House Dust Mite Rhinitis, Mite Allergy, Rhinitis, Allergic
Conditions
Keywords
Microneedle, Micro Array Patch, House Dust Mite Rhinitis
Brief summary
When administering clinical trial drugs to patients with house dust mite allergic rhinitis, safety/tolerance is comparatively evaluated as the primary outcome, and symptom improvement and immune activity of the disease are comparatively evaluated as secondary outcome.
Interventions
DRUGHouse Dust Mite Extract, Dermatophagoides Farinae
\[Group 1\] Group A receives 100 PAU at week 1 and 200 PAU at week 2 as the induction phase. 200 PAU is administered for 3 to 16 weeks as a maintenance phase. Group B (placebo group) is the placebo arm of group A. \[Group 2\] As the induction phase, group C received 100 PAU at week 1, 200 PAU at week 2, 300 PAU at week 3, and 400 PAU at week 4. As the maintenance phase, 400 PAU is administered for 5 to 16 weeks. Group D (placebo) is the placebo group in Group C. \[Group 3\] As the induction phase, group E received 100 PAU at week 1, 200 PAU at week 2, 300 PAU at week 3, 400 PAU at week 4, 600 PAU at week 5, and 800 PAU at week 6. As the maintenance phase, 800 PAU is administered from 7 to 16 weeks. Group F (placebo) is the placebo arm of group E.
Sponsors
RAPHAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 19 - 65years with allergic rhinitis caused by the house dust mite antigen. * ImmunoCAP® titer \> 3.49 kUA/L for the house dust mite antigen. * Determined to be suitable for clinical trials as a result of laboratory tests.
Exclusion criteria
* Patients with uncontrolled, severe, or moderate asthma according to the Global Initiative for Asthma (GINA) guidelines. * In case of lactation or pregnancy. * If an infectious disease that may affect this study is identified. * Patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug. * If the allergy skin prick test is negative for the house dust mite antigen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs | 1 day before dosing, Post-study visit(within 15 days after clinical completion) | Blood pressure (mmHg), Heart rate (BPM), Body temperature(℃) |
| Health examination | 1 day before dosing, Post-study visit(within 15 days after clinical completion) | \- Physical examination of necessary body parts by interviewing and observing the height (cm), weight (kg), auscultation (lung, heart), and other clinical test subjects |
| laboratory test | 1 day before dosing, Post-study visit(within 15 days after clinical completion) | Hematologic examination |
| Electrocardiography | 1 day before dosing, Post-study visit(within 15 days after clinical completion) | Measure the 12 lead electrocardiogram. All electrocardiograms are measured after the subject rests for at least 3 minutes in a supine position. |
| Local Adverse Event | 1 day before dosing, Post-study visit(within 15 days after clinical completion) | Local adverse events are removed from the subject 4 hours after attaching the clinical trial drug, and the attachment site is photographed and uploaded to the subject's diary (e-diary). The tester evaluates the presence of an adverse reaction through visual evaluation of the photo of the attachment site. |
| systemic adverse event | 1 day before dosing, Post-study visit(within 15 days after clinical completion) | Systemic adverse reaction evaluation was evaluated according to the WAO subcutaneous immunotherapy systemic reaction grading system. |
Countries
South Korea
Outcome results
None listed