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This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic ciclesonide nasal spray compared with Omnaris™ nasal spray.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciclesonide Nasal Spray (Apotex, Inc.) | Experimental | Ciclesonide nasal spray
|
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| Omnaris™ nasal spray | Active Comparator | Omnaris™ Nasal Spray,
|
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| Placebo | Placebo Comparator | Placebo
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide nasal spray, 50 ÎĽg per actuation. | Drug | During placebo lead-in period: patients received placebo nasal spray, two actuations in each nostril once daily for 7 days. During treatment period: subjects were then assigned to one of the following three treatments according to the randomization scheme:
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Of Seasonal Allergic Rhinitis | Change from baseline in the combined reflective Total nasal symptom score (TNSS) (combined AM and PM reflective scores of runny nose, nasal congestion, nasal itchiness, and sneezing). | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Of Seasonal Allergic Rhinitis | Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing. | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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|
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| 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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