UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058788 |
|---|---|
| Receipt number | R000067219 |
| Scientific Title | The effect of respiratory viral infection on exacerbation of bronchiectasis: a prospective cohort study |
| Date of disclosure of the study information | 2025/08/14 |
| Last modified on | 2025/08/13 14:10:39 |
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Basic information
Public title
The effect of respiratory viral infection on exacerbation of bronchiectasis: a prospective cohort study
Acronym
The effect of respiratory viral infection on exacerbation of bronchiectasis: a prospective cohort study
Scientific Title
The effect of respiratory viral infection on exacerbation of bronchiectasis: a prospective cohort study
Scientific Title:Acronym
The effect of respiratory viral infection on exacerbation of bronchiectasis: a prospective cohort study
Region
| Japan |
Condition
Condition
Bronchiectasis and respiratory viral infections
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this prospective cohort study of patients with bronchiectasis is to clarify the detection status of respiratory viruses during stable and exacerbation periods and their impact on clinical outcomes.
Basic objectives2
Others
Basic objectives -Others
The objective of this prospective cohort study of patients with bronchiectasis is to clarify the detection status of respiratory viruses during stable and exacerbation periods and their impact on clinical outcomes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint will be calculated as the odds ratio of respiratory virus detection rates by type during exacerbations and during stable periods.
Key secondary outcomes
In the secondary endpoints, we will compare the clinical characteristics of viral positive exacerbations and negative exacerbations (temporal changes in inflammatory markers, respiratory function, and quality of life scores [Quality of Life-Bronchiectasis; QOL-B], exacerbation frequency according to the severity of bronchiectasis [Bronchiectasis Severity Index; BSI], and frequency of severe exacerbations). Additionally, we will perform similar analyses for each viral strain.
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
Patients with bronchiectasis who are 18 years of age or older, have had no exacerbations in the past 4 weeks, and have provided informed consent to participate in this study are eligible for inclusion. The diagnosis of bronchiectasis is based on chest HRCT findings of bronchiectasis and the presence of two of the following clinical symptoms: cough, sputum production, or a history of exacerbations.
Key exclusion criteria
Patients with cystic fibrosis, active tuberculosis, AIDS, those currently taking immunosuppressive drugs, those currently receiving systemic steroid therapy (equivalent to 20 mg/day or more of prednisolone on a daily basis), malignant tumors, or pulmonary fibrosis (traction bronchiectasis) are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Sada |
Organization
Kyorin University Hospital
Division name
Department of Respiratory Medicine
Zip code
181-8611
Address
6-20-2 shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL
+81-422-47-5511
rainbow_orch@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Shirai |
Organization
Japan Institute for Health Security
Division name
Department of Respiratory Viruses
Zip code
208-0011
Address
4-7-1 Gakuen, Musashimurayama, Tokyo 208-0011, Japan
TEL
+81-42-561-0771
Homepage URL
shirai@niid.go.jp
Sponsor or person
Institute
Kyorin University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Institute for Health Security
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University
Address
6-20-2 shinkawa, Mitaka, Tokyo 181-8611, Japan
Tel
+81-422-47-5511
rec@ks.kyorin-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
| 2025 | Year | 08 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2025 | Year | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067219
