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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 PAR. 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 6 weeks of treatment. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average of AM and PM patient-reported instantaneous TNSS over 6 weeks of treatment. | 6 weeks | |
| Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint. | 6 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 | Encinitas | California | 92924 | United States | ||
| Altana/Nycomed |
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| Label | URL |
|---|---|
| BY9010-M1-402-RDS-2005-04-05.pdf | View source |
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| Drug |
placebo |
|
| RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) at Endpoint |
| 6 weeks |
| Long Beach |
| California |
| 90806 |
| United States |
| Altana/Nycomed | Los Angeles | California | 90025 | United States |
| Altana/Nycomed | Mission Viejo | California | 92691 | United States |
| Altana/Nycomed | San Diego | California | 92123 | United States |
| Altana/Nycomed | San Jose | California | 95117 | United States |
| Altana/Nycomed | Colorado Springs | Colorado | 80907 | United States |
| Altana/Nycomed | Denver | Colorado | 80206 | United States |
| Altana/Nycomed | Denver | Colorado | 80230 | United States |
| Altana/Nycomed | Jupiter | Florida | 33458 | United States |
| Altana/Nycomed | Rockville | Maryland | 20850 | United States |
| Altana/Nycomed | North Dartmouth | Massachusetts | 02747 | United States |
| Altana/Nycomed | Minneapolis | Minnesota | 55402 | United States |
| Altana/Nycomed | St Louis | Missouri | 63141 | United States |
| Altana/Nycomed | Missoula | Montana | 59804 | United States |
| Altana/Nycomed | Brick | New Jersey | 08724 | United States |
| Altana/Nycomed | Skillman | New Jersey | 08558 | United States |
| Altana/Nycomed | Raleigh | North Carolina | 27607 | United States |
| Altana/Nycomed | Winston-Salem | North Carolina | 27103 | United States |
| Altana/Nycomed | Sylvania | Ohio | 43560 | United States |
| Altana/Nycomed | Fort Worth | Texas | 76132 | United States |
| Altana/Nycomed | Houston | Texas | 77084 | United States |
| Altana/Nycomed | Madison | Wisconsin | 53792-9988 | United States |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| 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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