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This was a placebo controlled study designed to evaluate the effectiveness of desloratadine in relieving symptoms of allergic airway disease during the pollen season. Patients received desloratadine 10 mg or placebo once daily for 28 days, and had their allergy symptoms and side effects to medication measured on Day 1, Day 15, and Day 29 (one day after stopping study drug).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desloratadine 10 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine | Drug | Desloratadine 10 mg daily x 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 averaged over weeks 1 to 4. | Over weeks 1 to 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in chest symptoms, nasal symptoms, and eye symptom scores | Day 15 and Day 29 | |
| Interference with sleep and daily activities | Day 15 and Day 29 | |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who:
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| ID | Term |
|---|---|
| C121345 | desloratadine |
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| Placebo | Drug | Placebo daily x 28 days |
|
| Number of nocturnal awakenings due to chest symptoms |
| Day 15 and Day 29 |
| Overall Therapeutic Response to therapy of allergic airway disease symptoms (investigator and joint evaluation) | Day 15 and Day 29 |
| Change from Baseline in chest symptoms, nasal symptoms, and eye symptom scores | ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) |
| Change in FEV1, FVC, FEF(25%-75%), PEFR | ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) |
| Use of Proventil® HFA rescue medication | ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) |
| Interference with sleep and daily activities | ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) |
| Number of nocturnal awakenings due to chest symptoms | ALL TREATMENT VISITS (Day 1, Day 15, and Day 29) |