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The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Budesonide |
|
| 2 | Active Comparator | Fluticasone propionate |
|
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug |
|
| |
| Fluticasone propionate |
| Measure | Description | Time Frame |
|---|---|---|
| To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. | 2 weeks | |
| To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. |
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Inclusion Criteria:
At least a 2 year documented history of seasonal allergic rhinitis
who, in the opinion of the investigator,
is a candidate for treatment with nasal steroids based on a history of either
A positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael E Ruff, MD | Pharmaceutical Research, Dallas, USA | Principal Investigator |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D000086722 | Rhinorrhea |
| D012912 | Sneezing |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
|
|
| Placebo | Drug |
|
| 2 weeks |
| Safety assessment via adverse events and clinical measurements. | 2 & 4 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| 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 |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |