UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050533 |
|---|---|
| Receipt number | R000057545 |
| Scientific Title | A systematic review of the efficacy of macrolides for bronchial asthma in adults |
| Date of disclosure of the study information | 2023/03/08 |
| Last modified on | 2023/09/06 12:47:25 |
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Basic information
Public title
A systematic review of the efficacy of macrolides for bronchial asthma in adults
Acronym
Macrolides for bronchial asthma in adults
Scientific Title
A systematic review of the efficacy of macrolides for bronchial asthma in adults
Scientific Title:Acronym
Macrolides for bronchial asthma in adults
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of macrolides for bronchial asthma in adults
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exacerbation requiring hospitalization
Key secondary outcomes
Severe exacerbation
Symptom score
ACQ
AQLQ
SABA
FEV1
PEF
Serious adverse events including death
All adverse events
Airway hyperreactivity
Inflammation (peripheral blood eosinophils/sputum eosinophils)
OCS
serum/sputum ECP
FENO
Base
Study type
Others,meta-analysis etc
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with bronchial asthma
Key exclusion criteria
Not determined
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Ohnishi |
| Middle name | |
| Last name | Hiroshi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Respiratory Medicine and Allergology
Zip code
7838505
Address
Kohasu, Oko-Cho, Nankoku, Kochi, Japan
TEL
0888665811
honi@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Nagano |
| Middle name | |
| Last name | Tatsuya |
Organization
Kobe University Hospital
Division name
Respiratory Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825660
Homepage URL
tnagano@med.kobe-u.ac.jp
Sponsor or person
Institute
Japanese Society of Allergology
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Allergology
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
Japanese Society of Allergology
Address
1-13-3, Ueno, Taitou-ku, Tokyo
Tel
03-5807-1701
info@jsaweb.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 | 03 | Month | 08 | 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 | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Systematic review
Management information
Registered date
| 2023 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057545
