) before and after epipharyngeal abrasive therapy (EAT) in patients with chronic nasopharyngitis (difference between baseline and after 12 sessions of EAT)
Key secondary outcomes
Changes in nasal exhaled nitric oxide (NO) before and after epipharyngeal abrasive therapy (EAT)
Association between changes in oral and nasal exhaled nitric oxide (NO) and clinical parameters (endoscopic findings score and symptom visual analog scale [VAS])
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with chronic nasopharyngitis
Age 15 years or older
Patients initiating epipharyngeal abrasive therapy (EAT)
Written informed consent obtained
Key exclusion criteria
Patients with acute upper respiratory infection
Patients with acute exacerbation of asthma
Patients unable to perform exhaled NO measurement
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Mogitate |
Organization
Mogitate ENT Clinic
Division name
Mogitate ENT Clinic
Zip code
2130011
Address
4F-401, Sekiguchi Daiichi Building, 1-2-5 Hisamoto, Takatsu-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0448654187
mogitateentjp@m08.itscom.net
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Mogitate |
Organization
Mogitate Medical Corporation
Division name
Mogitate ENT Clinic
Zip code
2130011
Address
4F-401, Sekiguchi Daiichi Building, 1-2-5 Hisamoto, Takatsu-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0448654187
Homepage URL
mogitateentjp@m08.itscom.net
Sponsor or person
Institute
Medical Corporation Mogitate (Mogitate ENT Clinic)
Institute
Department
Personal name
Manabu Mogitate
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board: Ota General Hospital Ethics Committee
Address
1-50 Nisshin-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
Tel
0442440131
info@ota-g-hospital.com
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
| 2026 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No additional information
Management information
Registered date
| 2026 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070645
