Perennial allergic rhinitis caused by house dust mite
Conditions
Interventions
None listed
Sponsors
Pauroom, Clinic for Children and Parents
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactTakahiro Yoden
Shionogi & Co., Ltd. Medical Affairs Department
Outcome results
None listed