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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00963573

Enrollment

100

Registered

2009-08-21

Start date

2003-09-30

Completion date

2006-11-30

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis

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.

Interventions

DRUGLoratadine

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

DRUGBetamethasone

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026