Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)

Study Overview
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Brief Summary
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This study attempts to document the therapeutic value of combining loratadine antihistamine action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may facilitate treatment adherence by patients whereas providing an effective and rapid perennial allergic rhinitis (PAR) symptoms relief.

Official Title
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Efficacy and Safety of Loratadine-Betamethasone Oral Solution (1 mg/0.05 mg/1 mL) for Initial Treatment of Severe Perennial Allergic Rhinitis in School Age Children

Conditions
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Rhinitis

Intervention / Treatment
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* Drug: Loratadine
* Drug: Betamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of perennial allergic rhinitis. Age >= 6 years old and <= 12 years old. Patients in good general conditions, without any other relevant clinical condition except for perennial allergic rhinitis. Symptoms total score at admission >= 8 (out of 15 possible). Individual symptoms (score 0 to 3 points) were: Sneezing or nasal pruritus, eye reddening or pruritus, nasal congestion, wet nose or with secretion (sniffing), secretion sensation at pharynx (post-nasal dripping). Number of symptoms: At least three. Exclusion Criteria: Age < 6 years old or > 12 years old. Co-existence of acute sinusitis or some chronic condition different from asthma or atopic dermatitis. Presence of systemic fungal infections. Conscience or behavioral disturbances. Current oral or parenteral steroid treatment. Concomitant use of Phenobarbital, rifampicin, diphenylhydantoin or ephedrine. Known hypersensitivity to any of the study pharmacological combination components.

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: loratadine/betamethasone oral solution<br>loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg | Drug: Loratadine<br>* loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg<br>* Other names: SCH 029851;Drug: Betamethasone<br>* loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg<br>* Other names: SCH 029851;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy and safety of loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg, respectively, as an initial treatment for severe perennial allergic rhinitis in school age children |  | Day 6 (Final visit) |