UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046907 |
|---|---|
| Receipt number | R000053481 |
| Scientific Title | Shizuoka Asthma Research Program |
| Date of disclosure of the study information | 2022/02/14 |
| Last modified on | 2024/04/10 13:15:14 |
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Basic information
Public title
Shizuoka Asthma Research Program
Acronym
SARP
Scientific Title
Shizuoka Asthma Research Program
Scientific Title:Acronym
SARP
Region
| Japan |
Condition
Condition
Severe Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A prospective multicenter study of patient background and clinical course in patients with severe asthma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of exacerbations after 1, 2, 3 years of registration
Key secondary outcomes
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) Patients diagnosed with bronchial asthma by a specialist.
(2) Patients who meet the definition of severe asthma
(3) Patients who regularly visit research institutes
(4) Patients over 20 years old
(5) Patients who can obtain the consent of voluntary participation in the examination in writing from the person or the substitute.
Key exclusion criteria
(1) Patients who can be later determined not to have severe asthma based on the course of treatment (when proper treatment such as vocal cord dysfunction, incorrect diagnosis of hysteria, poor adherence, etc.)
(2) Pulmonary function tests and questionnaires cannot be performed properly. Patients who were judged to be inappropriate for this study for other reasons.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Oishi |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, Japan
TEL
0534352263
Homepage URL
kyoishi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, Japan
Tel
0534352263
kyoishi@hama-med.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 | 02 | 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
159
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 | 11 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint;
Number of exacerbations in severe asthma
Number of exacerbations after 1, 2, 3 years of registration
Number of hospitalizations due to exacerbations 1, 2, 3 years after registration
Number of non-regular consultations due to exacerbation 1, 2 or 3 years after registration
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053481
