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

Merck Sharp & Dohme LLC100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Rhinitis

Interventions

LoratadineDRUG

loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg

BetamethasoneDRUG

loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Day 6 (Final visit)

Data from ClinicalTrials.gov

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