UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022390 |
|---|---|
| Receipt number | R000025802 |
| Scientific Title | Efficacy of sublingual allergen immunotherapy in asthma with allergic rhinitis |
| Date of disclosure of the study information | 2016/05/20 |
| Last modified on | 2024/11/24 12:57:02 |
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Basic information
Public title
Efficacy of sublingual allergen immunotherapy in asthma with allergic rhinitis
Acronym
Efficacy of sublingual allergen immunotherapy in asthma
Scientific Title
Efficacy of sublingual allergen immunotherapy in asthma with allergic rhinitis
Scientific Title:Acronym
Efficacy of sublingual allergen immunotherapy in asthma
Region
| Japan |
Condition
Condition
Asthma with allergic rhinitis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of sublingual allergen immunotherapy in asthma with allergic rhinitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum periostin(after treatment at weeks 24,48,96,144)
Key secondary outcomes
Pulmonary function
FeNO
airway wall thckness
QoL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Allergen immunotherapy group (1 tablet/day over 3 year)
Interventions/Control_2
Control group
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Asthma with allergic rhinitis
Key exclusion criteria
1.Patients who have severe allergic reactions to this tablet.
2.Malignancy.
3.Strong severe ashma patients.
4.Pregnancy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hoshino |
Organization
Atami Hospital, International University of Health and Welfare
Division name
Division of Clinical Allergy
Zip code
413-0012
Address
13-1 Higashikaigan-cho, Atami, Shizuoka
TEL
0557-81-9171
hoshino@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Hoshino |
Organization
Atami Hospital, International University of Health and Welfare
Division name
Division of Clinical Allergy
Zip code
413-0012
Address
13-1 Higashikaigan-cho, Atami, Shizuoka
TEL
0557-81-9171
Homepage URL
hoshino@iuhw.ac.jp
Sponsor or person
Institute
Atami Hospital, International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Atami Hospital, International University of Health and Welfare
Address
13-1 Higashikaigan-cho, Atami
Tel
0557-81-9171
atami@iuhw.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
国際医療福祉大学熱海病院(静岡県)
Atami Hospital, International University of Health and Welfare
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025802
