P03428

About this trial

Last updated 10 years ago

Study ID

P03428

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

6 to 12 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 19 years ago

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.

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