UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058428 |
|---|---|
| Receipt number | R000066806 |
| Scientific Title | Additive effect of P2X3 inhibitor, gefapixant, on azelastin for refractory atopic cough |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/07/11 00:23:36 |
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Basic information
Public title
Additive effect of P2X3 inhibitor, gefapixant, on azelastin for refractory atopic cough
Acronym
Additive effect of P2X3 inhibition for refractory atopic cough
Scientific Title
Additive effect of P2X3 inhibitor, gefapixant, on azelastin for refractory atopic cough
Scientific Title:Acronym
Additive effect of P2X3 inhibition for refractory atopic cough
Region
| Japan |
Condition
Condition
Atopic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A retrospective clinical study will be conducted to evaluate the efficacy of gefapixant, a P2X3 inhibitor for the new treatment of chronic cough, in patients with refractory atopic cough in real clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cough sensitivity for capsaicin inhalation
Key secondary outcomes
visual analog score of cough
The Leicester Cough Questionnaire (LCQ)
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Refractory atopic cough
Key exclusion criteria
(1) Patients with unstable comorbidities
(2) Other patients deemed inappropriate as research subjects by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YOSHIHISA |
| Middle name | |
| Last name | ISHIURA |
Organization
Medical Center of Kansai Medical University
Division name
Respiratory and Allergy Medicine, Kansai Medial University
Zip code
5708507
Address
Fumizono-machi 10-15,Moriguchi
TEL
09089686294
ishiuray@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | YOSHIHISA |
| Middle name | |
| Last name | ISHIURA |
Organization
Kansai Medial University
Division name
Respiratory and Allergy Medicine,
Zip code
5708507
Address
10-15 Fumizono-cho, Moriguchi, Osaka, 570-8507, Japan.
TEL
09089686294
Homepage URL
ishiuray@takii.kmu.ac.jp
Sponsor or person
Institute
Respiratory and Allergy Medicine, Kansai Medial University
Institute
Department
Personal name
YOSHIHISA ISHIURA
Funding Source
Organization
Kansai Medical University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Center, Kansai Medical Center
Address
10-15 Fumizono-cho, Moriguchi, Osaka, 570-8507, Japan.
Tel
09089686294
ishiuray@takii.kmu.ac.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
大阪府
Institutions
Institutions
関西医科大学 内科学第一講座 呼吸器アレルギー内科
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 30 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2025 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066806
