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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
\[Group 1\] 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.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Vital signs
Blood pressure (mmHg), Heart rate (BPM), Body temperature(℃)
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Health examination
\- Physical examination of necessary body parts by interviewing and observing the height (cm), weight (kg), auscultation (lung, heart), and other clinical test subjects
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Hematologic examination
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Blood coagulation test
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Blood chemistry test
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Electrocardiography
Measure the 12 lead electrocardiogram. All electrocardiograms are measured after the subject rests for at least 3 minutes in a supine position.
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Local Adverse Event
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.
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
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systemic adverse event
Systemic adverse reaction evaluation was evaluated according to the WAO subcutaneous immunotherapy systemic reaction grading system.
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)