UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055192 |
|---|---|
| Receipt number | R000063059 |
| Scientific Title | The impact of cough receptor sensitivity and airway ciliary function on the onset and course of pulmonary nontuberculous mycobacteria. |
| Date of disclosure of the study information | 2024/08/07 |
| Last modified on | 2024/08/07 19:30:13 |
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Basic information
Public title
The impact of cough receptor sensitivity and airway ciliary function on the onset and course of pulmonary nontuberculous mycobacteria.
Acronym
The impact of cough receptor sensitivity and airway ciliary function on the onset and course of pulmonary nontuberculous mycobacteria.
Scientific Title
The impact of cough receptor sensitivity and airway ciliary function on the onset and course of pulmonary nontuberculous mycobacteria.
Scientific Title:Acronym
The impact of cough receptor sensitivity and airway ciliary function on the onset and course of pulmonary nontuberculous mycobacteria.
Region
| Japan |
Condition
Condition
Pulmonary nontuberculous mycobacteria
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of cough receptor sensitivity and airway ciliary function on the onset and course of pulmonary nontuberculous mycobacteria.
Basic objectives2
Others
Basic objectives -Others
To clarify the impact of cough receptor sensitivity and airway ciliary function on the onset and course of pulmonary nontuberculous mycobacteria.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capsaicin cough receptor sensitivity and airway ciliary beat frequency in patients with pulmonary nontuberculous mycobacteria.
Key secondary outcomes
Correlation between the capsaicin cough reflex sensitivity and the exacerbation of pulmonary nontuberculous mycobacteria.
Correlation between the airway ciliary beat frequency and the exacerbation of pulmonary nontuberculous mycobacteria.
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
1) subjects with aged 20 years or older
2) subjects with suspected or diagnosed pulmonary nontuberculous mycobacteria
Chest imaging findings are suspicious for pulmonary nontuberculous mycobacteria and are met by seeing one of the following
a) culture positive on at least one sputum specimen
b) culture positive on at least one bronchial lavage fluid
c) Transbronchial lung biopsy specimen shows histological findings consistent with mycobacterium infections.
d) positive for MAC antibodies
3) other pulmonary nontuberculous mycobacteria can be excluded
4) subjects who can get documentary consent by one's own free will after enough informed consent
Key exclusion criteria
1) subjects with pregnant, lactating or possibly pregnant
2) subjects with bronchial asthma or eosinophilic chronic rhinosinusitis
3) subjects taking gefapixant
4) subjects with a history of bronchial thermoplasty
5) others who judged inappropriate by other research researcher or research sharing doctor
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Johsuke |
| Middle name | |
| Last name | Hara |
Organization
Kanazawa University Hospital
Division name
Respiratory medicine
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa, Ishikawa
TEL
0762652000
hara0728@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Yamamura |
Organization
Kanazawa University Hospital
Division name
Respiratory medicine
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa, Ishikawa
TEL
0762652000
Homepage URL
kenta-yamamura@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
Kanazawa University
Address
13-1, Takara-machi, Kanazawa, Ishikawa
Tel
0762652000
kenta-yamamura@staff.kanazawa-u.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
| 2024 | Year | 08 | Month | 07 | 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
| 2024 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 07 | 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
Obserbational study of pulmonary nontuberculous mycobacteria
Management information
Registered date
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063059
