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The primary objective of this study is to demonstrate the efficacy of ciclesonide HFA, applied as a nasal aerosol 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 HFA 75 mcg (37,5 mcg / actuation, 1 actuation/nostril), once daily |
|
| 2 | Active Comparator | Ciclesonide HFA 150 mcg (75 mcg / actuation, 1 actuation/nostril), once daily |
|
| 3 | Active Comparator | Ciclesonide HFA 300 mcg (150 mcg / actuation, 1 actuation/nostril), once daily |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide HFA | Drug | 75 mcg Ciclesonide HFA versus Placebo |
| |
| Ciclesonide HFA |
| Measure | Description | Time Frame |
|---|---|---|
| Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average of AM and PM patient-reported instantaneous TNSS over the first two weeks of treatment | 2 weeks | |
| Physician-assessed total nasal symptoms score (PNSS) over the treatment period | 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 | Mission Viejo | California | 92691 | United States | ||
| Altana/Nycomed |
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| Drug |
150 mcg Ciclesonide HFA versus Placebo |
|
| Ciclesonide HFA | Drug | 300 mcg Ciclesonide HFA versus Placebo |
|
| Placebo | Drug | Placebo |
|
| Rhinoconjunctivitis Quality of Life Questionaire (RQLQ) over the treatment period in patients (adolescents and adults) with impaired quality of life at Baseline defined as a RQLQ score of greater than 3.0 |
| 4 weeks |
| Orange |
| California |
| 92868 |
| United States |
| Altana/Nycomed | San Diego | California | 92123 | United States |
| Altana/Nycomed | Colorado Springs | Colorado | 80907 | United States |
| Altana/Nycomed | Denver | Colorado | 80230 | United States |
| Altana/Nycomed | Gainsville | Georgia | 30501 | United States |
| Altana/Nycomed | Savannah | Georgia | 31406 | United States |
| Altana/Nycomed | Stockbridge | Georgia | 30281 | United States |
| Altana/Nycomed | Indianapolis | Indiana | 46208 | United States |
| Altana/Nycomed | Overland Park | Kansas | 66210 | United States |
| Altana/Nycomed | Bethesda | Maryland | 20814 | United States |
| Altana/Nycomed | Minneapolis | Minnesota | 55402 | United States |
| Altana/Nycomed | St Louis | Missouri | 63141 | United States |
| Altana/Nycomed | Lincoln | Nebraska | 68505 | United States |
| Altana/Nycomed | Papillion | Nebraska | 68046 | United States |
| Altana/Nycomed | Skillman | New Jersey | 08558 | United States |
| Altana/Nycomed | West Brick | New Jersey | 08724 | United States |
| Altana/Nycomed | Raleigh | North Carolina | 27607 | United States |
| Altana/Nycomed | Ashland | Oregon | 97520 | United States |
| Altana/Nycomed | Medford | Oregon | 97504 | United States |
| Altana/Nycomed | Portland | Oregon | 97213 | United States |
| Altana/Nycomed | Blue Bell | Pennsylvania | 19422 | United States |
| Altana/Nycomed | Pittsburgh | Pennsylvania | 15241 | United States |
| Altana/Nycomed | Upland | Pennsylvania | 19013 | United States |
| Altana/Nycomed | Charleston | South Carolina | 29414 | United States |
| Altana/Nycomed | Austin | Texas | 78750 | United States |
| Altana/Nycomed | New Braunfels | Texas | 78130 | United States |
| Altana/Nycomed | San Antonio | Texas | 78229 | United States |
| Altana/Nycomed | Draper | Utah | 84020 | United States |
| Altana/Nycomed | Burke | Virginia | 22015 | United States |
| Altana/Nycomed | Richmond | Virginia | 23226 | 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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