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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Loratadine
  • loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
• Drug: Betamethasone
  • loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• 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)
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Schering-Plough Industry

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00963573

Study ID Number: P03428

ClinicalTrials.gov Identifier: NCT00963573

Health Authority: Venezuela: Instituto Nacional de Higiene "Rafael Rangel"