UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058427 |
|---|---|
| Receipt number | R000066803 |
| Scientific Title | Assessment of Voluntary Cough and Involuntary Cough Evoked by Citric Acid Inhalation |
| Date of disclosure of the study information | 2025/07/10 |
| Last modified on | 2025/07/10 22:55:07 |
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Basic information
Public title
Assessment of Voluntary Cough and Involuntary Cough Evoked by Citric Acid Inhalation
Acronym
Cough Evaluation Study
Scientific Title
Assessment of Voluntary Cough and Involuntary Cough Evoked by Citric Acid Inhalation
Scientific Title:Acronym
Cough Evaluation Study
Region
| Japan |
Condition
Condition
Respiratory diseases (e.g., pneumonia), laryngeal and pharyngeal diseases (e.g., vocal cord paralysis), impaired consciousness, tracheostomy tube placement and healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We devised a method to measure cough peak flow (CPF) through the oropharynx using a peak flow meter during involuntary cough (cough reflex) induced by nasal administration of citric acid via a mesh nebulizer, and aimed to evaluate its utility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CPF during Involuntary and Voluntary Cough
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged 20 years or older who provided written informed consent to participate in the study based on sufficient explanation and understanding, and of their own free will or that of their family.
Key exclusion criteria
Patients with severe uncontrolled asthma
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukakecho,Toyoake, Aichi
TEL
0562-93-2167
otaka119@mac.com
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Matsuura |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
454-8509
Address
1-98 Dengakugakubo, Kutsukakecho,Toyoake, Aichi
TEL
052-323-5628
Homepage URL
hero850411@yahoo.co.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192
Tel
+81-562-93-2865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HM24-495
Org. issuing International ID_1
Fujita Health University Medical Research Ethics Committee
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 | 07 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The authors declare no conflicts of interest related to this study.
Management information
Registered date
| 2025 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066803
