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The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as a nasal spray once daily in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ciclesonide 200µg |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | 200µg Ciclesonide versus placebo |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Instantaneous patient-reported TNSS over the first two weeks of treatment | 4 weeks | |
| Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint | 4 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana/Nycomed | Austin | Texas | 78731 | United States | ||
| Altana/Nycomed |
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| Label | URL |
|---|---|
| BY9010-M1-401-RDS-2004-12-21.pdf | View source |
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| Drug |
placebo |
|
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at Endpoint |
| 4 weeks |
| Austin |
| Texas |
| 78759 |
| United States |
| Altana/Nycomed | Kerrville | Texas | 78028 | United States |
| Altana/Nycomed | New Braunfels | Texas | 78130 | United States |
| Altana/Nycomed | San Antonio | Texas | 78205 | United States |
| Altana/Nycomed | San Antonio | Texas | 78229 | United States |
| 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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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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