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| ID | Type | Description | Link |
|---|---|---|---|
| SD-005-0703 |
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The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Nasal Spray |
|
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | 16mg Nasal Spray |
|
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| Measure | Description | Time Frame |
|---|---|---|
| To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers. | At 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment via adverse events and clinical measurements | At 1 & 2 weeks | |
| To assess efficacy of Rhinocort via the physician and caregivers assessments | At 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liza O'Dowd, MD | AstraZeneca | Study Director |
| Bertil Andersson | AstraZeneca | Study Director |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D000086722 | Rhinorrhea |
| D012912 | Sneezing |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Budesonide |
| Drug |
32mg Nasal Spray |
|
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| Budesonide | Drug | 64mg Nasal Spray |
|
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| Placebo | Drug |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |