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This study was closed per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC3564 tablets | Experimental | Orally administer TQC3564 tablets for 14 days. |
|
| placebo tablets | Placebo Comparator | Orally administer placebo tablets for 14 days. |
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| TQC3564 tablets + montelukast sodium tablets | Experimental | Orally administer TQC3546 tablets combined with Montelukast sodium tablets for 14 days. |
|
| placebo tablets + montelukast sodium tablets | Placebo Comparator | Orally administer placebo tablets combined with Montelukast sodium tablets for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC3564 tablets | Drug | TQC3564 tablets are CRTH2 antagonists. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 14 |
| Individual Total Nasal Symptom Score (TNSS) |
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Inclusion Criteria:
Age 18~65 years old, male or female;
Meet the clinical diagnostic criteria for allergic rhinitis, and the diagnosis is based on the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015, Tianjin)" issued by the Rhinology Group of the Otolaryngology Head and Neck Surgery Branch of the Chinese Medical Association:
Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 14 days before study enrollment , and must be non-lactating subjects; male subjects should agree to use contraception during the study period and for 6 months after the end of the study period.
The subjects voluntarily joined the study, signed the informed consent, and had good compliance.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
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| Placebo tablets |
| Drug |
The intervention drug is placebo. |
|
| TQC3564 tablets, montelukast sodium tablets | Drug | The intervention drugs are TQC3564 tablets combined with montelukast sodium tablets. TQC3564 is a CRTH2 antagonist, montelukast sodium is Leukotriene receptor antagonist. |
|
| Placebo tablets, montelukast sodium tablets | Drug | The intervention drugs are placebo combined with montelukast sodium tablets. Montelukast sodium is Leukotriene receptor antagonist. |
|
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. |
| 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. | 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. | Baseline, Day 14 |
| Rescue medication proportion | Proportion of participants using rescue medication mometasone furoate nasal spray during intervention | Day 1-32 |
| Rescue medication frequency | Frequency of using rescue medication mometasone furoate nasal spray during intervention | Day 1-32 |
| Incidence of adverse events | Incidence of adverse events, including vital signs, physical examination, abnormal laboratory parameters, etc., | Day 1-32 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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