UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049011 |
|---|---|
| Receipt number | R000055839 |
| Scientific Title | REsearch for Asthma and COPD exacerbaTION induced by SARS-CoV2 vaccination (REACTION Study) |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2022/10/25 16:53:27 |
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Basic information
Public title
REsearch for Asthma and COPD exacerbaTION induced by SARS-CoV2 vaccination (REACTION Study)
Acronym
REsearch for Asthma and COPD exacerbaTION induced by SARS-CoV2 vaccination (REACTION Study)
Scientific Title
REsearch for Asthma and COPD exacerbaTION induced by SARS-CoV2 vaccination (REACTION Study)
Scientific Title:Acronym
REsearch for Asthma and COPD exacerbaTION induced by SARS-CoV2 vaccination (REACTION Study)
Region
| Japan |
Condition
Condition
Bronchial asthma, COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Both asthma and COPD are known to be exacerbated by viral or bacterial infections, and COPD and severe asthma are actually known risk factors for aggravation of COVID-19.Therefore, these patients would benefit greatly from COVID-19 vaccination. On the other hand, we also experience cases of developing asthma or exacerbation of asthma triggered by COVID-19 vaccination in our daily practice. This suggests that some immunological mechanism associated with COVID-19 vaccination is involved in the exacerbation of asthma and COPD.
The purpose of this research is to identify the clinical factors and phenotypes of asthma and COPD in patients who are prone to exacerbation of asthma and COPD as a result of COVID-19 vaccination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To elucidate the background factors and asthma/COPD phenotypes of patients who are prone to exacerbation of asthma/COPD triggered by COVID-19 vaccination.
Key secondary outcomes
1. Identify biomarkers associated with exacerbation of asthma and COPD by COVID-19 vaccination.
2. To assess whether COVID-19 vaccination is a risk factor for exacerbation of asthma/COPD.
3. To examine the feasibility of COVID-19 revaccination by examining the outcome of exacerbated cases with COVID-19 vaccination
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
1.Patients who are visiting or are visiting for the first time at the Outpatient Department of Asthma and Chronic Cough at Nagoya City University or the Outpatient Department of Respiratory Medicine at the above joint research institute hospital.
2 Patients with asthma or COPD.
3 Patients who have received at least 1 dose of COVID-19 vaccine from December 2021.
4 Patients who have given written informed consent to participate in this study
Key exclusion criteria
1 Patients with other obvious respiratory diseases such as lung cancer, interstitial lung disease (excluding bronchiectasis).
2 Patients who are judged to be unsuitable as subjects by the investigator (co-investigator).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University Hospital
Division name
Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-shi
TEL
0528515511
kaney32@outlook.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University Hospital
Division name
Clinical Research Development Support Center
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-shi
TEL
0528587215
Homepage URL
kaney32@outlook.com
Sponsor or person
Institute
Nagoya City University Hospital
Allergy and Clinical Immunology
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toyokawa City Hospital, Asahi Rosai Hospital, Shizuoka Prefectural General Hospital, Teikyo University Hospital, Meijo Hospital, Kyoto Katsura Hospital, Gunma University Hospital, Toshiwakai Medical Center Le Clinic, Kasai Yokoyama Internal Medicine/Respiratory Medicine Clinic, Gamagori City Hospital, Keio University Hospital,Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Clinical Trials Management Center
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-shi
Tel
0528538078
inui-mizuyo@sec.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
| 2022 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
https://www.umin.ac.jp/ctr/index-j.htm
Management information
Registered date
| 2022 | Year | 09 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055839
| 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 |
