UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053542 |
|---|---|
| Receipt number | R000061054 |
| Scientific Title | Observational study on the usefulness of telemedicine for patients initiating house dust mite sublingual immunotherapy |
| Date of disclosure of the study information | 2024/02/06 |
| Last modified on | 2025/02/14 09:25:35 |
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Basic information
Public title
Observational study on the usefulness of telemedicine for patients initiating house dust mite sublingual immunotherapy
Acronym
Observational study on the usefulness of telemedicine for patients initiating house dust mite sublingual immunotherapy
Scientific Title
Observational study on the usefulness of telemedicine for patients initiating house dust mite sublingual immunotherapy
Scientific Title:Acronym
Observational study on the usefulness of telemedicine for patients initiating house dust mite sublingual immunotherapy
Region
| Japan |
Condition
Condition
Perennial allergic rhinitis caused by house dust mite
Classification by specialty
| Clinical immunology | Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of telemedicine for patients initiating house dust mite sublingual immunotherapy.
Basic objectives2
Others
Basic objectives -Others
An exploratory study of the usefulness of telemedicine
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome
1) Changes in responses to the questionnaire on the usefulness of telemedicine during 48 weeks after the initiation of house dust mite sublingual immunotherapy
Key secondary outcomes
Primary outcome
2) Proportion of patients who continued house dust mite sublingual immunotherapy at 48-week after the initiation of the therapy (Comparisons between the telemedicine and the face-to-face treatment groups)
Secondary outcome
1) Changes in proportion of patients who continued house dust mite sublingual immunotherapy during 48 weeks after the initiation of the therapy (Comparisons between the telemedicine and the face-to-face treatment groups)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Telemedicine group
1) Patients with perennial allergic rhinitis caused by house dust mite
2) Patients initiating house dust mite sublingual immunotherapy and hoping to be treated via telemedicine
3) Patients who have received face-to-face treatment prior to the date of consent, or are receiving such care at the time of consent
4) Patients who are able to receive telemedicine and complete the questionnaire using a device such as a smartphone, tablet, or personal computer. If a guardian, etc. gives consent as a legally acceptable representative, the guardian, etc. must respond to the questionnaire using a communication device such as a smartphone, tablet, or personal computer.
5) Patients who have been fully informed of the study and who have given their free and voluntary written consent based on a thorough understanding of the study. In the case of minors under 16 years old who have not completed the junior high school course or patients who are not judged to have sufficient capacity to make decisions regarding the conduct of the study, written consent by their legally acceptable representatives is also permitted.
Face-to-face treatment group
Data on patients who meet all of the following criteria will be extracted from the database (JMDC Claims Database).
1) Patients diagnosed with perennial allergic rhinitis caused by house dust mite before the index date
Key exclusion criteria
Telemedicine group
1) Patients who have received or are receiving house dust mite immunotherapy
2) Patients with a nasal disease (e.g., nasal polyps, deviated septum, hypertrophic rhinitis, etc.) to the extent that it interferes with the evaluation for effectiveness
3) Patients on anti-immunoglobulin E (IgE) antibody products, human anti-human interleukin (IL)-4/13 receptor monoclonal antibodies, or other antibody products indicated for allergic diseases
4) Patients with concomitant severe bronchial asthma (in adults) or severe persistent bronchial asthma (in children)
5) Patients who are lactating, pregnant, or hoping to become pregnant
6) Patients participating in other clinical researches or clinical trials involving interventions
7) Patients deemed unsuitable as research subjects by the principal investigator or sub-investigators
Face-to-face treatment group
Data on patients who do not violate any of the following criteria at the index date will be extracted from the database. However, exclusion criteria 1) is not applicable.
1) Patients with a history of telemedicine on the same day as the date of prescription of hyposensitization therapy drugs containing mite allergen extracts (allergen immunotherapy drugs) for house dust mite sublingual immunotherapy on or after the index date
2) Patients with a concomitant nasal disease (e.g., nasal polyps, deviated septum, hypertrophic rhinitis, etc.)
3) Patients on IgE antibody products, IL-4/13 receptor monoclonal antibodies, or other antibody products indicated for allergic diseases
4) Patients with concomitant severe bronchial asthma (in adults) or severe persistent bronchial asthma (in children)
5) Patients who are lactating, pregnant, or hoping to become pregnant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Haruo |
| Middle name | |
| Last name | Kuroki |
Organization
Pauroom, Clinic for Children and Parents
Division name
Clinic Director
Zip code
107-0061
Address
6F, Aoyama MY Building, 2-13-4 Kita-Aoyama, Minato-ku, Tokyo
TEL
03-6804-1892
clinic@pauroom.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yoden |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs Department
Zip code
541-0042
Address
2F, Nissay Yodoyabashi East, 3-13, Imabashi 3-Chome, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-2161
Homepage URL
takahiro.yoden@shionogi.co.jp
Sponsor or person
Institute
Pauroom, Clinic for Children and Parents
Institute
Department
Personal name
Haruo Kuroki
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takahashi Clinic Ethics Committee
Address
1F, Medical Hat, 5-1-31 Iwayakita-machi, Nada-ku, Kobe-shi, Hyogo 657-0846
Tel
078-882-6432
kishimoto.satoshi@neues.co.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
医療法人社団 嗣業の会 こどもとおとなのクリニック パウルーム（東京都）/ Pauroom, Clinic for Children and Parents(Tokyo)
一般社団法人 患者目線 患者目線のクリニック 虎ノ門 内科・皮膚科（東京都）/Patient First Clinic Toranomon(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multi-center,open-label, non-interventional, prospective, two-group comparative study with face-to-face treatment group as historical control to investigate the usefulness of telemedicine for patients with perennial allergic rhinitis who initiated house dust mite sublingual immunotherapy.
Management information
Registered date
| 2024 | Year | 02 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061054
