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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
randomized, open-label, three arm, parallel group, multi-center study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciclesonide nasal spray | Experimental | ciclesonide nasal spray, alone |
|
| Levocetirizine | Active Comparator | Levocetirizine, alone |
|
| Ciclesonide nasal spray & Levocetirizine | Active Comparator | Ciclesonide nasal spray & Levocetirizine in combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | 200 ㎍ once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| rTNSS | change from baseline in the average of AM and PM patient assessed reflective TNSS | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| rTOSS | Reflective total ocular symptom sores | 2 weeks |
| TNSS | Patient assessed individual TNSS | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moonhwa Park, Doctor | Handok Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| handok pharmaceuticals co. LTD | Seoul | Seoul | 135-755 | South Korea |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
| C472067 | levocetirizine |
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| Levocetirizine | Drug | 5mg once daily |
|
|
| Ciclesonide & Levocetirizine | Drug |
|
|
|
| PANS | Physician-assessed overall nasal signs and symptoms severity (PANS) | 2 weeks |
| RQLQ | Rhinoconjunctivitis quality of life questionnaire (RQLQ) | 2 weeks |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |