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Observational study on the usefulness of telemedicine for patients initiating house dust mite sublingual immunotherapy

Not Applicable
Conditions
Perennial allergic rhinitis caused by house dust mite
Registration Number
JPRN-UMIN000053542
Lead Sponsor
Pauroom, Clinic for Children and Parents
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcome 1) Changes in responses on the usefulness of telemedicine during 48 weeks after the initiation of house dust mite sublingual immunotherapy
Secondary Outcome Measures
NameTimeMethod
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)
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