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

Phase 4

Completed

• Conditions: Rhinitis
• Interventions: Drug: Loratadine; Drug: Betamethasone

• Registration Number: NCT00963573
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
loratadine/betamethasone oral solution	Loratadine	loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
loratadine/betamethasone oral solution	Betamethasone	loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg

Primary Outcome Measures

Name	Time	Method
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)