UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039939 |
|---|---|
| Receipt number | R000045538 |
| Scientific Title | Efficacy and safety of house dust mite sublingual immunotherapy in preschool children with allergic rhinitis |
| Date of disclosure of the study information | 2020/03/25 |
| Last modified on | 2021/03/29 12:34:53 |
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Basic information
Public title
Efficacy and safety of house dust mite sublingual immunotherapy in preschool children with allergic rhinitis
Acronym
Efficacy and safety of house dust mite sublingual immunotherapy in preschool children with allergic rhinitis
Scientific Title
Efficacy and safety of house dust mite sublingual immunotherapy in preschool children with allergic rhinitis
Scientific Title:Acronym
Efficacy and safety of house dust mite sublingual immunotherapy in preschool children with allergic rhinitis
Region
| Japan |
Condition
Condition
Perennial allergic rhinitis
Classification by specialty
| Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of house dust mite sublingual immunotherapy for perennial allergic rhinitis in preschool children
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of nasal and eye symptom scores after a year
Key secondary outcomes
Improvement rate of Medication scores after a year
Frequency of adverse reaction
Change of parameters in blood
Sensitization of other inhaled antigens
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
| 1 | years-old | <= |
Age-upper limit
| 4 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patient with allergic rhinitis, who have specific IgE RAST score 1 for Dermatophagoides pteronyssinus.
2)Patient who have perennial allergic rhinitis symptoms.
Key exclusion criteria
1) Patients who have received immunotherapy.
2) Uncontrolled asthma patients.
3) Patients who were judged to be unsuitable for patient enrollment by their doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Ebisawa |
Organization
National Sagamihara Hospital
Division name
Department of Allergy, Clinical Research Center for Allergology and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa , Japan
TEL
042-742-8311
mebisawa@foodallergy.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Sasamoto |
Organization
National Sagamihara Hospital
Division name
Pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-742-8311
Homepage URL
kohki_sasamoto_0131@yahoo.co.jp
Sponsor or person
Institute
National Sagamihara Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Torii Pharmaceutical Co.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital
Address
18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
Tel
042-742-8311
222-rinri@mail.hosp.go.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
| 2020 | Year | 03 | Month | 25 | 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
38
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
| 2020 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 25 | 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
Changes in nasal symptoms by sublingual immunotherapy and investigation of adverse reactions by diary
Management information
Registered date
| 2020 | Year | 03 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045538
| 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 |
