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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis

Intervention: Loratadine (Drug); Betamethasone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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


Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: September 2003
Last updated: April 20, 2015

Page last updated: August 23, 2015

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