UMIN-ICDS Clinical Trial

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

Perennial allergic rhinitis caused by house dust mite

Classification by specialty

Clinical immunology	Pediatrics	Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Primary outcome
1) Changes in responses 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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

clinic@pauroom.jp

Name of contact person

1st name	Ken-ichi
Middle name
Last name	Setsukinai

Organization

Shionogi & Co., Ltd.

Division name

Medical Affairs Department

Zip code

541-0045

Address

1-8, Doshomachi 3-chome, Chuo-ku, Osaka

TEL

06-6202-2161

Homepage URL

Email

kenichi.setsukinai@shionogi.co.jp

Institute

Pauroom, Clinic for Children and Parents

Institute

Department

Personal name

Haruo Kuroki

Organization

Shionogi & Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Email

kishimoto.satoshi@neues.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

02

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public 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 related information

A single-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.

Registered date

2024

Year

02

Month

05

Day

Last modified on

2024

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061054