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The purposes of this study are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Double-blind phase: Change from baseline in mean daily instantaneous (immediately prior to dosing) Total Nasal Symptom Score (TNSS) over the 4-week double-blind period | ||
| Open-label phase: The efficacy variable is the global evaluation of efficacy as rated by the physician and the subject |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline: in mean daily reflective (previous 24 hours) TNSS over 4-wk double-blind period | ||
| for mean daily instantaneous and reflective TNSS by week | ||
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Inclusion Criteria:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by-case basis prior to enrolling the subject. This must be documented by both the sponsor and the investigator.
No subject will be allowed to enroll in this study more than once.
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| Name | Affiliation | Role |
|---|---|---|
| Phyllis Diener, BS, MT (ASCP) | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis, Inc. | Bridgewater | New Jersey | 08807 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19441606 | Derived | Weinstein S, Qaqundah P, Georges G, Nayak A. Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension. Ann Allergy Asthma Immunol. 2009 Apr;102(4):339-47. doi: 10.1016/S1081-1206(10)60340-7. |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| for mean instantaneous and reflective daily scores for nasal stuffiness, nasal discharge, sneezing, nasal itching, and total eye symptoms by week and over four week double-blind period |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |