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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Rhinitis

Treatments

Drug: Loratadine

Drug: Betamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00963573

P03428

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No 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.