Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)

Study Overview
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Brief Summary
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Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.

Detailed Description
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Children, ages 2-11, with a history of perennial allergic rhinitis

Official Title
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Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients

Conditions
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Rhinitis

Intervention / Treatment
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* Drug: Desloratadine (assigned by investigator as part of normal practice)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children patients of both sexes aged between 2-11 years, of either gender and any race Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation Minimum score for inclusion: 10 Capable of complying with the dosing regimen Free of any clinically significant disease (other than allergic rhinitis) Antihistamine must be justified by investigating doctor Exclusion Criteria: Patients with asthma who require chronic use of inhaled or systemic corticosteroids History of frequent, clinically significant sinusitis or chronic purulent postnasal drip Patients with rhinitis medicamentosa History of hypersensitivity to desloratadine or any of its excipients Doctor deems unsuitable

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Children with a history of perennial allergic rhinitis | Drug: Desloratadine (assigned by investigator as part of normal practice)<br>* Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits<br>* Other names: SCH 034117;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines. | Minimum of 7 days after initiation of desloratadine | 
| General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments | Physicians judged the subjects as good, excellent, fair, or poor. | Minimum of 7 days after initiation of desloratadine |