UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019132 |
|---|---|
| Receipt number | R000022119 |
| Scientific Title | Effects of rush immunotherapy for Dermatophagoides |
| Date of disclosure of the study information | 2015/09/28 |
| Last modified on | 2022/04/03 09:56:24 |
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Basic information
Public title
Effects of rush immunotherapy for Dermatophagoides
Acronym
Effects of rush immunotherapy for Dermatophagoides
Scientific Title
Effects of rush immunotherapy for Dermatophagoides
Scientific Title:Acronym
Effects of rush immunotherapy for Dermatophagoides
Region
| Japan |
Condition
Condition
Allergic rhinitis, Bronchial asthma
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare the Effects of rush immunotherapy for Dermatophagoides between treatment group and control group
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL or Symptoms of allergic rhinitis or bronchial asthma (after one year)
Key secondary outcomes
QOL or Symptoms of allergic rhinitis or bronchial asthma (per visit)
Specific IgE, basophil activation test, specific IgG4, Forced Oscillation Technique, lung function, Fractional exhaled nitric oxide, and so on
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
blood test(pre, 1week, 1month, 3month, half-year, one-year, 10ml per time), bronchial challenge test(pre, one-year), spirometry(every visit, up to one-year), FeNO(every visit, up to one-year), Forced Oscillation Technique(every visit, up to one-year)
Interventions/Control_2
blood test(pre, one-year, 10ml per time), bronchial challenge test(pre, one-year), spirometry(every visit, up to one-year), FeNO(every visit, up to one-year), Forced Oscillation Technique(every visit, up to one-year)
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
| 5 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. >=5 years old, <18 years old
2. Positive with specific IgE of Dermatophagoides
3. Patient with allergic rhinitis or bronchial asthma(atopic)
4. No current other immunotherapy
5. In bronchial asthma: %FEV1.0>70, using ICS, not using omalizumab, mild intermittent asthma
Key exclusion criteria
no
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Asaumi |
Organization
Sagamihara National Hospital
Division name
Pediatrics
Zip code
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
042-742-8311
Ocean19oranges@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Asaumi |
Organization
Sagamihara National Hospital
Division name
Pediatrics
Zip code
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
042-742-8311
Homepage URL
Ocean19oranges@yahoo.co.jp
Sponsor or person
Institute
Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Consumer Affairs Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
相模原病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 28 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2015 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022119
| Research Plan | |
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| 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 |
