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Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis :
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCP1102 | Experimental |
| |
| HGP1408 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1102 | Drug | The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Mean Daytime Nasal Symptom Score | Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe). | base line, 3-4week(2weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Mean Nighttime Nasal Symptom Score | Nighttime nasal symptoms included nasal obstruction awakening (0 = none; 1 = mild; 2 = moderate; 3 = severe), difficulty getting to sleep (0 = not at all; 1 = little; 2 = moderate; 3 = severe), and nighttime awakening (0 = not at all; 1 = once; 2 = more than once; 3 = awake all night). | baseline, 3-4week(2weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Su Kim, M.D., Ph.D. | Gangnam Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital. | Seoul | 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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| HGP1408 | Drug | The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks. |
|
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |