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

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

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.

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.