A clinical study to evaluate the efficacy and safety of tqc3564 tablets in the treatment of persistent allergic rhinitis. A total of 24 patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
TQC3564 tablets are CRTH2 antagonists.
The intervention drug is placebo.
The intervention drugs are TQC3564 tablets combined with montelukast sodium tablets. TQC3564 is a CRTH2 antagonist, montelukast sodium is Leukotriene receptor antagonist.
Xiangya Hospital Central South University
Changsha, Hunan, China
Total nasal symptom Score (TNSS)
Change in the investigator-assessed total nasal symptom score (TNSS) from baseline to 14 days. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms.
Time frame: Baseline, Day 14
Total ocular symptom score(TOSS)
Change in the TOSS from baseline to14 days. TOSS was the sum of 2 ocular symptoms with a minimum score of 0 units and amaximum score of 6 units, with higher score corresponding to increased ocular symptoms.
Time frame: Baseline, Day 14
Individual Total Nasal Symptom Score (TNSS)
Change in the individual TNSS from baseline to 14 days. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments.
Time frame: Baseline, Day 14
Individual Total Ocular Symptom Score (TOSS)
Change in the individual TOSS from baseline to 14 days. Individual ocular symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments.
Time frame: Baseline, Day 14
Daily symptoms score (dSS)
Change in the dSS from baseline to 14 days. dSS was the sum of 4 nasal symptoms and 2 ocular symptoms with a minimum score of 0 units and amaximum score of 18 units, with higher score corresponding to increased overall symptoms.
Time frame: Baseline, Day 14
Rescue medication proportion
Proportion of participants using rescue medication mometasone furoate nasal spray during intervention
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The intervention drugs are placebo combined with montelukast sodium tablets. Montelukast sodium is Leukotriene receptor antagonist.
Time frame: Day 1-32
Rescue medication frequency
Frequency of using rescue medication mometasone furoate nasal spray during intervention
Time frame: Day 1-32
Incidence of adverse events
Incidence of adverse events, including vital signs, physical examination, abnormal laboratory parameters, etc.,
Time frame: Day 1-32