Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Efficacy and Safety of Desloratadine Syrup in Children Suffering From Seasonal Allergic Rhinitis With or Without Intermittent Asthma

Conditions
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Rhinitis, Allergic, Seasonal, Asthma

Intervention / Treatment
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* Drug: Desloratadine


Participation Criteria
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Eligibility Criteria
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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: Clinical history of sneezing, rhinorrhea (nasal discharge/running nose or post-nasal drip), nasal stuffiness/congestion and nasal itching and non-nasal symptoms (eye symptoms) as itching, burning, tearing and redness, during the previous pollen season Ascertained skin prick positivity (or RAST positivity) to one of the following: grasses, parietaria, birch, hazelnut (the skin test has to be performed within the last year) 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 persistent asthma (mild, moderate or severe) or perennial allergic rhinitis (PAR) 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Desloratadine<br>* desloratadine syrup; 5.0 mL once daily for 28 days<br>* Other names: Clarinex; Aerius; SCH 34117; descarboethoxyloratadine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |