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| ID | Type | Description | Link |
|---|---|---|---|
| D5360C00698 |
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The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Rhinocort |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide | Drug | Current product |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing) | 2 weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Durability of device | End of study | |
| Safety assessment via adverse events and clinical measurements | 2 weekly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaile Shah, MD | Allergy & Asthma Consultant, NJ, USA. | Principal Investigator |
| Bertil Andersson | AstraZeneca | Study Director |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| 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 |
| Device |
New type device |
|
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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 |