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4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial
4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial to Evaluate the Efficacy and Safety of HL151 versus Placebo in perennial allergic rhinitis patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment |
|
| Placebo Comparator | Placebo Comparator | HL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL151 | Drug | HL151(1Tab) once a day for 4 weeks of treatments |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in total rTNSS(Reflective TNSS) score | Changes in total rTNSS(Reflective TNSS) score at 4 weeks after clinical drug administration compared to baseline | Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in rTNSS(Reflective TNSS) score | Changes in rTNSS(Reflective TNSS) score at 2 weeks after clinical drug administration compared to baseline | Visit 2 (0 week), Visit 3 (2 weeks) |
| Changes in iTNSS(Instananeous TNSS) score |
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Inclusion Criteria:
Exclusion Criteria:
Patients with non-allergic rhinitis
Patients with asthma due to the following diseases(but patients with mild and intermittent asthma are available to participate in clinical trials)
Patients with obstructive nasal polyp or severe deviated nasal septum
Patients who Within 12 weeks from the date of screening, had damage or surgery around nasal cavity
Patients with anamnesis in acute /chronic sinusitis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Gyeonggi-do | 13620 | South Korea |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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Double-blinded
| placebo |
| Drug |
HL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments |
|
Changes in iTNSS(Instananeous TNSS) score at 2 weeks and 4 weeks after clinical drug administration compared to baseline
| Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks) |
| Changes in rTNSS(Reflective TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy) | Changes in rTNSS(Reflective TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy) at 2 weeks and 4 weeks after clinical drug administration compared to baseline | Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks) |
| Changes in iTNSS(Instananeous TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy) | Changes in iTNSS(Instananeous TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy) at 2 weeks and 4 weeks after clinical drug administration compared to baseline | Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks) |
| Investigator's assessment of overall treatment | Investigator's assessment of overall treatment | Visit 4 (4 weeks) |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |