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This is a study of the effectiveness and safety of a new nasal spray for the relief of the symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid treatment), and an inactive placebo. The study hypothesis is that R926112 will be superior to placebo at the end of a week of testing and evaluation. The study does not have the power to determine how R926112 compares to Beconase.
Seven hundred fifty patients with histories of seasonal allergies will be screened in late summer and early fall at 25 sites across the U.S. Approximately 375 patients, based on severity of symptoms will be randomized among the treatments (150 to R926112, 150 to placebo, 75 to Beconase). During, and for about 2-3 weeks prior to the study, patients will have to abstain from other anti-allergy medications. Patients will fill out diary cards two times per day to record their symptoms. The entire study should take between 2-4 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R926112 | Drug | |||
| Beclomethasone dipropionate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total nasal symptom score from baseline over time |
| Measure | Description | Time Frame |
|---|---|---|
| Change in individual symptoms | ||
| Global therapeutic response | ||
| Quality of life score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliott Grossbard, M.D. | Rigel Pharmaceuticals | Study Director |
| Eli Meltzer, M.D. | Allergy and Asthma Medical Group and Research Center, San Diego | Principal Investigator |
| Harold Nelson, M.D. | National Jewish Medical Research Center, Denver | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15806000 | Background | Meltzer EO, Berkowitz RB, Grossbard EB. An intranasal Syk-kinase inhibitor (R112) improves the symptoms of seasonal allergic rhinitis in a park environment. J Allergy Clin Immunol. 2005 Apr;115(4):791-6. doi: 10.1016/j.jaci.2005.01.040. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |