UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051534 |
|---|---|
| Receipt number | R000058797 |
| Scientific Title | Prevalence and clinical relevance of comorbid pertussis infection in adult patients with asthma |
| Date of disclosure of the study information | 2023/07/06 |
| Last modified on | 2023/07/06 01:05:07 |
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Basic information
Public title
Prevalence and clinical relevance of comorbid pertussis infection in adult patients with asthma
Acronym
Clinical relevance of pertussis infection in adult asthma
Scientific Title
Prevalence and clinical relevance of comorbid pertussis infection in adult patients with asthma
Scientific Title:Acronym
Clinical relevance of pertussis infection in adult asthma
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the prevalence and clinical relevance of pertussis infection in adult patients with asthma
Basic objectives2
Others
Basic objectives -Others
To compare the prevalence of newly diagnosed asthma, blood test results, pulmonary function test results, and questionnaire scores in adult patients with asthma and in those with non-asthmatic subacute/chronic cough
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the prevalence of pertussis infection
Key secondary outcomes
demographic characteristics of patients, the prevalence of newly diagnosed asthma, blood test results, pulmonary function test results, and questionnaire scores in adult patients with asthma and in those with non-asthmatic subacute/chronic cough
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
Newly referred, adult patients with asthma and with non-asthmatic subacute/chronic cough are enrolled.
Key exclusion criteria
Patients with abnormal chest X-ray findings or those without consent to the study are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Respiratory Medicine, Allergy and Clinical Immunology
Zip code
46708601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
+81528538216
tomokot@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Respiratory Medicine, Allergy and Clinical Immunology
Zip code
46708601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
+81528538216
Homepage URL
tomokot@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
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
Nagoya City University Certified Review Board
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
0528587215
rinshou-kenkyu@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
| 2023 | Year | 07 | Month | 06 | 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
121
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The prevalence of pertussis in newly referred patients with asthma and in those with non-asthmatic subacute/chronic cough is compared. Next, the prevalence of newly diagnosed asthma, demographic characteristics of patients, blood test results, pulmonary function test results, and questionnaire scores are compared between adult asthma with pertussis infection and those without.
Management information
Registered date
| 2023 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058797
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
