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The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The doctor also rated how much relief the patient got from treatment and recorded any side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine | Drug | desloratadine syrup; 5.0 mL once daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of the efficacy of desloratadine in relieving the total nasal/non-nasal symptoms of seasonal allergic rhinitis | Baseline, Day 8, Day 15, Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that the Global Therapeutic Response is correlated with the degree of improvement of the total nasal/non-nasal symptoms severity score | Day 8, Day 15, Day 29 | |
| To evaluate the number of adverse events during the therapy | Day 8, Day 15, and Day 29 |
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Inclusion Criteria:
Children must be >= 6 to < 12 years of age of either sex and any race.
Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent
Children must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations
Children's parent(s) or legal representative(s) must understand and be able to adhere to dosing and visit schedules, agree to report concomitant medications and adverse events to the Investigator or designee
The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by:
Children must be clinically symptomatic with SAR at Visit 1 (day 1): the total (nasal + non nasal) symptoms score must be >= 8 with a nasal congestion score of >= 2, and the non-nasal symptoms severity score must be >= 2
Asthma symptoms (wheezing, cough, difficulty breathing, chest tightness) will be evaluated at visit 1 (day 1) and graded only for child with concomitant asthma
Exclusion Criteria:
Children who have not observed the designated washout periods for any of the prohibited medications
Children with rhinitis medicamentosa
Children who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a viral upper respiratory infection within 7 days prior to Visit 1 (day 1)
Children who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interfere with nasal airflow
Children who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
Children with a history of hypersensitivity to desloratadine or any of its excipients
Children who have any current clinically significant metabolic, cardiovascular, hepatic, renal, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety
A known lack of response to H1-antihistamines
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15679739 | Result | Rossi GA, Tosca MA, Passalacqua G, Bianchi B, Le Grazie C, Canonica GW. Evidence of desloratadine syrup efficacy and tolerability in children with pollen-induced allergic rhinitis. Allergy. 2005 Mar;60(3):416-7. doi: 10.1111/j.1398-9995.2005.00714.x. No abstract available. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |