UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040214 |
|---|---|
| Receipt number | R000045867 |
| Scientific Title | Long-term change in capsaicin cough reflex sensitivity with asthma treatments |
| Date of disclosure of the study information | 2020/04/21 |
| Last modified on | 2021/03/26 09:15:43 |
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Basic information
Public title
Long-term change in capsaicin cough reflex sensitivity with asthma treatments
Acronym
Long-term change in capsaicin cough reflex sensitivity with asthma treatments
Scientific Title
Long-term change in capsaicin cough reflex sensitivity with asthma treatments
Scientific Title:Acronym
Long-term change in capsaicin cough reflex sensitivity with asthma treatments
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association of long-term change in capsaicin cough reflex sensitivity with treatment intervention in patients with asthma.
Basic objectives2
Others
Basic objectives -Others
To evaluate the association of the change in capsaisin cough reflex sensitivity with asthma control and severity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate long-term change in capsaicin cough reflex sensitiviy (1 to 5 years) with asthma treatment in the stratification with severe and non-severe asthma.
Key secondary outcomes
To determine the improvement of capsaicin cough sensitivity by biologic agents.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
asthma and cough-variant asthma
Key exclusion criteria
Those who have other respiratory disease
Those who are pregnant
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1 kawasumi, mizuho-cho, mizuho-ku,Nagoya
TEL
0528538216
kaney32@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Fukumitsu |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1 kawasumi, mizuho-cho, mizuho-ku,Nagoya
TEL
0528538216
Homepage URL
k-fkmt@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology of the Japanese government
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
Nagoya City University Clinical research center
Address
1 kawasumi, mizuho-cho, mizuho-ku,Nagoya
Tel
0538537215
clinical_research@med.nagoya-cu.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 21 | 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
| 2020 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the association of long-term change in capsaicin cough reflex sensitivity with asthma control and severity in patients with asthma.
Management information
Registered date
| 2020 | Year | 04 | Month | 21 | Day |
Last modified on
| 2021 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045867
