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The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose administration and six consecutive days of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine Nasal Spray (Patanase) | Active Comparator |
| |
| Fluticasone Furoate Nasal Spray (Veramyst) | Active Comparator |
| |
| Saline Nasal Spray (Placebo) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Furoate Nasal Spray | Drug | Fluticasone Furoate Nasal Spray: 110mcg QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Signs and Symptoms (TNSS) | TNSS (0-12 unit scale) is defined as the sum of the four nasal symptom scores recorded for nasal itching, sneezing, rhinorrhea and nasal congestion. | Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Expiratory Flow Rate (PEFR) | Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure | |
| Peak Nasal Inspiratory Flow (PNIF) | Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. J. Crampton, MD | ORA, Inc. | Principal Investigator |
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| Olopatadine Nasal Spray | Drug | Olopatadine Nasal Spray: 2660mcg BID |
|
| Saline Nasal Spray | Drug | Placebo |
|
| Headaches | Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| 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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