UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056618 |
|---|---|
| Receipt number | R000064708 |
| Scientific Title | Cough Provocation by the mechanical stimulation of external ear cannals in asthmatic patients |
| Date of disclosure of the study information | 2025/01/15 |
| Last modified on | 2025/01/03 12:05:51 |
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Basic information
Public title
Cough Provocation by the mechanical stimulation of external ear cannals in asthmatic patients
Acronym
external ear cannal stimulation and cough provocation
Scientific Title
Cough Provocation by the mechanical stimulation of external ear cannals in asthmatic patients
Scientific Title:Acronym
external ear cannal stimulation and cough provocation
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the rate of cough provocation by mechanical stimulation of ear cannal (Arnold nerve cough reflex:ANCR).
Basic objectives2
Others
Basic objectives -Others
To evaluate the rate of cough accompanied by the itchy sensation of the ears and its relationship with ANCR.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of ANCR in asthma patients.
The rate of cough accompanied by itchy sensation of the ear cannals and its relationship with ANCR.
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 braonchial asthma and cough variant asthma who were treated in NHO Disaster Medical Center
Key exclusion criteria
The patients whom the appropriate medical history connot be evaluated.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Deaprtment of Pulmonology
Zip code
1900014
Address
Midoricho 3256, Tachikawa, Tokyo, Japan
TEL
0425265511
tdmckamimura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of Pulmonology
Zip code
1900014
Address
Midoricho 3256, Tachikawa, Tokyo, Japan
TEL
0425265511
Homepage URL
tdmckamimura@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Disaster Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Disaster Medical Center
Address
Midoricho 3256, Tachikawa, Tokyo, Japan
Tel
0425265511
tdmckamimura@yahoo.co.jp
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
| 2025 | Year | 01 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The rate of positive ANCR was 29.5%.
The rate of urge to cough, cough, asthma exacerbation accompanied by itchy sensation of ear cannal was 17.2% and significantly higher in ANCR positive group.
Management information
Registered date
| 2025 | Year | 01 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064708
