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This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | desloratadine |
|
| 2 | Active Comparator | fexofenadine |
|
| 3 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desloratadine | Drug | desloratadine, 5 mg oral tablets, once daily for 15 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the efficacy of the study treatments with respect to the change from Baseline in the mean AM self-rated instantaneous total symptom score (TSS) (not including nasal congestion) averaged over the 15 days of treatment | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the mean AM/PM self-rated 12-hour reflective TSS (not including nasal congestion) averaged over the 15 days of treatment. | 15 days | |
| Change from Baseline in the mean AM self-rated instantaneous individual symptom scores, including nasal congestion, averaged over the 15 days of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16913264 | Result | Berger WE, Lumry WR, Meltzer EO, Pearlman DS. Efficacy of desloratadine, 5 mg, compared with fexofenadine, 180 mg, in patients with symptomatic seasonal allergic rhinitis. Allergy Asthma Proc. 2006 May-Jun;27(3):214-23. doi: 10.2500/aap.2006.27.2851. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
| C093230 | fexofenadine |
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| fexofenadine | Drug | fexofenadine, 180 mg tablets, once daily for 15 days; for purposes of blinding, fexofenadine tablets were over encapsulated |
|
|
| placebo | Drug | placebo, once daily for 15 days |
|
| 15 days |
| Change from Baseline in the mean AM/PM self-rated 12-hour reflective individual symptom scores, including nasal congestion, averaged over the 15 days of treatment. | 15 days |
| Joint physician-patient evaluation of response to therapy. | Day 8 and Day 15 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |